Standards of Medical Care in Diabetes — 2016

Standards of Medical Care in Diabetes — 2016
This purpose of this talk is to overview the 2016 American Diabetes Association Standards of Medical Care in Diabetes. These Standards comprise all of the current and key clinical practice recommendations of the American Diabetes Association. [SLIDE] Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S1 1

Standards of Care Funded out Association’s general revenues and does not use industry support. Slides correspond with sections within the Standards of Medical Care in Diabetes—2016. Reviewed and approved by the Executive Committee of the Association’s Board of Directors. A few notes on the Standards of Care: The Association funds development of the Standards of Care and all Association position statements out of its general revenues and does not use industry support for these purposes [CLICK] The slides are organized to correspond with sections within the 2016 Standards of Care. As we go through I’ll make note of where we are within the document. [CLICK] Though not every section in the document is represented, these slides do incorporate the most salient points from the Position Statement As with all Association position statements, the Standards of Care are reviewed and approved by the Executive Committee of the Association’s Board of Directors, which includes health care professionals, scientists, and lay people. [SLIDE] 2

Professional.diabetes.org/SOC
Process ADA’s Professional Practice Committee (PPC) conducts annual review & revision. Searched Medline for human studies related to each subsection and published since January 1, 2015. Recommendations revised per new evidence, for clarity, or to better match text to strength of evidence. Professional.diabetes.org/SOC These Standards of Care are revised annually by the ADA’s multidisciplinary Professional Practice Committee (PPC) [CLICK] For the 2016 revision, PPC members systematically searched Medline for human studies related to each subsection and published since 1 January [CLICK] Recommendations were revised based on new evidence or, in some cases, to clarify the prior recommendations or match the strength of the word to the strength of the evidence [CLICK] A table linking the changes in the recommendations to new evidence can be reviewed at professional.diabetes.org/SOC (Standards of Care) [CLICK] The Association and the Professional Practice Committee welcome feedback from the larger clinical community, which you can also submit at this URL. [SLIDE] 3

Clinical Practice Recommendations Evidence Grading System
Clear evidence from adequately-powered, well-conducted, generalizable RCTs, including evidence from a multicenter trial or meta-analysis that incorporated quality ratings in the analysis; Compelling nonexperimental evidence; Supportive evidence from adequately-powered, well-conducted RCTs. B Supportive evidence from a well-conducted cohort studies Supportive evidence from a well-conducted case-control study C Supportive evidence from poorly controlled or uncontrolled studies or evidence from observational studies with high potential for bias Evidence from case series or case reports Conflicting evidence with the weight of evidence supporting the recommendation E Expert consensus or clinical experience Here is the Association’s evidence grading system in use for these clinical practice recommendations, used to clarify and codify the evidence that forms the basis for each of the recommendations in the 2016 Standards of Medical Care in Diabetes. The level of evidence that supports each recommendation is listed after each recommendation using the letters A, B, C, or E. As we proceed through this presentation you’ll see these grades next to each of the recommendations listed. I won’t call them out each time, but they’re there for your reference. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Introduction. Diabetes Care 2016; 39 (Suppl. 1): S1-S2 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S15; Table 1 4

Terminology No longer using the term “diabetic.”
Diabetes does not define people. People with diabetes are individuals with diabetes, not “diabetics.” “Diabetic” will continue to be used related to complications, e.g., “diabetic retinopathy.” The Association made one point of clarification this year which we hope clinicians, advocates, journalists, and the general public will adopt: In alignment with our longstanding informal policy Association-wide, the Standards of Care will no longer use the term “diabetic” to refer to patients with diabetes. This decision is in alignment with the American Diabetes Association’s position that diabetes does not define people. Those with diabetes are individuals with diabetes, not “diabetics.” ADA will continue to use the term “diabetic” as an adjective for complications related to diabetes (e.g., diabetic retinopathy). [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Introduction. Diabetes Care 2016; 39 (Suppl. 1): S1-S2 5

Strategies for Improving Diabetes Care
Section 1, Strategies for Improving Diabetes Care covers several key components… [SLIDE] 6

Strategies for Improving Care
Key Recommendations Diabetes Care Concepts Care Delivery Systems Optimize Provider and Team Behavior Support Patient Behavior Change Change the System of Care What to Do When Treatment Goals are Not Met Tailoring Treatment to Vulnerable Populations Including: Key recommendations [CLICK] Diabetes Care Concepts, [CLICK] Care Delivery Systems, including three key objectives: 1: Optimize Provider and Team Behavior 2: Support Patient Behavior Change And 3: Change the System of Care [CLICK] And two sections that are new this year, one addressing what to do when treatment goals are not met and another one on tailoring treatment to vulnerable populations. So, we have a lot to cover; let’s get started. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Strategies for improving diabetes care. Diabetes Care 2016; 39 (Suppl. 1): S6-S12 7

Key Recommendations Use a patient-centered communication style that incorporates patient preferences, assesses literacy and numeracy, and addresses cultural barriers to care. B Treatment decisions should be timely and based on evidence-based guidelines that are tailored to patient preferences, prognoses, and comorbidities. B A few key recommendations are intended to cover all sections of the Standards of Care and include: Use a patient-centered communication style that incorporates patient preferences, assesses literacy and numeracy, and addresses cultural barriers to care. Treatment decisions should be timely and based on evidence-based guidelines that are tailored to patient preferences, prognoses, and comorbidities. [SLIDE] 8

Key Recommendations (2)
Care should be aligned with components of the Chronic Care Model to ensure productive interactions between a prepared proactive practice team and an informed activated patient. A When feasible, care systems should support team-based care, community involvement, patient registries, and decision support tools to meet patient needs. B Care should be aligned with components of the Chronic Care Model to ensure productive interactions between a prepared proactive practice team and an informed activated patient. A When feasible, care systems should support team-based care, community involvement, patient registries, and decision support tools to meet patient needs. B [SLIDE] 9

Diabetes Care Concepts
3 key themes are woven throughout the Standards of Care in Diabetes: Patient-Centeredness: One size does not fit all. These Standards provide guidance for when and how to adapt recommendations. Diabetes Across the Lifespan: There is a need to improve coordination between clinical teams as patients pass through different stages of the life span. Advocacy for Patients with Diabetes: Given the tremendous toll that obesity, physical inactivity, and smoking have on the health of patients with diabetes, efforts are needed to address and change the societal determinants at the root of these problems. Moving along to Diabetes Care Concepts, three key themes are woven throughout the Standards of Care: Patient Centeredness, addressing diabetes across the lifespan, and advocacy for people with diabetes. [CLICK] First, patient-centeredness, or when and how to adapt recommendations to meet the needs of individual patients. [CLICK] Second, diabetes across the lifespan. As our patients pass through different lifestages, such as from pediatric to adult care, how can we improve coordination between clinical teams? [CLICK] And finally, advocacy for patients with diabetes. We know that obesity, physical inactivity, and smoking have a tremendous toll on the health of our patients, and we as health care providers must work to address and change the societal determinants that are at the root of these problems. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Strategies for improving diabetes care. Diabetes Care 2016; 39 (Suppl. 1): S6-S12 Reference 1. American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S61 10

Care Delivery Systems 33-49% of patients still do not meet targets for A1C, blood pressure, or lipids. 14% meet targets for all A1C, BP, lipids, and nonsmoking status. Progress in CVD control is slowing. Substantial system-level improvements are needed. Delivery system is fragmented, lacks clinical information capabilities, duplicates services & is poorly designed. Over the last ten years we’ve seen steady improvement in the proportion of patients with diabetes who are treated with statins and achieving recommended levels for A1C, blood pressure, and LDL, but nevertheless, 33-49% of patients still do not meet targets for glycemic, blood pressure, or cholesterol control, and [CLICK] only 14% meet targets for all three measures plus nonsmoking status. [CLICK] Evidence also suggests that our progress in control of cardiovascular disease is slowing. [CLICK] Even after adjusting for patient factors, the persistent variation in quality of diabetes care across providers and practice settings indicates that there is potential for substantial system- level improvements. [CLICK] A major barrier to optimal care is a delivery system that is often fragmented, lacks clinical information capabilities, duplicates services, and is poorly designed for the coordinated delivery of chronic care. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Strategies for improving diabetes care. Diabetes Care 2016; 39 (Suppl. 1): S6-S12 11

Chronic Care Model Six Components: Delivery system design
Self-management support Decision support Clinical information systems Community resources & policies Health systems But we know that the chronic care model has been shown to be an effective framework for improving the quality of diabetes care. The CCM includes six core elements for the provision of optimal care of patients with chronic disease: Delivery system design, or moving from a reactive to a proactive care delivery system where planned visits are coordinated through a team-based approach), Self-management support, Decision support (basing care on evidence-based, effective care guidelines), Clinical information systems, including using registries that can provide patient-specific and population-based support to the care team Community resources and policies, such as identifying or developing resources to support healthy lifestyles), and Health systems that create a quality-oriented culture The National Diabetes Education Program (NDEP) maintains an online resource ( to help health care professionals design and implement more effective health care delivery systems for those with diabetes. This work includes three specific objectives… [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Strategies for improving diabetes care. Diabetes Care 2016; 39 (Suppl. 1): S6-S12 12

Objective 1: Optimize Provider and Team Behavior
For patients who have not achieved beneficial levels of control in blood pressure, lipids, or glucose, the care team should prioritize timely & appropriate intensification of lifestyle and/or pharmaceutical therapy. Strategies include: Explicit goal setting with patients Identifying and addressing language, numeracy, and/or cultural barriers to care Integrating evidence-based guidelines Incorporating care management teams Objective 1: Optimize Provider and Team Behavior The care team should prioritize timely and appropriate intensification of lifestyle and/or pharmaceutical therapy of patients who have not achieved beneficial levels of blood pressure, lipid, or glucose control1 As outlined on this slide, the following [CLICK] strategies each have been shown to optimize provider and team behavior and thereby catalyze reduction in A1C, blood pressure, and LDL cholesterol2 Explicit goal setting with patients Identifying and addressing language, numeracy, or cultural barriers to care Integrating evidence-based guidelines and clinical information tools into the process of care; and Incorporating care management teams including nurses, pharmacists, and other providers [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Strategies for improving diabetes care. Diabetes Care 2016; 39 (Suppl. 1): S6-S12 References Davidson MB. How our current medical care system fails people with diabetes: lack of timely, appropriate clinical decisions. Diabetes Care 2009;32:370–372 American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S61 13

Objective 2: Support Patient Behavior Change
Implement a systematic approach to support patient behavior change efforts, including: Healthy lifestyle: physical activity, healthy eating, tobacco cessation, weight management, effective coping Disease self-management: taking and managing medication, self-monitoring of glucose and blood pressure when clinically appropriate Prevention of diabetes complications: self- monitoring of foot health, active participation in screening for eye, foot, and renal complications, and immunizations The second objective in helping health care professionals design and implement more effective health care delivery systems for our patients with diabetes is supporting patient behavior change, including: Healthy lifestyle, which includes physical activity, healthy eating, tobacco cessation, weight management, and strategies for effective coping. Disease self-management, including taking and managing medication, self-monitoring of blood glucose and blood pressure, and Prevention of diabetes complications, which includes self-monitoring of foot health, active participation in screening for eye, foot, and renal complications, and immunizations. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Strategies for improving diabetes care. Diabetes Care 2016; 39 (Suppl. 1): S6-S12 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S62 Duncan I, Birkmeyer C, Coughlin S, Li QE, Sherr D, Boren S. Assessing the value of diabetes education. Diabetes Educ 2009;35:752–760 Berikai P, Meyer PM, Kazlauskaite R, Savoy B, Kozik K, Fogelfeld L. Gain in patients’ knowledge of diabetes management targets is associated with better glycemic control. Diabetes Care 2007;30:1587–1589 Funnell MM, Brown TL, Childs BP, et al. National Standards for Diabetes Self-Management Education. Diabetes Care 2007;30:1630–1637 Klein S, Sheard NF, Pi-Sunyer X, et al.; American Diabetes Association; North American Association for the Study of Obesity; American Society for Clinical Nutrition. Weight management through lifestyle modification for the prevention and management of type 2 diabetes: rationale and strategies: a statement of the American Diabetes Association, the North American Association for the Study of Obesity, and the American Society for Clinical Nutrition. Diabetes Care 2004;27:2067–2073 Norris SL, Zhang X, Avenell A, et al. Efficacy of pharmacotherapy for weight loss in adults with type 2 diabetes mellitus: a meta-analysis. Arch Intern Med 2004;164:1395–1404 14

Objective 3: Change the Care System
Successful practices prioritize providing a high quality of care. Changes that have been shown to increase quality of care include: Basing care on evidence-based guidelines Expanding the role of teams to implement more intensive disease management strategies Redesigning the care process Implementing electronic health record tools Activating and educating patients Finally, the third objective, Change the System of Care An institutional priority in most successful care systems is providing a high quality of care. Changes that have been shown to increase quality of diabetes care include: basing care on evidence-based guidelines; [CLICK] expanding the role of teams to implement more intensive disease management strategies; [CLICK] redesigning the care process; [CLICK] implementing electronic health record tools; [CLICK] activating and educating patients, (continued on next slide) [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Strategies for improving diabetes care. Diabetes Care 2016; 39 (Suppl. 1): S6-S12 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S62 Tricco AC, Ivers NM, Grimshaw JM, et al. Effectiveness of quality improvement strategies on the management of diabetes: a systematic review and metaanalysis. Lancet 2012;379:2252–2261 Bojadzievski T, Gabbay RA. Patient centered medical home and diabetes. Diabetes Care 2011;34:1047–1053. Rosenthal MB, Cutler DM, Feder J. The ACO rules—striking the balance between participation and transformative potential. N Engl J Med 2011;365:e6 Washington AE, Lipstein SH: The Patient-Centered Outcomes Research Institute: Promoting better information, decisions, and health. N Engl J Med 2011;365:e31 15

Objective 3: Change the Care System (2)
Successful practices prioritize providing a high quality of care. Changes that have been shown to increase quality of care include: Removing financial barriers and reducing patient out-of-pocket costs Identifying community resources and public policy that supports healthy lifestyles Coordinated primary care, e.g., through Patient-Centered Medical Home Changes to reimbursement structure Objective 3: Change the System of Care removing financial barriers and reducing patient out-of-pocket costs for diabetes education, eye exams, self-monitoring of blood glucose, and necessary medications, [CLICK] Identifying, developing, and engaging community resources and public policy that support healthy lifestyles; [CLICK] Initiatives such as the Patient-Centered Medical Home show promise for improving outcomes through coordinated primary care and offer new opportunities for team-based chronic disease care; and finally, [CLICK] Additional strategies to improve diabetes care include reimbursement structures that reward the provision of appropriate and high-quality care, and incentives that accommodate personalized care goals. In sum, optimal diabetes management requires an organized, systematic approach and the involvement of a coordinated team of dedicated health care professionals working in an environment where patient-centered high-quality care is a priority. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Strategies for improving diabetes care. Diabetes Care 2016; 39 (Suppl. 1): S6-S12 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S62 Tricco AC, Ivers NM, Grimshaw JM, et al. Effectiveness of quality improvement strategies on the management of diabetes: a systematic review and metaanalysis. Lancet 2012;379:2252–2261 Bojadzievski T, Gabbay RA. Patient centered medical home and diabetes. Diabetes Care 2011;34:1047–1053. Rosenthal MB, Cutler DM, Feder J. The ACO rules—striking the balance between participation and transformative potential. N Engl J Med 2011;365:e6 Washington AE, Lipstein SH: The Patient-Centered Outcomes Research Institute: Promoting better information, decisions, and health. N Engl J Med 2011;365:e31 16

When Treatment Goals Aren’t Met
Seek evidence-based approaches that improve clinical outcomes and quality of life. Recent reviews of quality improvement strategies have not identified one approach that’s more effective than others. Translating Research Into Actions for Diabetes (TRIAD) study provided objective data. In general, providers should seek evidence-based approaches that improve the clinical outcomes and quality of life of patients with diabetes. [CLICK] Recent reviews of quality improvement strategies in diabetes care have not identified a particular approach that’s more effective than others, [CLICK] but the TRIAD study provided some data and insight. I’ll briefly cover a few of those points next. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Strategies for improving diabetes care. Diabetes Care 2016; 39 (Suppl. 1): S6-S12 17

TRIAD: Processes of Care
Including: Periodic testing of A1C, lipids & urine albumin Examining retina and feet Advising on aspirin use Smoking cessation Performance feedback, reminders & structured care may influence providers to improve processes of care. The TRIAD study found it useful to divide interventions into two categories, first, those that affect the processes of care. Processes of care included periodic testing of A1C, lipids, and urine albumin, examining the retina and feet, advising on aspirin use, and smoking cessation. The TRIAD results suggest that providers control these activities. Performance feedback, reminders and structured care (e.g. guidelines, formal case management and patient education resources) may influence providers to improve processes of care. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Strategies for improving diabetes care. Diabetes Care 2016; 39 (Suppl. 1): S6-S12 18

TRIAD: Intermediate Outcomes
Better address barriers to treatment intensification and adherence than processes of care. In 35% of cases, uncontrolled A1C, BP, or lipids was associated with lack of treatment intensification. Treatment intensification is associated with improved A1C, BP, and lipid control. And the second TRIAD intervention category includes intermediate outcomes. These intermediate outcomes address the barriers to treatment intensification and adherence (such as A1C, blood pressure, and lipid goals) that are not adequately addressed by processes of care. [CLICK] TRIAD showed that in 35% of cases, uncontrolled A1C, blood pressure, or lipids was associated with a lack of treatment intensification, defined as a failure to either increase a drug dose or change a drug class. Treatment intensification was associated with improvement in A1C, hypertension, and hyperlipidemia control. A large multicenter study confirmed the strong association between treatment intensification and improved A1C. [CLICK] So, all of that to say, just the process of periodic A1C testing will not, in and of itself, lower A1C. It’s important to intensify treatment to meet those goals. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Strategies for improving diabetes care. Diabetes Care 2016; 39 (Suppl. 1): S6-S12 19

TRIAD: Intermediate Outcomes & Adherence
Poor adherence was associated with uncontrolled A1C, blood pressure, or lipids in 23% of TRIAD cases. “Adequate” adherence: 80% In 23% of the TRIAD cases, poor adherence was associated with uncontrolled A1C, blood pressure, or lipids, with “adequate” adherence defined as 80%,. It’s a good metric to use to find and track poor adherence and to help guide system improvement efforts to overcome the barriers to adherence [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Strategies for improving diabetes care. Diabetes Care 2016; 39 (Suppl. 1): S6-S12 20

TRIAD: Barriers to Adherence
Patient factors: Remembering to get or take medicines Fear Depression Health beliefs Medication factors: Complexity Multiple daily dosing Cost Side effects System factors: Inadequate follow up or support These barriers to adherence include patient factors, such as remembering to get or take medicines, fear, depression, or health beliefs; [CLICK] medication factors such as complexity, multiple daily dosing, cost, side effects), and [CLICK] system factors, such as inadequate follow up or support. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Strategies for improving diabetes care. Diabetes Care 2016; 39 (Suppl. 1): S6-S12 21

Achieving Intermediate Outcomes
Assess adherence: ≥ 80% consider treatment intensification ≤ 80% consider initiating or changing to a different medication class. Explore barriers to adherence Establish a follow-up plan So, how do you achieve those intermediate outcomes? A systematic approach to achieving intermediate outcomes involves three steps: Assessing a patient’s current adherence is your first priority. If adherence is 80% or above then treatment intensification should be considered (e.g. up-titration). If medication up- titration is not a viable option, then consider initiating or changing to a different medication class. [CLICK] Explore barriers to adherence with the patient/caregiver and find a mutually agreeable approach to overcoming the barriers [CLICK] Establish a follow up plan that confirms the planned treatment change and assess progress in reaching the target. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Strategies for improving diabetes care. Diabetes Care 2016; 39 (Suppl. 1): S6-S12 22

Vulnerable Populations
Ethnic, cultural, religious & gender differences and socioeconomic status affect health care access, diabetes prevalence, and outcomes. Type 2 diabetes is more common in: Women with hx of GDM Individuals with HTN or dyslipidemia African Americans, Native Americans, Hispanic/Latinos & Asian Americans Finally under strategies for improving care, we know that ethnic, cultural, religious, and gender as well as socioeconomic status affect health care access, diabetes prevalence, and diabetes outcomes. [CLICK] For example, we know that type 2 diabetes is more common in women with a history of gestational diabetes, in individuals with hypertension or dyslipidemia, and among certain racial and ethnic groups including African Americans, Native Americans, Hispanic/Latinos, and Asian Americans. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Strategies for improving diabetes care. Diabetes Care 2016; 39 (Suppl. 1): S6-S12 23

Tailoring Treatment Diabetes treatment must be individualized, patient-centered, and culturally appropriate. In Asian Americans, consider DM testing in adults of any age with 1 risk factor and a BMI ≥23. Leverage NQF’s National Voluntary Consensus Standards for Ambulatory Care – Measuring Healthcare Disparities. Clinicians need to pay particular attention to populations that may be disproportionately at risk, and treatment must be individualized, patient-centered, and culturally appropriate. [CLICK] For example, some recent studies have recommended lowering the BMI cutpoint for testing in Asian Americans to a BMI of 23, instead of a BMI of 25 as in other adults. [CLICK] To decrease disparities, all providers and groups are encouraged to use the National Quality Forum’s National Voluntary Consensus Standards for Ambulatory Care—Measuring Healthcare Disparities [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Strategies for improving diabetes care. Diabetes Care 2016; 39 (Suppl. 1): S6-S12 24

Health Disparities Lack of health insurance Food insecurity (FI)
Carefully evaluate hyperglycemia and hypoglycemia and propose solutions A Recognize that homelessness, poor literacy, and poor numeracy often occur with food insecurity; appropriate resources should be made available for patients with diabetes. A In particular the Association calls out two key areas that affect diabetes care: First, lack of health insurance. The Affordable Care Act has improved access to health care, however, many remain without coverage. And secondly, food insecurity-- the unreliable availability of nutritious food and the inability to consistently obtain food without resorting to socially unacceptable practices. About 1 in every 7 people in the US is food insecure. The Association offers two key recommendations for dealing with FI: First, carefully evaluate both hyper and hypoglycemia in the context of food insecurity and propose solutions accordingly. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Strategies for improving diabetes care. Diabetes Care 2016; 39 (Suppl. 1): S6-S12 25

Cognitive Dysfunction
Intensive glucose control is not advised for the improvement of poor cognitive function in hyperglycemic individuals with T2DM. B In individuals with poor cognitive function or severe hypoglycemia, glycemic therapy should be tailored to avoid significant hypoglycemia. C Specific to your patients with cognitive dysfunction, the most common form of which is dementia, including Alzheimer’s, the Association offers four recommendations: First, intensive glucose control is not advised for the improvement of poor cognitive function in hyperglycemic individuals with type 2 diabetes, [CLICK] Second, in individuals with poor cognitive function or severe hypoglycemia, glycemic therapy should be tailored to avoid significant hypoglycemia. [SLIDE[ American Diabetes Association Standards of Medical Care in Diabetes. Strategies for improving diabetes care. Diabetes Care 2016; 39 (Suppl. 1): S6-S12 26

Cognitive Dysfunction (2)
In individuals with diabetes at high CVD risk, the cardiovascular benefits of statin therapy outweigh the risk of cognitive dysfunction. A If a second-generation antipsychotic medication is prescribed, changes in weight, glycemic control, and cholesterol levels, should be carefully monitored and the treatment regimen reassessed. C In individuals with diabetes at high cardiovascular risk, the cardiovascular benefits of statin therapy outweigh the risk of cognitive dysfunction [CLICK] And, finally, if a second-generation antipsychotic medication is prescribed, changes in weight, glycemic control, and cholesterol levels, should be carefully monitored and the treatment regimen reassessed. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Strategies for improving diabetes care. Diabetes Care 2016; 39 (Suppl. 1): S6-S12 27

Human Immunodeficiency Virus (HIV)
Screen patients with HIV for diabetes and prediabetes before starting antiretroviral (ARV) therapy, and 3 months after starting or changing it. E If initial screening results are normal, check fasting glucose annually. E If prediabetes is detected, continue to measure levels every 3-6 months to monitor for progression to diabetes. E Also included in the section on tailoring treatment is diabetes care in patients with HIV. Specifically, the Association recommends that patients with HIV be screened for diabetes and prediabetes with a fasting glucose level before starting antiretroviral therapy, and again 3 months after starting or changing it. [CLICK] If initial screening results are normal, checking fasting glucose each year is advised. [CLICK] If prediabetes is detected, continue to measure levels every 3-6 months to monitor for progression to diabetes. And all of that is an “E” evidence rating, based on expert opinion. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Strategies for improving diabetes care. Diabetes Care 2016; 39 (Suppl. 1): S6-S12 28

Classification and Diagnosis of Diabetes
Moving on to section two, Classification and Diagnosis of Diabetes…. [SLIDE] 29

Classification & Diagnosis
Diagnostic Tests for Diabetes Categories of Increased Risk Type 1 Diabetes Type 2 Diabetes Gestational Diabetes Monogenic Diabetes Syndromes Cystic Fibrosis-Related Diabetes This section includes several key areas, such as classification of and diagnostic tests for diabetes, categories of increased risk, type 1 and type 2 diabetes, GDM, MODY, and CFRD, or Cystic Fibrosis-Related Diabetes. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Classification and diagnosis of diabetes. Diabetes Care 2016; 39 (Suppl. 1): S13-S22 30

Classification of Diabetes
Type 1 diabetes β-cell destruction Type 2 diabetes Progressive insulin secretory defect Gestational Diabetes Mellitus (GDM) Other specific types of diabetes Monogenic diabetes syndromes Diseases of the exocrine pancreas, e.g., cystic fibrosis Drug- or chemical-induced diabetes The classification of diabetes includes four clinical categories: Type 1 diabetes, due to β-cell destruction, usually leading to absolute insulin deficiency; [CLICK] Type 2 diabetes, due to a progressive insulin secretory defect on the background of insulin resistance; [CLICK] Gestational diabetes mellitus, which is diabetes diagnosed during pregnancy that is not clearly overt diabetes [CLICK] Other specific types of diabetes due to other causes; e.g., genetic defects in β-cell function, genetic defects in insulin action, diseases of the exocrine pancreas (such as cystic fibrosis), and drug- or chemical-induced diabetes (such as in the treatment of HIV/AIDS or after organ transplantation) [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Classification and diagnosis of diabetes. Diabetes Care 2016; 39 (Suppl. 1): S13-S22 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S14 31

Criteria for the Diagnosis of Diabetes
Fasting plasma glucose (FPG) ≥126 mg/dL (7.0 mmol/L) OR 2-h plasma glucose ≥200 mg/dL (11.1 mmol/L) during an OGTT A1C ≥6.5% Random plasma glucose ≥200 mg/dL (11.1 mmol/L) The same tests are used to screen for and diagnose diabetes and to detect people with prediabetes. These include: Fasting plasma glucose (FPG) ≥126 mg/dL OR 2-hour plasma glucose ≥200 mg/dL during an OGTT A1C ≥6.5% Or in a patient with classic symptoms of hyperglycemia a random plasma glucose ≥ 200 can also be used. The subsequent slides examine each of the criteria in greater detail. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Classification and diagnosis of diabetes. Diabetes Care 2016; 39 (Suppl. 1): S13-S22 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S15; Table 2 32

Fasting Plasma Glucose & 2 hr OGTT
Fasting plasma glucose (FPG) * ≥126 mg/dL (7.0 mmol/L) OR 2-h plasma glucose ≥200 mg/dL * (11.1 mmol/L) during an OGTT * In the absence of unequivocal hyperglycemia, result should be confirmed by repeat testing. Either the Fasting Plasma Glucose (FPG) or the 2 hour Oral Glucose Tolerance Test may be used to screen for or diagnose diabetes. Diagnostic cutpoints are listed on this slide. It’s worth noting that the concordance between these two tests is imperfect, as is the concordance between A1C and either glucose-based test. Numerous studies have confirmed that, compared with FPG cut points and A1C, the 2-h PG value diagnoses more people with diabetes. For the fasting plasma glucose, fasting is defined as no caloric intake for at least 8 hours prior. This sometimes can be hard to achieve; patients don’t count the cup of coffee they had on the way to the lab, and forget about the two tablespoons of sugar that are in it. The 2-hour oral glucose tolerance test is conducted after a 75g load. This is slightly more achievable, but many patients object to sitting around the office, waiting. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Classification and diagnosis of diabetes. Diabetes Care 2016; 39 (Suppl. 1): S13-S22 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S15; Table 2 Cowie CC, Rust KF, Byrd-Holt DD, et al. Prevalence of diabetes and high risk for diabetes using A1C criteria in the U.S. population in Diabetes Care 2010;33:562–568 Picón MJ, Murri M, Muňoz A, Fernández-Garcia JC, Gomez-Huelgas R, Tinahones FJ. Hemoglobin A1c versus oral glucose tolerance test in postpartum diabetes screening. Diabetes Care 2012;35:1648–1653 33

A1C ≥6.5% * Performed in a laboratory using a method that is NGSP certified and standardized to the DCCT assay – POC testing not recommended Greater convenience, preanalytical stability, and less day-to-day perturbations than FPG and OGTT Consider cost, age, race/ethnicity, anemia, etc. One way to combat both of those issues is with the A1C. This test should be performed using a method certified by the National Glycohemoglobin Standardization Program (NGSP) and standardized or traceable to the Diabetes Control and Complications Trial (DCCT) reference assay [CLICK] Although point-of-care (POC) assays may be NGSP-certified, proficiency testing is not mandated for performing the test, so use of these assays for diagnostic purposes may be problematic [CLICK] The A1C has several advantages to the FPG and OGTT, including greater convenience (fasting not required), possibly greater preanalytical stability, and less day-to-day perturbations during periods of stress and illness [CLICK] But, these advantages must be balanced by greater cost, the limited availability of A1C testing in certain regions of the developing world, and the incomplete correlation between A1C and average glucose in certain individuals [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Classification and diagnosis of diabetes. Diabetes Care 2016; 39 (Suppl. 1): S13-S22 References International Expert Committee: International Expert Committee report on the role of the A1C assay in the diagnosis of diabetes. Diabetes Care 2009;32:1327–1334 American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S15; Table 2 Ziemer DC, Kolm P, Weintraub WS, et al. Glucose-independent, black-white differences in hemoglobin A1c levels: a cross-sectional analysis of 2 studies. Ann Intern Med 2010;152:770–777 Kumar PR, Bhansali A, Ravikiran M, et al. Utility of glycated hemoglobin in diagnosing type 2 diabetes mellitus: a community-based study. J Clin Endocrinol Metab 2010;95:2832–2835 34

Random plasma glucose ≥200 mg/dL
In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis And in patients with clear symptoms of hyperglycemia you can also diagnose with a random plasma glucose. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Classification and diagnosis of diabetes. Diabetes Care 2016; 39 (Suppl. 1): S13-S22 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S15–S16;Table 2 35

Recommendations: Prediabetes
Testing should begin at age 45 for all patients, particularly those who are overweight or obese. B Consider testing for prediabetes in asymptomatic adults of any age w/ BMI ≥25 kg/m2 or ≥23 kg/m2 (in Asian Americans) who have 1 or more add’l risk factors for diabetes. B If tests are normal, repeat at a minimum of 3-year intervals. C This is new this year– in order to clarify the relationship between age, BMI, and risk for type 2 diabetes and prediabetes, the Association revised the screening recommendations to now recommend testing all adults beginning at age 45 years, regardless of weight. [CLICK] Testing is also recommended for asymptomatic adults of any age who are overweight or obese and who have one or more additional risk factors for diabetes. [CLICK] If tests are normal, the Association recommends repeat testing at least every 3 years. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Classification and diagnosis of diabetes. Diabetes Care 2016; 39 (Suppl. 1): S13-S22 36

Recommendations: Prediabetes (2)
FPG, 2-h PG after 75-g OGTT, and A1C, are equally appropriate for prediabetes testing. B In patients with prediabetes, identify and, if appropriate, treat other CVD risk factors. B Consider prediabetes testing in overweight/obese children and adolescents with 2 or more add’l diabetes risk factors. E Any of the three tests we discussed a few slides ago– FPG, OGTT, or A1C-- are appropriate for screening of prediabetes; [CLICK] In your patients with prediabetes, do identify and treat other cardiovascular risk factors as appropriate. [CLICK] And finally, consider prediabetes testing in overweight or obese children and adolescents when they have 2 or more additional risk factors. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Classification and diagnosis of diabetes. Diabetes Care 2016; 39 (Suppl. 1): S13-S22 37

Prediabetes* FPG 100–125 mg/dL (5.6–6.9 mmol/L): IFG
OR 2-h plasma glucose 140–199 mg/dL (7.8–11.0 mmol/L): IGT A1C 5.7–6.4% Here are the diagnostic cutpoints for prediabetes across the three tests. Note that risk is continuous, extending below the lower limit of a range and becoming disproportionately greater at higher ends of the range. [SLIDE] * For all three tests, risk is continuous, extending below the lower limit of a range and becoming disproportionately greater at higher ends of the range. American Diabetes Association Standards of Medical Care in Diabetes. Classification and diagnosis of diabetes. Diabetes Care 2016; 39 (Suppl. 1): S13-S22 References Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes Care 1997;20:1183–1197 Genuth S, Alberti KG, Bennett P, et al., for the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Follow-up report on the diagnosis of diabetes mellitus. Diabetes Care 2003;26:3160–3167 American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37suppl 1):S16; Table 3 38

Recommendation: Screening for Type 1 Diabetes
Blood glucose rather than A1C should be used to dx type 1 diabetes in symptomatic individuals. E Inform relatives of patients with T1D of the opportunity to be tested for type 1 diabetes risk, but only in the setting of a clinical research study. E Moving on to type 1 diabetes screening recommendations, these patients often present with acute symptoms of diabetes and markedly elevated blood glucose levels, and some cases are diagnosed with life-threatening ketoacidosis. In these cases, knowing the blood glucose level is critical because, in addition to confirming that symptoms are due to diabetes mellitus, this will inform management decisions. Some providers may also want to know the A1C to determine how long a patient has had hyperglycemia. Therefore the Association recommends that blood glucose rather than A1c should be used to diagnose acute onset type 1 diabetes in those with symptoms of hyperglycemia. [CLICK] While there is currently a lack of accepted screening programs, consider referring relatives of those with type 1 diabetes for antibody testing for risk assessment in the setting of a clinical research study, which can be identified at diabetestrialnet.org [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Classification and diagnosis of diabetes. Diabetes Care 2016; 39 (Suppl. 1): S13-S22 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S18 Imperatore G, Boyle JP, Thompson TJ, et al.; SEARCH for Diabetes in Youth Study Group. Projections of type 1 and type 2 diabetes burden in the U.S. population aged <20 years through 2050: dynamic modeling of incidence, mortality, and population growth. Diabetes Care 2012;35:2515–2520 Lipman TH, Levitt Katz LE, Ratcliffe SJ, et al. Increasing incidence of type 1 diabetes in youth: twenty years of the Philadelphia Pediatric Diabetes Registry. Diabetes Care 2013;36:1597–1603 Pettitt DJ, Talton J, Dabelea D, et al. Prevalence of diabetes mellitus in U.S. youth in 2009: the SEARCH for Diabetes in Youth Study. Diabetes Care. 16 September 2013 [Epub ahead of print] 39

Recommendations: Screening for Type 2 Diabetes
Consider testing in asymptomatic adults of any age with BMI ≥25 kg/m2 or ≥23 kg/m2 in Asian Americans who have 1 or more add’l dm risk factors. B For all patients, testing should begin at age 45 years. B If tests are normal, repeat testing carried out at a minimum of 3-year intervals is reasonable. C Type 2 diabetes, previously referred to as “non-insulin-dependent diabetes” or “adult-onset diabetes,” accounts for 90–95% of all diabetes. This form encompasses individuals who have insulin resistance and usually relative (rather than absolute) insulin deficiency. At least initially, and often throughout their lifetime, patients with type 2 diabetes may not need insulin treatment to survive. These recommendations look just like the screening recommendations for prediabetes, so we won’t spend more time on them. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Classification and diagnosis of diabetes. Diabetes Care 2016; 39 (Suppl. 1): S13-S22 40

Recommendations: Screening for Type 2 Diabetes (2)
FPG, 2-h PG after 75-g OGTT, and the A1C are equally appropriate. B In patients with diabetes, identify and, if appropriate, treat other CVD risk factors. B Consider testing for T2DM in overweight/obese children and adolescents with 2 or more add’l diabetes risk factors. E And slide two of the screening recommendations for type 2 diabetes, again just like those for prediabetes. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Classification and diagnosis of diabetes. Diabetes Care 2016; 39 (Suppl. 1): S13-S22 41

Criteria for Testing for T2DM in Children & Adolescents
Overweight plus any 2 : Family history of type 2 diabetes in 1st or 2nd degree relative Race/ethnicity Signs of insulin resistance or conditions associated with insulin resistance Maternal history of diabetes or GDM Age of initiation 10 years or at onset of puberty Frequency: every 3 years Screen with A1C The Association recommends screening for type 2 diabetes or prediabetes in asymptomatic children and adolescents when they meet the criteria of overweight plus any two additional risk factors, including: • Family history of type 2 diabetes in first- or second-degree relative; • Race/ethnicity (Native American, African American, Latino, Asian American, Pacific Islander); • Signs of insulin resistance or conditions associated with insulin resistance, such as acanthosis nigricans, hypertension, dyslipidemia, polycystic ovary syndrome, or small-for-gestational-age birth weight; • Maternal history of diabetes or GDM during the child’s gestation; [CLICK] Begin testing either at puberty or at age 10, whichever comes first; and test every 3 years after that. [CLICK] The American Diabetes Association acknowledges the limited data supporting A1C for diagnosing diabetes in children and adolescents. However, aside from rare instances, such as cystic fibrosis and hemoglobinopathies, ADA continues to recommend A1C in this cohort. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Classification and diagnosis of diabetes. Diabetes Care 2016; 39 (Suppl. 1): S13-S22 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1): S17–S18 Imperatore G, Boyle JP, Thompson TJ, et al.; SEARCH for Diabetes in Youth Study Group. Projections of type 1 and type 2 diabetes burden in the U.S. population aged <20 years through 2050: dynamic modeling of incidence, mortality, and population growth. Diabetes Care 2012;35:2515–2520 American Diabetes Association. Type 2 diabetes in children and adolescents. Diabetes Care 2000;23:381–389 Kester LM, Hey H, Hannon TS. Using hemoglobin A1c for prediabetes and diabetes diagnosis in adolescents: can adult recommendations be upheld for pediatric use? J Adolesc Health 2012;50:321–323 Wu EL, Kazzi NG, Lee JM. Cost effectiveness of screening strategies for identifying pediatric diabetes mellitus and dysglycemia. JAMA Pediatr 2013;167:32–39 42

Recommendations: Detection and Diagnosis of GDM
Test for undiagnosed T2DM at the 1st prenatal visit in those with risk factors. B Test for GDM at 24–28 weeks of gestation in women not previously known to have diabetes. A Screen women with GDM for persistent diabetes at 6–12 weeks postpartum, using the OGTT. E Recommendations for the detection and diagnosis of gestational diabetes mellitus (GDM) are summarized on two slides; First, because of the number of pregnant women with undiagnosed type 2 diabetes, it is reasonable to test women with risk factors for type 2 at the first prenatal visit, using standard diagnostic criteria. [CLICK] Test for GDM at 24–28 weeks of gestation in pregnant women not previously known to have diabetes. [CLICK] Screen women with GDM for persistent diabetes at 6–12 weeks postpartum, using the OGTT and clinically appropriate nonpregnancy diagnostic criteria. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Classification and diagnosis of diabetes. Diabetes Care 2016; 39 (Suppl. 1): S13-S22 References Lawrence JM, Contreras R, Chen W, Sacks DA. Trends in the prevalence of preexisting diabetes and gestational diabetes mellitus among a racially/ethnically diverse population of pregnant women, Diabetes Care 2008;31:899–904 American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S18 43

Recommendations: Detection and Diagnosis of GDM (2)
Women with GDM history should have lifelong screening for development of diabetes or prediabetes at least every 3 years. B Women with GDM history found to have prediabetes should receive lifestyle interventions or metformin to prevent diabetes. A And finally, Women with a history of GDM should have lifelong screening for the development of diabetes or prediabetes at least every 3 years. [CLICK] Women with a history of GDM found to have prediabetes should receive lifestyle interventions or metformin to prevent diabetes. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Classification and diagnosis of diabetes. Diabetes Care 2016; 39 (Suppl. 1): S13-S22 References Lawrence JM, Contreras R, Chen W, Sacks DA. Trends in the prevalence of preexisting diabetes and gestational diabetes mellitus among a racially/ethnically diverse population of pregnant women, 1999–2005. Diabetes Care 2008;31:899–904 American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S15–S16 44

Screening for & Diagnosis of GDM
Gestational diabetes diagnosis can be accomplished with either of two strategies, which we’ll walk through next. [SLIDE] 45

One-Step Strategy At weeks gestation in women not previously dx’d with overt diabetes 75-g OGTT; Measure plasma glucose at fasting and at 1 and 2 hours. GDM dx’d when plasma glucose exceeds: Fasting: 92 mg/dL (5.1 mmol/L) 1 h: 180 mg/dL (10.0 mmol/L) 2 h: 153 mg/dL (8.5 mmol/L) First, the one-step strategy, which consists of a 75g OGTT. In women between 24 and 28 weeks gestation not previously diagnosed with overt diabetes, perform a 75-g OGTT in the morning after an overnight fast of at least 8 hours. Measure plasma glucose measurement fasting and at 1 and 2 hours. Gestational diabetes is diagnosed if the fasting glucose is higher than 92 mg per dL, if the 1 hour glucose is higher than 180, or if the 2 hour is over 153. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Classification and diagnosis of diabetes. Diabetes Care 2016; 39 (Suppl. 1): S13-S22 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S19; Table 6 Metzger BE, Lowe LP, Dyer AR, et al, for the HAPO Study Cooperative Research Group. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med 2008;358:1991–2002 Metzger BE, Gabbe SG, Persson B, et al, for the International Association of Diabetes and Pregnancy Study Groups Consensus Panel. International Association of Diabetes and Pregnancy Study Groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care 2010;33:676–682 46

Two-step Strategy Step 1:
In women not previously dx’d with overt diabetes, perform 50-g GLT (nonfasting); Measure plasma glucose at 1 hour. If 1 hour plasma glucose level is ≥140 mg/dL* (7.8 mmol/L), proceed to step 2. And here’s the 2-step strategy recommended by NIH. First, perform a 50-g GLT (nonfasting), with plasma glucose measurement at 1 h, at 24–28 weeks of gestation in women not previously diagnosed with overt diabetes If the plasma glucose level measured 1 h after the load is ≥140 mg/dL, proceed to Step 2, the 100-g OGTT It’s worth noting here also that the American College of Obstetricians and Gynecologists (ACOG) recommends a lower threshold of 135 in high-risk ethnic minorities with higher prevalence of GDM. [SLIDE] *ACOG recommends 135 mg/dL in high-risk ethnic minorities with higher prevalence of GDM. American Diabetes Association Standards of Medical Care in Diabetes. Classification and diagnosis of diabetes. Diabetes Care 2016; 39 (Suppl. 1): S13-S22 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S19; Table 6 Vandorsten JP, Dodson WC, Espeland MA, et al. NIH consensus development conference: diagnosing gestational diabetes mellitus. NIH Consens State Sci Statements 2013;29:1–31 47

Two-step Strategy (2) Step 2: 100-g OGTT is performed while patient is fasting. The diagnosis of GDM is made if 2 or more of the following plasma glucose levels are met or exceeded: Carpenter/Coustan or NDDG Fasting 95 mg/dL (5.3 mmol/L) 105 mg/dL (5.8 mmol/L) 1h 180 md/dL (10.0 mmol/L) 190 mg/dL (10.6 mmol/L) 2h 155 mg/dL (8.6 mmol/L) 165 mg/dL (9.2 mmol/L) 3h 140 mg/dL (7.8 mmol/L) 145 mg/dL (8.0 mmol/L) If the non-fasted 1-hour glucose is 140 or above, then perform the 100-g OGTT. This one is fasting, and GDM is diagnosed if at least two of the following four criteria are met or exceeded. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Classification and diagnosis of diabetes. Diabetes Care 2016; 39 (Suppl. 1): S13-S22 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S19; Table 6 Vandorsten JP, Dodson WC, Espeland MA, et al. NIH consensus development conference: diagnosing gestational diabetes mellitus. NIH Consens State Sci Statements 2013;29:1–31 48

Recommendations: Monogenic Diabetes Syndromes
All children diagnosed with diabetes in the first 6 months of life should have genetic testing. B Consider Maturity-Onset Diabetes of the Young (MODY) in patients who have mild stable fasting hyperglycemia and multiple family members with diabetes not characteristic of type 1 or type 2. E Consider referring individuals with diabetes that is not typical of type 1 or type 2 diabetes and occurs in successive generations to a specialist for further evaluation. E The Association has added additional guidance, recommendations, and text on monogenic diabetes syndromes for In sum, all children diagnosed with diabetes in the first six months of life should have genetic testing. Consider MODY in individuals with mild stable fasting hyperglycemia and multiple family members with diabetes that is not characteristic of type 1 or type 2. And because a MODY diagnosis can affect therapy and help identify other affected family members, consider referring patients with atypical diabetes occurring in successive generations to a specialist for further evaluation. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Classification and diagnosis of diabetes. Diabetes Care 2016; 39 (Suppl. 1): S13-S22 49

Recommendations: Cystic Fibrosis–Related Diabetes (CFRD)
Annual screening for CFRD with OGTT should begin by age 10 years in all patients with cystic fibrosis who do not have CFRD. B A1C is not recommended as a screening test for CFRD. B For patients with cystic fibrosis and IGT without confirmed diabetes, consider prandial insulin therapy to maintain weight. B Cystic Fibrosis Related Diabetes is the most common comorbidity in people with cystic fibrosis, occurring in about 20% of adolescents and 40-50% of adults. Diabetes in this population, compared to individuals with type 1 or type 2 diabetes, is associated with worse nutritional status, more severe inflammatory lung disease, and greater mortality. Recommendations for the care of patients with cystic-fibrosis-related diabetes (CFRD) are summarized on two slides. First, annual screening for CFRD with OGTT should begin by age 10 years in all patients with cystic fibrosis who do not have CFRD (B); A1C as a screening test is not recommended (B) For patients with cystic fibrosis and IGT but without confirmed diabetes, consider prandial insulin therapy to maintain weight. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Classification and diagnosis of diabetes. Diabetes Care 2016; 39 (Suppl. 1): S13-S22 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S56 Kern AS, Prestridge AL. Improving screening for cystic fibrosis-related diabetes at a pediatric cystic fibrosis program. Pediatrics 2013;132:e512–e518 Waugh N, Royle P, Craigie I, et al. Screening for cystic fibrosis-related diabetes: a systematic review. Health Technol Assess 2012;16:iii–iv, 1–179 Moran A, Dunitz J, Nathan B, Saeed A, Holme B, Thomas W. Cystic fibrosis-related diabetes: current trends in prevalence, incidence, and mortality. Diabetes Care 2009;32:1626–1631 50

Recommendations: Cystic Fibrosis–Related Diabetes (CFRD) (2)
Patients with CFRD should be treated with insulin to attain individualized glycemic goals. A Annual monitoring for complications of diabetes is recommended, starting 5 years after CFRD diagnosis. E See also: “Clinical Care Guidelines for Cystic Fibrosis–Related Diabetes” at Care.Diabetes.org. Patients with CFRD should be treated with insulin to attain individualized glycemic goals (A) Annual monitoring for complications of diabetes is recommended, beginning 5 years after the diagnosis of CFRD (E) The Association has a position statement that provides more detailed guidance on CFRD, “Clinical Care Guidelines for Cystic Fibrosis–Related Diabetes: A Position Statement of the American Diabetes Association and a Clinical Practice Guideline of the Cystic Fibrosis Foundation, Endorsed by the Pediatric Endocrine Society” [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Classification and diagnosis of diabetes. Diabetes Care 2016; 39 (Suppl. 1): S13-S22 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S56 Onady GM, Stolfi A. Insulin and oral agents for managing cystic fibrosis-related diabetes. Cochrane Database Syst Rev 2013;(7):CD004730 Moran A, Brunzell C, Cohen RC, et al. CFRD Guidelines Committee. Clinical care guidelines for cystic fibrosis-related diabetes: a position statement of the American Diabetes Association and a clinical practice guideline of the Cystic Fibrosis Foundation, endorsed by the Pediatric Endocrine Society. Diabetes Care 2010;33:2697–2708 51

Foundations of Care and Comprehensive Medical Evaluation
The Association made some changes to section 3 this year. In 2015 this section was called The Initial Evaluation. For 2016 this section has been combined with section 4. Foundations of Care to make one section that better reflects the importance of integrating clinical evaluation, patient engagement, and ongoing care and highlighting the importance of lifestyle and behavioral modification. The nutrition and vaccination recommendations were streamlined to focus on those aspects of care most important and most relevant to people with diabetes. [SLIDE] 52

Foundations of Care Self Management Education Nutrition Counseling
Physical Activity Smoking Cessation Immunizations Psychosocial Care Medications The foundations of care include eight key components: Self-management education, nutrition, counseling, physical activity, smoking cessation, immunizations, psychosocial care, and medications, which are covered in other chapters. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 53

Foundations of Care Health care providers must take a holistic approach. Team approach facilitates comprehensive assessment and development of a diabetes management plan that fits the patient. Comprehensive clinical evaluation Patient engagement – Chronic Care Model Optimal diabetes management starts with laying down the foundations of care. Health care providers must take a holistic approach in providing care, taking into account all aspects of the patient’s life circumstances. A team approach to diabetes management facilities a comprehensive assessment and development of a plan that addresses the patient’s values and circumstances. The investment of time and collaboration can facilitate, and potentially expedite, care delivery and achieve and maintain outcomes. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 54

Basis for Initial Care Diabetes Self-Management Education (DSME)
Diabetes Self-Management Support (DSMS) Medical Nutrition Therapy (MNT) Physical activity education Smoking cessation counseling Guidance on routine immunizations Psychosocial care Diabetes Self-Management Education, Diabetes Self-Management Support, Medical Nutrition Therapy, counseling on smoking cessation, education on physical activity, guidance on routine immunizations, and psychosocial care are the cornerstone of diabetes management. Patients should be referred for such services if not readily available in the clinical care setting. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 55

Recommendations: Diabetes Self-Management Education & Support
All people with diabetes should participate in DSME and DSMS both at diagnosis and as needed thereafter. B Effective self-management, improved clinical outcomes, health status, and quality-of-life are key outcomes of DSME and DSMS and should be measured and monitored as part of care. C DSME/S should be patient-centered, respectful, and responsive to individual patient preferences, needs, and values that should guide clinical decisions. A Here are the recommendations on diabetes self management education and support. In accordance with the National Standards for Diabetes Self-Management Education and Support, the Association recommends that all people with diabetes should participate in DSME, to facilitate knowledge, skill, and ability necessary for diabetes self-care, and DSMS, to assist with implementing and sustaining skills and behaviors needed for on-going self-management, both at diagnosis and as needed thereafter. [CLICK] Effective self-management, improved clinical outcomes, health status, and quality-of-life are key outcomes of DSME and DSMS and should be measured and monitored as part of care. [CLICK] DSME and DSMS should be patient-centered, respectful, and responsive to individual patient preferences, needs, and values that should guide clinical decisions [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 56

Recommendations: Diabetes Self-Management Education & Support (2)
DSME/S programs may have the necessary elements in their curricula that are needed to prevent the onset of diabetes; content should be tailored specifically when prevention of diabetes is the desired goal. B Because DSME and DSMS can result in cost-savings and improved outcomes B, DSME and DSMS should be adequately reimbursed by third-party payers. E DSME/S programs may have the necessary elements in their curricula that are needed to prevent the onset of diabetes. DSME/S programs should therefore tailor their content specifically when prevention of diabetes is the desired goal. [CLICK] And finally, because DSME and DSMS can result in cost-savings and improved outcomes, both should be adequately reimbursed by third-party payers. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 57

DSME / DSMS Delivery Four critical time points for DSME/S delivery:
At diagnosis Annually for assessment of education, nutrition, and emotional needs When new complicating factors arise that influence self-management; and When transitions in care occur The DSME/S algorithm defines four critical time points for DSME/S delivery. These include 1) at diagnosis; 2) annually for assessment of education, nutrition, and emotional needs; 3) when new complicating factors arise that influence self-management; and 4) when transitions in care occur [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 58

Goals of Medical Nutrition Therapy (MNT)
Promote healthful eating patterns, eating a variety of nutrient-dense foods in appropriate portion sizes, to improve overall health and to: Achieve and maintain body weight goals Attain individualized glycemic, blood pressure, and lipid goals Delay or prevent complications of diabetes Address nutrition needs based on personal & cultural preferences, health literacy & numeracy, access to healthful foods, willingness and ability to make behavioral changes & barriers to change. Figuring out what to eat can be the most challenging part of daily self-management for people with diabetes. The Association has long held that there is no “one size fits all” approach to medical nutrition therapy, and lays out four goals for MNT for adults with diabetes: 1. We want to promote and support healthful eating patterns, emphasizing a variety of nutrient-dense foods in appropriate portion sizes, in order to improve overall health and specifically to: Achieve and maintain body weight goals Attain individualized glycemic, blood pressure, and lipid goals Delay or prevent complications of diabetes [CLICK] To address individual nutrition needs based on personal and cultural preferences, health literacy and numeracy, access to healthful foods, willingness and ability to make behavioral changes, and barriers to change. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 59

Goals of Medical Nutrition Therapy (2)
To maintain the pleasure of eating by providing non-judgmental messages about food choices. Provide practical tools for developing healthful eating patterns rather than focusing on individual macronutrients, micro-nutrients, or single foods. Third, we want to help our patients maintain the pleasure of eating by providing non- judgmental messages about food choices, and finally, [CLICK] we want to provide the individual with diabetes with practical tools for developing healthful eating patterns rather than focusing on individual macronutrients, micro-nutrients, or single foods. [SLIDE} American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 60

Recommendations: Nutrition
Effectiveness of Nutrition Therapy: An individualized MNT program is recommended for all people with type 1 and type 2 diabetes. A For people with T1DM or those with T2D who are on a flexible insulin program, education on carb counting or estimation. A For patients on a fixed insulin program, having a consistent pattern of carbohydrate intake with respect to time and amount can result in improved glycemic control and a reduced risk of hypoglycemia. B Moving on to recommendations in the area of nutrition therapy, first, an individualized medical nutrition therapy program, preferably provided by a registered dietitian, is recommended for al patients with type 1 and type 2 diabetes. For people with type 1 diabetes or type 2 who are prescribed a flexible insulin therapy program, education carb counting or estimation to determine mealtime insulin dosing is recommended as it can improve glycemic control. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 61

Recommendations: Nutrition (2)
Effectiveness of Nutrition Therapy (2): Emphasizing healthy food choices and portion control may be more helpful for those with type 2 diabetes who are not taking insulin, who have limited health literacy or numeracy, and who are elderly and prone to hypoglycemia. C Because diabetes nutrition therapy can result in cost savings B and improved outcomes (e.g., A1C reduction) A, MNT should be adequately reimbursed by insurance and other payers. E And the final points under the effectiveness of nutrition therapy: For your patients with type 2 diabetes who are not on insulin who have limited health literacy or are elderly and prone to hypoglycemia, it may make more sense to simply emphasize healthy food choices and portion control. And finally, because diabetes nutrition therapy can result in cost savings and improved outcomes (e.g., A1C reduction), MNT should be adequately reimbursed by insurance and other payers. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 62

Energy Balance: Modest weight loss achievable by the combination of lifestyle modification and the reduction of energy intake benefits overweight or obese adults with type 2 diabetes and also those at risk for diabetes. Interventional programs to facilitate this process are recommended. A As far as energy balance, overweight or obese adults with type 2 diabetes benefit from modest weight loss with a weight loss target of 5-7% of total body weight. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 63

Eating patterns & macronutrient distribution: Macronutrient distribution should be individualized while keeping total calorie and metabolic goals in mind. E Carbohydrate intake from whole grains, vegetables, fruits, legumes, and dairy products, with an emphasis on foods higher in fiber and lower in glycemic load, should be advised over other sources, especially those containing sugars. B Moving on to eating patterns and macronutrient distribution, because there is no single ideal dietary distribution of calories among carbohydrates, fats, and proteins for people with diabetes, macronutrient distribution should be individualized while keeping total calorie and metabolic goals in mind. And encourage patients to consume more whole grains, vegetables, fruits, legumes, and dairy products, with an emphasis on foods higher in fiber and lower in glycemic load, over carbs from other sources, especially those containing sugars. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 64

Eating patterns & macronutrient distribution (2): People with diabetes and those at risk should avoid sugar-sweetened beverages to control weight and reduce their risk for CVD and fatty liver B and should minimize the consumption of sucrose-containing foods that have the capacity to displace healthier, more nutrient- dense food choices. A And finally under eating patterns, your patients with and at risk for diabetes are advised to avoid sugar-sweetened beverages in order to control weight and reduce their risk for cardiovascular disease and fatty liver and should minimize the consumption of sucrose- containing foods that could to displace healthier, more nutrient-dense food choices. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 65

Protein: In individuals with type 2 diabetes, ingested protein appears to increase insulin response without increasing plasma glucose concentrations. Therefore, carbohydrate sources high in protein should not be used to treat or prevent hypoglycemia. B As far as protein is concerned, for your patients with type 2 diabetes it is recommended that they not use carbohydrate sources high in protein to treat low blood sugars. This is because in type 2 diabetes, ingested protein appears to increase insulin response without increasing plasma glucose concentrations. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 66

Dietary Fat: An eating plan emphasizing elements of a Mediterranean-style diet rich in monounsaturated fats may improve glucose metabolism and lower CVD risk and can be an effective alternative to a low-fat, high-carb diet. B Eating foods containing long-chain omega-3 fatty acids and omega-3 linolenic acid (ALA) is recommended to prevent or treat CVD B; however, evidence does not support a beneficial role for omega-3 supplements. A The data on ideal total dietary fat intake is inconclusive but an eating plan emphasizing elements of a Mediterranean-style diet rich in monounsaturated fats may improve glucose metabolism and lower CVD risk and can be an effective alternative to a diet low in total fat but relatively high in carbohydrates. Eating foods containing long-chain omega-3 fatty acids (EPA and DHA), such as fatty fish, and omega-3 linolenic acid (ALA) is recommended to prevent or treat CVD; however, evidence does not support a beneficial role for omega-3 supplements. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 67

Micronutrients and herbal supplements: There is no clear evidence that dietary supplementation with vitamins, minerals, herbs, or spices can improve diabetes, and there may be safety concerns regarding the long-term use of antioxidant supplements such as vitamins E and C and carotene. C As far as micronutrients and herbal supplements, the Association maintains the position that there is no clear evidence of benefit to glycemic control, and there may be safety concerns regarding long-term use of antioxidant supplements such as vitamins C and E, and carotene. At the very least, encourage your patients to fully list or disclose on their medical history forms any herbal supplements or micronutrients they may be taking. Patients tend to overlook these supplements since they’re not prescribed; they may not think they “count.” [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 68

Alcohol: Adults with diabetes should drink alcohol only in moderation (no more than one drink per day for adult women and no more than two drinks per day for adult men). C Alcohol consumption may place people with diabetes at an increased risk for delayed hypoglycemia, especially if taking insulin or insulin secretagogues. Education and awareness regarding the recognition and management of delayed hypoglycemia are warranted. B Adults with diabetes who drink alcohol should do so in moderation, which is defined as no more than one drink per day for adult women and no more than two drinks per day for adult men. And because alcohol consumption may place people with diabetes at an increased risk for delayed hypoglycemia, it’s important that they are well able to recognize and manage delayed hypoglycemia. For your patients who are less aware of hypoglycemia, it may make sense to recommend that they avoid alcohol entirely. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 69

Sodium: As for the general population, people with diabetes should limit sodium consumption to less than 2,300 mg/day, although further restriction may be indicated for those with both diabetes and hypertension. B And finally, sodium. As with recommendations for the general population, people with diabetes should limit sodium consumption to less than 2,300 mg/day, although further restriction may be indicated for those with both diabetes and hypertension. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 70

Recommendations: Physical Activity
Children with diabetes/prediabetes: at least 60 min/day physical activity B Adults with diabetes: at least 150 min/wk of moderate-intensity aerobic activity over at least 3 days/week with no more than 2 consecutive days without exercise A All individuals, including those with diabetes, should reduce sedentary time, particularly by breaking up extended amounts of time (>90 min) spent sitting. B Adults with type 2 diabetes should perform resistance training at least twice weekly A Recommendations for physical activity for people with diabetes1 are summarized on this slide • As with all children, children with diabetes or prediabetes should be encouraged to engage in at least 60 minutes of physical activity each day. [CLICK] Adults with diabetes should be advised to perform at least 150 min/week of moderate- intensity aerobic physical activity (with “moderate” defined as 50–70% of maximum heart rate), spread over at least 3 days/week with no more than 2 consecutive days without exercise. [CLICK] All individuals, including those with diabetes, should be encouraged to reduce sedentary time, particularly by breaking up extended amounts of time (>90 min) spent sitting. [CLICK] And finally, in the absence of contraindications, adults with type 2 diabetes should be encouraged to perform resistance training at least twice per week. [CLICK] [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S31 Knowler WC, Barrett-Connor E, Fowler SE, et al, for the Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002;346:393–403 Tuomilehto J, Lindström J, Eriksson JG, et al.; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med 2001;344:1343–1350 Pan XR, Li GW, Hu YH, et al. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care 1997;20:537–544 Colberg SR, Sigal RJ, Fernhall B, et al. Exercise and type 2 diabetes. The American Collegoe of Sports Medicine and the American Diabetes Association: joint position statement. Diabetes Care 2010;33:2692–2696 71

Recommendations: Smoking Cessation
Advise all patients not to use cigarettes, other tobacco products, or e-cigarettes. A Include smoking cessation counseling and other forms of treatment as a routine component of diabetes care. B The Association offers two key recommendations in the areas of tobacco and e-cigarettes. First, do advise all patients not to use cigarettes, other tobacco products, or e-cigarettes. This last one – e-cigarettes– is hard, but there just are no rigorous studies demonstrating that e- cigarettes are a healthier alternative to smoking or that e-cigarettes can facilitate smoking cessation. More extensive research of their short- and long-term effects is needed to determine their safety and their cardiopulmonary effects in comparison with smoking and standard approaches to smoking cessation so the Association recommends against their use. [CLICK] And secondly, do include smoking cessation counseling and other forms of treatment as a routine component of diabetes care. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 72

Recommendations: Immunizations
Provide routine vaccinations for children and adults with diabetes per age-specific CDC recommendations. C CDC.gov/vaccines Administer Hepatitis B vaccine to unvaccinated adults with diabetes aged years. C Consider administering hepatitis B vaccine to unvaccinated adults with diabetes ≥ 60 years old. C As far as immunizations, the Association recommends that, as for the general population, all children and adults with diabetes should receive routine vaccinations according to age-specific CDC recommendations, which you can download at CDC/vaccines. These recommendations include both flu and pneumococcal pneumonia vaccines. [CLICK] And finally, people with diabetes have higher rates of hepatitis B than the general population, perhaps due to contact with infected blood or through improper equipment use. Thus, due to the higher likelihood of transmission, hepatitis B vaccine is recommended for adults with diabetes. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 73

Recommendations: Psychosocial Care
Address the patient’s psychological and social situation in medical management of diabetes. B Psychosocial screening and follow-up include, but are not limited to: Attitudes Expectations for medical mgmt. & outcomes Affect/mood Quality-of-life Resources- financial, social & emotional Psychiatric history E Emotional well-being is an important part of diabetes care and self-management. Psychological and social problems can impair the individual’s or family’s ability to carry out diabetes care tasks and therefore compromise health status. The Association offers several recommendations for addressing psychosocial issues, comprised on the next two slides. First, the patient’s psychological and social situation should be addressed within the context of the medical management of diabetes. Psychosocial screening and follow-up may include, but are not limited to, attitudes about the illness, expectations for medical management and outcomes, affect/mood, general and diabetes-related quality-of-life, resources (financial, social, and emotional), and psychiatric history. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 74

Recommendations: Psychosocial Care (2)
Routinely screen for depression, diabetes-related distress, anxiety, eating disorders & cognitive impairment. B Adults aged ≥65 years with DM should be considered for evaluation of cognitive function, depression screening and treatment. B Patients with diabetes and depression should receive a collaborative care approach for depression mgmt. A Routinely screen for psychosocial problems such as depression, diabetes-related distress, anxiety, eating disorders, and cognitive impairment. [CLICK] Older adults (aged ≥65 years) with diabetes should be considered for evaluation of cognitive function, depression screening and treatment. [CLICK] And finally, Patients with comorbid diabetes and depression should receive a stepwise collaborative care approach for the management of depression. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 75

Comprehensive Medical Evaluation
A complete medical evaluation should be performed at the initial visit to: Confirm & classify diagnosis B Detect complications & potential comorbid conditions E Review prior treatment & risk factor control E Begin formulation of care management plan B Develop a continuing care plan B Moving on to the medical evaluation, a comprehensive medical evaluation should be performed at the initial visit in order to accomplish several things: First, to confirm the diagnosis and classify diabetes; [CLICK] To detect any potential diabetes complications and potential comorbid conditions; [CLICK] In patients with established diabetes, to review previous treatment and risk factor control; [CLICK] To Begin patient engagement in the formulation of a care management plan, and finally, [CLICK] To develop a continuing care plan [SLIDE[ American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 76

Components of the Comprehensive Diabetes Evaluation
Medical history: Age and characteristics of onset of diabetes Eating patterns, nutritional status, weight history, physical activity habits, nutrition education and behavioral support history and needs Presence of common comorbidities, psychosocial problems, and dental disease Screen for depression, diabetes distress History of smoking, alcohol consumption, and substance use A focus on the components of comprehensive diabetes evaluation will help ensure optimal management of the patient with diabetes. These are outlined on the next several slides. First, medical history, including age and characteristics of onset of diabetes; eating patterns, nutritional status, weight history, physical activity habits, nutrition education and behavioral support history and needs; presence of common comorbidities, psychosocial problems, and dental disease. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S21; Table 7 77

Components of the Comprehensive Diabetes Evaluation (2)
Medical History (2): Diabetes education, self-management, and support history & needs Previous treatment regimens and response to therapy (A1C records) Results of glucose monitoring and patient’s use of data DKA frequency, severity, and cause Hypoglycemia episodes, awareness, frequency & causes The medical history should also include the patient’s history of diabetes education, self- management, and support as well as their needs in each of these areas. Previous treatment regimens and response to therapy; results of glucose monitoring and the patient’s data use; frequency of diabetic ketoacidosis, severity and cause; and hypoglycemic episodes, awareness, frequency and causes. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S21; Table 7 78

Medical History (3): History of increased blood pressure, increased lipids, and tobacco use Microvascular: retinopathy, nephropathy, and neuropathy (sensory, including history of foot lesions; autonomic, including sexual dysfunction and gastroparesis) Macrovascular: coronary heart disease, cerebrovascular disease, and peripheral arterial disease And the final components of the medical history-- the patient’s history of high blood pressure, abnormal lipids, and any tobacco use; and any history of micro- or macrovascular complications, being certain to include sexual dysfunction. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S21; Table 7 79

Physical Examination: Height, weight, and BMI; growth and pubertal development in children and adolescents Blood pressure determination, including orthostatic measurements when indicated Fundoscopic examination Thyroid palpation Skin examination Comprehensive foot examination Moving on to the physical exam, which should include height, weight and BMI. In children and adolescents you should also track growth and pubertal development. Blood pressure determination, an eye exam, thyroid palpation, skin exam– looking for acanthosis nigricans or injection or infusion sites; and the comprehensive foot exam. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 80

Laboratory Evaluation A1C, if results not available within past 3 months If not performed/available within past year: Fasting lipid profile Liver function tests Spot urine albumin-to-creatinine ratio Serum creatinine and eGFR Thyroid-stimulating hormone in patients with type 1 diabetes or dyslipidemia or women aged >50 years And finally, the last components of the comprehensive exam, the laboratory evaluation. Perform an A1C if results are not available from within the past 3 months. And the rest of these if you don’t have them from within the past year: a fasting lipid profile, liver function tests, spot urine albumin-to-creatinine ratio, serum creatinine and estimated glomerular filtration rate, and, finally, in patients with type 1 or dyslipidemia, or women over age 50, get a thyroid stimulating hormone. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Foundations of care and the comprehensive medical evaluation. Diabetes Care 2016; 39 (Suppl. 1): S23-S35 81

Prevention or Delay of Type 2 Diabetes
Now we are going to move on to section four, on the prevention or delay of type 2 diabetes. [SLIDE] 82

Recommendations: Prevention or Delay of T2DM
Patients with prediabetes should be referred to an intensive diet and physical activity behavioral counseling program adhering to the tenets of the DPP targeting a loss of 7% of body weight, and should increase their moderate physical activity to at least 150 min/week. A Offer follow-up counseling and maintenance programs for long-term success in preventing diabetes. B First, patients with prediabetes should be referred to an intensive diet and physical activity behavioral counseling program that adheres to the tenets of the Diabetes Prevention Program. It should target a weight loss of 7% and should increase physical activity to at least 150 minutes/ week of moderate activity. Again, this equivalent to a brisk walk, but basically you just want their heart rate up to 50-70% of max. Offer follow-up counseling and maintenance programs to encourage adherence and promote long-term success in preventing type 2 diabetes. [SLIDE] References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S20 Knowler WC, Barrett-Connor E, Fowler SE,et al. Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002;346:393–403 Tuomilehto J, Lindström J, Eriksson JG, et al. Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med 2001;344:1343–1350 Pan XR, Li GW, Hu YH, et al. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care 1997;20:537–544 Buchanan TA, Xiang AH, Peters RK, et al. Preservation of pancreatic beta-cell function and prevention of type 2 diabetes by pharmacological treatment of insulin resistance in high-risk Hispanic women. Diabetes 2002;51:2796–2803 Chiasson JL, Josse RG, Gomis R, Hanefeld M, Karasik A, Laakso M; STOP-NIDDM Trial Research Group. Acarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM randomised trial. Lancet 2002; 359:2072–2077 Gerstein HC, Yusuf S, Bosch J, et al.; DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) Trial Investigators. Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled trial. Lancet 2006;368:1096–1105 Ramachandran A, Snehalatha C, Mary S, Mukesh B, Bhaskar AD, Vijay V; Indian Diabetes Prevention Programme (IDPP) The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1). Diabetologia 2006;49:289–297 American Diabetes Association Standards of Medical Care in Diabetes. Prevention or delay of type 2 diabetes. Diabetes Care 2016; 39 (Suppl. 1): S36-S38 83

Recommendations: Prevention or Delay of T2DM (2)
Based on cost-effectiveness of diabetes prevention, such programs should be covered by third-party payers. B Metformin therapy for prevention of type 2 diabetes should be considered in those with prediabetes, especially for those with BMI >35 kg/m2, aged < 60 years, and women with prior gestational diabetes (GDM). A Many studies have shown that diabetes prevention is cost effective, so the Association maintains that such programs should be covered by third party payers. Consider metformin in your patients with prediabetes, especially in those with BMIs over 35, who are younger than 60 years old, and women with a history of gestational diabetes. [SLIDE] References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S20 Knowler WC, Barrett-Connor E, Fowler SE,et al. Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002;346:393–403 Tuomilehto J, Lindström J, Eriksson JG, et al. Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med 2001;344:1343–1350 Pan XR, Li GW, Hu YH, et al. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care 1997;20:537–544 Buchanan TA, Xiang AH, Peters RK, et al. Preservation of pancreatic beta-cell function and prevention of type 2 diabetes by pharmacological treatment of insulin resistance in high-risk Hispanic women. Diabetes 2002;51:2796–2803 Chiasson JL, Josse RG, Gomis R, Hanefeld M, Karasik A, Laakso M; STOP-NIDDM Trial Research Group. Acarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM randomised trial. Lancet 2002; 359:2072–2077 Gerstein HC, Yusuf S, Bosch J, et al.; DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) Trial Investigators. Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled trial. Lancet 2006;368:1096–1105 Ramachandran A, Snehalatha C, Mary S, Mukesh B, Bhaskar AD, Vijay V; Indian Diabetes Prevention Programme (IDPP) The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1). Diabetologia 2006;49:289–297 American Diabetes Association Standards of Medical Care in Diabetes. Prevention or delay of type 2 diabetes. Diabetes Care 2016; 39 (Suppl. 1): S36-S38 84

Monitor at least annually for the development of diabetes in those with prediabetes. E Screening for and treatment of modifiable risk factors for CVD is suggested. B Monitor at least annually for the development of diabetes in those with prediabetes, and it’s also recommended that you screen for and treat modifiable risk factors for cardiovascular disease, as indicated. [SLIDE] References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S20 Knowler WC, Barrett-Connor E, Fowler SE,et al. Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002;346:393–403 Tuomilehto J, Lindström J, Eriksson JG, et al. Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med 2001;344:1343–1350 Pan XR, Li GW, Hu YH, et al. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care 1997;20:537–544 Buchanan TA, Xiang AH, Peters RK, et al. Preservation of pancreatic beta-cell function and prevention of type 2 diabetes by pharmacological treatment of insulin resistance in high-risk Hispanic women. Diabetes 2002;51:2796–2803 Chiasson JL, Josse RG, Gomis R, Hanefeld M, Karasik A, Laakso M; STOP-NIDDM Trial Research Group. Acarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM randomised trial. Lancet 2002; 359:2072–2077 Gerstein HC, Yusuf S, Bosch J, et al.; DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) Trial Investigators. Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled trial. Lancet 2006;368:1096–1105 Ramachandran A, Snehalatha C, Mary S, Mukesh B, Bhaskar AD, Vijay V; Indian Diabetes Prevention Programme (IDPP) The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1). Diabetologia 2006;49:289–297 American Diabetes Association Standards of Medical Care in Diabetes. Prevention or delay of type 2 diabetes. Diabetes Care 2016; 39 (Suppl. 1): S36-S38 85

DSME and DSMS programs are appropriate for people with prediabetes to receive education and support to develop and maintain behaviors that can prevent or delay the onset of diabetes. B Technology assisted tools can be useful elements of effective lifestyle modification to prevent diabetes. B Both diabetes self-management education and support programs are appropriate venues for people with prediabetes to receive education and support to develop and maintain behaviors that can prevent or delay the onset of diabetes. And finally, technological tools such as online social networks, distance- learning, educational DVDs, and mobile apps can be useful elements of effective lifestyle modification to prevent diabetes. [SLIDE] References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S20 Knowler WC, Barrett-Connor E, Fowler SE,et al. Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002;346:393–403 Tuomilehto J, Lindström J, Eriksson JG, et al. Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med 2001;344:1343–1350 Pan XR, Li GW, Hu YH, et al. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care 1997;20:537–544 Buchanan TA, Xiang AH, Peters RK, et al. Preservation of pancreatic beta-cell function and prevention of type 2 diabetes by pharmacological treatment of insulin resistance in high-risk Hispanic women. Diabetes 2002;51:2796–2803 Chiasson JL, Josse RG, Gomis R, Hanefeld M, Karasik A, Laakso M; STOP-NIDDM Trial Research Group. Acarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM randomised trial. Lancet 2002; 359:2072–2077 Gerstein HC, Yusuf S, Bosch J, et al.; DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) Trial Investigators. Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled trial. Lancet 2006;368:1096–1105 Ramachandran A, Snehalatha C, Mary S, Mukesh B, Bhaskar AD, Vijay V; Indian Diabetes Prevention Programme (IDPP) The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1). Diabetologia 2006;49:289–297 American Diabetes Association Standards of Medical Care in Diabetes. Prevention or delay of type 2 diabetes. Diabetes Care 2016; 39 (Suppl. 1): S36-S38 86

Glycemic Targets Section 5. Glycemic Targets 87

Diabetes Care: Glycemic Control
Two primary techniques available for health providers and patients to assess effectiveness of management plan on glycemic control Patient self-monitoring of blood glucose (SMBG) A1C CGM or interstitial glucose may be a useful adjunct to SMBG in selected patients. In addition to an initial evaluation and management, diabetes care requires an assessment of glycemic control Two primary techniques available for health providers and patients to assess the effectiveness of the management plan on glycemic control are summarized on this slide Patient self-monitoring of blood glucose (SMBG) A1C Continuous Glucose Monitoring or interstitial glucose may be a useful adjunct to SMBD in some patients. Recommendations for glucose monitoring, A1C testing, correlation of A1C with average glucose, glycemic goals in adults, intensive glycemic control and cardiovascular outcomes, and recommended glycemic goals for many nonpregnant adults with diabetes as well as glycemic goals in pregnant women are summarized in the following slides. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Glycemic targets. Diabetes Care 2016; 39 (Suppl. 1): S39-S46 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S21 88

Recommendations: Glucose Monitoring
When prescribed as part of a broader educational context, SMBG results may be helpful to guide treatment decisions and/or patient self-management for patients using less frequent insulin injections B or noninsulin therapies. E When prescribing SMBG, ensure that patients receive ongoing instruction and regular evaluation of SMBG technique and SMBG results, and their ability to use SMBG data to adjust therapy. E When prescribed as part of a broader educational context, SMBG results may be helpful to guide treatment decisions and/or patient self-management for patients using less frequent insulin injections or noninsulin therapies When prescribing SMBG, ensure that patients receive ongoing instruction and regular evaluation of SMBG technique and SMBG results, as well as their ability to use SMBG data to adjust therapy The ongoing need for and frequency of SMBG should be reevaluated at each routine visit [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Glycemic targets. Diabetes Care 2016; 39 (Suppl. 1): S39-S46 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S21–S22 89

Recommendations: Glucose Monitoring (2)
Patients on multiple-dose insulin (MDI) or insulin pump therapy should do SMBG B Prior to meals and snacks At bedtime Prior to exercise When they suspect low blood glucose After treating low blood glucose until they are normoglycemic Prior to critical tasks such as driving Possibly also post-prandially Recommendations for glucose monitoring are summarized on three slides Patients on multiple-dose insulin (MDI) or insulin pump therapy should do SMBG prior to meals and snacks, occasionally postprandially, at bedtime, prior to exercise, when they suspect low blood glucose, after treating low blood glucose until they are normoglycemic, and prior to critical tasks such as driving This may mean testing 6-10 times per day, though individual needs vary. But at least in studies of children with type 1 diabetes, increased daily frequency of SMBG was significantly associated with lower A1C. SMBG frequency and timing should be dictated by the patient’s specific needs and goals SMBG is especially important for patients treated with insulin to monitor for and prevent asymptomatic hypoglycemia and hyperglycemia [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Glycemic targets. Diabetes Care 2016; 39 (Suppl. 1): S39-S46 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S21 90

When used properly, CGM in conjunction with intensive insulin regimens is a useful tool to lower A1C in selected adults (aged ≥ 25 years) with type 1 diabetes. A Although the evidence for A1C lowering is less strong in children, teens, and younger adults, CGM may be helpful in these groups. Success correlates with adherence to ongoing use of the device. B CGM may be a supplemental tool to SMBG in those with hypoglycemia unawareness and/or frequent hypoglycemic episodes. C When used properly, CGM in conjunction with intensive insulin regimens is a useful tool to lower A1C in selected adults with type 1 diabetes Although the evidence for A1C lowering is less strong in children, teens, and younger adults, CGM may be helpful in these groups. Success correlates with adherence to ongoing use of the device. CGM may be a supplemental tool to SMBG in those with hypoglycemia unawareness and/or frequent hypoglycemic episodes [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Glycemic targets. Diabetes Care 2016; 39 (Suppl. 1): S39-S46 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S21–S22 Tamborlane WV, Beck RW, Bode BW, et al for the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med 2008;359:1464–1476 Yeh HC, Brown TT, Maruthur N, et al. Comparative effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus: a systematic review and meta-analysis. Ann Intern Med 2012;157:336–347 91

Given variable adherence to CGM, assess individual readiness for continuing use of CGM prior to prescribing. E When prescribing CGM, robust diabetes education, training, and support are required for optimal CGM implementation and ongoing use. E And finally, due to variable adherence, optimal CGM use requires an assessment of individual readiness for the technology as well as initial and ongoing education and support. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Glycemic targets. Diabetes Care 2016; 39 (Suppl. 1): S39-S46 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S21–S22 Tamborlane WV, Beck RW, Bode BW, et al for the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med 2008;359:1464–1476 Yeh HC, Brown TT, Maruthur N, et al. Comparative effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus: a systematic review and meta-analysis. Ann Intern Med 2012;157:336–347 92

Recommendations: A1C Testing
Perform the A1C test at least 2x annually in patients that meet treatment goals (and have stable glycemic control). E Perform the A1C test quarterly in patients whose therapy has changed or who are not meeting glycemic goals. E Use of point-of-care (POC) testing for A1C provides the opportunity for more timely treatment changes. E A1C reflects average glycemia over several months and has strong predictive value for diabetes complications. Thus, A1C testing should be performed routinely in all patients with diabetes— at initial assessment and as part of continuing care. Measurement about every 3 months determines whether patients’ glycemic targets have been reached and maintained, though the frequency of A1C testing should depend on the clinical situation, the treatment regimen, and the clinician’s judgment. For your patients meeting treatment goals and with stable control, check the A1C at least twice a year, and for your patients whose therapy has changed or who aren’t meeting glycemic goals, test quarterly. You may also have patients who are unstable or highly intensively managed, such as pregnant women with type 1, whom you may wish to test more frequently than every 3 months. Point of care A1C testing can help accommodate more timely decisions, for example on when to change therapy. The A1C test is subject to certain limitations: conditions that affect erythrocyte turnover (e.g., hemolysis, blood loss) and hemoglobin variants must be considered, particularly when the A1C result does not correlate with the patient’s clinical situation;2 in addition, A1C does not provide a measure of glycemic variability or hypoglycemia For patients prone to glycemic variability (especially type 1 diabetic patients, or type 2 diabetic patients with severe insulin deficiency), glycemic control is best judged by the combination of result of self-monitoring of blood glucose (SMBG) testing and A1C The A1C may also confirm the accuracy of a patient’s meter (or the patient’s reported SMBG results) and the adequacy of the SMBG testing schedule [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Glycemic targets. Diabetes Care 2016; 39 (Suppl. 1): S39-S46 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S22–S23 Sacks DB, Arnold M, Bakris GL, et al. National Academy of Clinical Biochemistry. Position statement executive summary: guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Diabetes Care 2011;34:1419–1423 93

Mean Glucose Levels for Specified A1C Levels
Mean Glucose Mean Plasma Glucose* Fasting Premeal Postmeal Bedtime A1C% mg/dL mmol/L 6 126 7.0 <6.5 122 118 144 136 142 139 164 153 7 154 8.6 152 176 177 167 155 189 175 8 183 10.2 8-8.5 178 179 206 222 9 212 11.8 10 240 13.4 11 269 14.9 12 298 16.5 This slide shows the correlation between A1C and mean plasma glucose levels based on data from the international A1C-Derived Average Glucose (ADAG) trial. The trial used frequent SMBG and continuous glucose monitoring in 507 adults with type 1, type 2, and no diabetes. The Association and the American Association for Clinical Chemistry have determined that the correlation (r = 0.92) is strong enough to justify reporting both an A1C result and an estimated average glucose (eAG) results when a clinician orders the A1C test2 For patients in whom A1C/eAG and measured blood glucose appear discrepant, clinicians should consider the possibilities of hemoglobinopathy or altered red cell turnover, and the options of more frequent and/or different timing of SMBG or use of CGM Other measures of chronic glycemia such as fructosamine are available, but their linkage to average glucose and their prognostic significance are not as clear as is the case for A1C [CLICK] You can access a calculator for converting A1C results into eAG, in either mg/dL or mmol/L, at professional.diabetes.org/eAG [SLIDE] professional.diabetes.org/eAG American Diabetes Association Standards of Medical Care in Diabetes. Glycemic targets. Diabetes Care 2016; 39 (Suppl. 1): S39-S46 References Nathan DM, Kuenen J, Borg R, et al for the A1C-Derived Average Glucose Study Group. Translating the A1C assay into estimated average glucose values. Diabetes Care 2008;31:1473–1478 American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S23; Table 8 94

Recommendations: Glycemic Goals in Adults
Lowering A1C to <7% has been shown to reduce microvascular complications and, if implemented soon after the diagnosis of diabetes, is associated with long-term reduction in macrovascular disease. B Consider more stringent goals (e.g. <6.5%) for select patients if achievable without significant hypos or other adverse effects. C Consider less stringent goals (e.g. <8%) for patients with a hx of severe hypoglycemia, limited life expectancy, or other conditions that make <7% difficult to attain. B We’ll discuss glycemic goals in children and adolescents and in pregnant women in the sections specific to care of those populations. These slides are specific to nonpregnant adults. Hyperglycemia defines diabetes, and glycemic control is fundamental to diabetes management; recommendations for glycemic goals in adults1 are reviewed on three slides. The concerning mortality findings in the ACCORD trial, discussed which we’ll get to shortly, and the relatively intense efforts required to achieve near-euglycemia should also be considered when setting glycemic targets. Glycemic control achieved using A1C targets of <7% has been shown to reduce microvascular complications of diabetes and, in type 1 diabetes, mortality. If implemented soon after the diagnosis of diabetes this target is associated with long-term reduction in macrovascular disease. Providers might suggest more stringent A1C goals (such as <6.5%) for selected individual patients if this can be achieved without significant hypoglycemia or other adverse effects of treatment. Appropriate patients might include those with short duration of diabetes, type 2 diabetes treated with lifestyle or metformin only, long life expectancy, or no significant cardiovascular disease. Less stringent A1C goals (such as <8%) may be appropriate for patients with a history of severe hypoglycemia, limited life expectancy, advanced microvascular or macrovascular complications, extensive comorbid conditions, or long-standing diabetes in whom the general goal is difficult to attain despite diabetes self-management education, appropriate glucose monitoring, and effective doses of multiple glucose-lowering agents including insulin. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Glycemic targets. Diabetes Care 2016; 39 (Suppl. 1): S39-S46 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S23 The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977–986 The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group. Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive therapy. N Engl JMed 2000;342:381–389 Martin CL, Albers J, Herman WH, et al for the DCCT/EDIC Research Group. Neuropathy among the diabetes control and complications trial cohort 8 years after trial completion. Diabetes Care 2006;29:340–344 95

A1C and CVD Outcomes DCCT: Lower risk of CVD events with intensive control EDIC: 57% reduction in risk of nonfatal MI, stroke, or CVD death Benefit of intensive glycemic control persists for decades and is associated with a modest reduction in all-cause mortality. ACCORD, ADVANCE, VADT suggested no significant reduction in CVD outcomes with intensive glycemic control. Care.DiabetesJournals.org There is evidence for a cardiovascular benefit of intensive glycemic control after long-term follow-up of study cohorts treated early in the course of both type 1 and type 2 diabetes. For example in the Diabetes Control & Complications Trial (DCCT) there was a trend toward lower risk of CVD events with intensive control. In the 9-year post-DCCT follow-up of the Epidemiology of Diabetes Interventions and Complications (EDIC) cohort, participants previously randomized to the intensive arm had a significant 57% reduction in the risk of nonfatal myocardial infarction (MI), stroke, or CVD death compared with those previously in the standard arm. The benefit of intensive glycemic control in this type 1 diabetic cohort has been shown to persist for several decades and to be associated with a modest reduction in all-cause mortality The ACCORD, ADVANCE, and VADT suggested no significant reduction in CVD outcomes with intensive glycemic control in participants followed for 3.5−5.6 years who had more advanced type 2 diabetes than UKPDS participants. Details of these studies are reviewed extensively in the Association’s position statement on intensive glycemic control and the prevention of cardiovascular events, which you can download for free from care.diabetesjournals.org. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Glycemic targets. Diabetes Care 2016; 39 (Suppl. 1): S39-S46 96

Approach to the Management of Hyperglycemia
Patient/Disease Features A1C 7% more stringent less stringent Risks associated with hypoglycemia & other drug adverse effects low high Disease Duration newly diagnosed long-standing Life expectancy long short Important comorbidities absent Few/mild severe Established vascular complications absent Few/mild severe This slide, “Approach to Management of Hyperglycemia,” depicts the elements of decision making used to determine appropriate efforts to achieve glycemic targets1 (Adapted with permission from Inzucchi et al.) You may have seen this before, but in case not we’ll walk through it briefly. Going down the left side you see a series of patient or disease characteristics with a corresponding A1C impact scale on the right. The small end of the triangle aligns with a more stringent A1C and the fatter end aligns with less stringent A1C. So taking the first one, the red triangle, risks associated with hypoglycemia and other drug adverse effects…. Clearly the risks are lower with a more stringent A1C and higher with a less stringent A1C. These are grouped into two categories, the [CLICK] top set consists of factors that are usually not modifiable and [CLICK] the bottom set may be potentially modifiable. Where possible, such decisions should be made in conjunction with the patient, reflecting his or her preferences, needs, and values This “scale” is not designed to be applied rigidly but to be used as a broad construct to help guide clinical decisions Those with long duration of diabetes, known history of severe hypoglycemia, advanced atherosclerosis, and advanced age/frailty may benefit from less aggressive targets Providers should be vigilant in preventing severe hypoglycemia in patients with advanced disease and should not aggressively attempt to achieve near-normal A1C levels in patients in whom such targets cannot be safely and reasonably achieved Severe or frequent hypoglycemia is an absolute indication for the modification of treatment regimens, including setting higher glycemic goals [SLIDE] Patient attitude & expected treatment efforts highly motivated, adherent, excellent self-care capabilities less motivated, nonadherent, poor self-care capabilities Resources & support system readily available limited American Diabetes Association Standards of Medical Care in Diabetes. Glycemic targets. Diabetes Care 2016; 39 (Suppl. 1): S39-S46 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S25; Figure 1 Ismail-Beigi F, Moghissi E, Tiktin M, Hirsch IB, Inzucchi SE, Genuth S. Individualizing glycemic targets in type 2 diabetes mellitus: implications of recent clinical trials. Ann Intern Med 2011;154:554–559 97

Glycemic Recommendations for Nonpregnant Adults with Diabetes
A1C <7.0%* (<53 mmol/mol) Preprandial capillary plasma glucose 80–130 mg/dL* (4.4–7.2 mmol/L) Peak postprandial capillary plasma glucose† <180 mg/dL* (<10.0 mmol/L) Shown here are the Association’s recommended glycemic goals for many nonpregnant adults. These recommendations are based on those for A1C values, with listed blood glucose levels that appear to correlate with achievement of an A1C of <7% [SLIDE] * Goals should be individualized. † Postprandial glucose measurements should be made 1–2 hours after the beginning of the meal. American Diabetes Association Standards of Medical Care in Diabetes. Glycemic targets. Diabetes Care 2016; 39 (Suppl. 1): S39-S46 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S25–S26; Table 9 American Diabetes Association. Postprandial blood glucose. Diabetes Care 2001;24:775–778 Ceriello A, Taboga C, Tonutti L, et al. Evidence for an independent and cumulative effect of postprandial hypertriglyceridemia and hyperglycemia on endothelial dysfunction and oxidative stress generation: effects of short- and long-term simvastatin treatment. Circulation 2002;106:1211–1218 98

Glycemic Recommendations for Nonpregnant Adults with Diabetes
More or less stringent glycemic goals may be appropriate for individual patients. Postprandial glucose may be targeted if A1C goals are not met despite reaching preprandial glucose goals. It should be noted that all glycemic goals should be individualized to each patient, and the slide on approach to hyperglycemia, which is figure 5.1 in the Association’s Standards of Care, can help with the customization. The issue of preprandial versus postprandial is complex. Elevated postprandial glucose levels have been associated with increased cardiovascular risk independent of fasting plasma glucose and it’s clear that postprandial and preprandial glucose both contribute to A1C. But outcome studies have shown that A1C is the primary predictor of complications, and landmark glycemic control trials such as the DCCT and UKPDS relied overwhelmingly on preprandial SMBG. So generally speaking it’s wise to rely on preprandial glucose measurements but do consider recommending postprandial testing for individuals who have premeal glucose values within target but have A1C values above target. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Glycemic targets. Diabetes Care 2016; 39 (Suppl. 1): S39-S46 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S26; Table 9 99

Recommendations: Hypoglycemia
Individuals at risk for hypoglycemia should be asked about symptomatic and asymptomatic hypoglycemia at each encounter. C Glucose (15–20 g) preferred treatment for conscious individual with hypoglycemia. E Prescribe glucagon for all patients at significant risk of severe hypoglycemia. Instruct caregivers in administration. E Hypoglycemia unawareness or one or more episodes of severe hypoglycemia should trigger treatment re-evaluation. E Moving on to hypoglycemia recommendations, hypoglycemia is the leading limiting factor in the glycemic management of patients with type 1 and insulin-treated type 2 diabetes. Individuals at risk for hypoglycemia should be asked about symptomatic and asymptomatic hypoglycemia at each encounter [CLICK] Glucose (15–20 g) is the preferred treatment for the conscious individual with hypoglycemia, although any form of carbohydrate that contains glucose may be used; after 15 min of treatment, if SMBG shows continued hypoglycemia, the treatment should be repeated. Once SMBG returns to normal, the individual should consume a meal or snack to prevent recurrence of hypoglycemia. [CLICK] Glucagon should be prescribed for all individuals at significant risk of severe hypoglycemia, and caregivers or family members of these individuals should be instructed in its administration; glucagon administration is not limited to health care professionals. A glucagon kit does require a prescription; some patients may want more than one kit, for example, one to keep at school or work and another for home. Care should be taken to ensure that glucagon kits are not expired; its worth reminding patients to check expiration dates upon receipt and perhaps jotting the date down on a calendar. [CLICK] Hypoglycemia unawareness or one or more episodes of severe hypoglycemia should trigger re- evaluation of the treatment regimen [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Glycemic targets. Diabetes Care 2016; 39 (Suppl. 1): S39-S46 References Cryer PE. Hypoglycaemia: the limiting factor in the glycaemic management of Type I and Type II diabetes. Diabetologia 2002;45:937–948 American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S33–S34 100

Recommendations: Hypoglycemia (2)
Insulin-treated patients with hypoglycemia unawareness or an episode of severe hypoglycemia should be advised to raise glycemic targets to strictly avoid further hypoglycemia for at least several weeks, to partially reverse hypoglycemia unawareness, and to reduce risk of future episodes. A Ongoing assessment of cognitive function is suggested with increased vigilance for hypoglycemia by the clinician, patient, and caregivers if low cognition and/or declining cognition is found. B Insulin-treated patients with hypoglycemia unawareness or an episode of severe hypoglycemia should be advised to raise their glycemic targets to strictly avoid further hypoglycemia for at least several weeks, to partially reverse hypoglycemia unawareness and reduce risk of future episodes [CLICK] And finally, do conduct ongoing assessments of cognitive function, and if low or declining cognition is found, exercise increased vigilance for hypoglycemia. A large cohort study suggested that among older adults with type 2 diabetes, a history of severe hypoglycemia was associated with greater risk of dementia2 Conversely, in a substudy of the ACCORD trial, cognitive impairment at baseline or decline in cognitive function during the trial was significantly associated with subsequent episodes of severe hypoglycemia3 Mild hypoglycemia may be inconvenient or frightening to patients with diabetes Severe hypoglycemia can cause acute harm to the person with diabetes or others, especially if it causes falls, motor vehicle accidents, or other injury [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Glycemic targets. Diabetes Care 2016; 39 (Suppl. 1): S39-S46 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S33–S34 101

Obesity Management for the Treatment of Type 2 Diabetes
This is a new section for 2016, incorporating prior recommendations related to bariatric surgery, new recommendations for the comprehensive assessment of weight in diabetes and on the treatment of overweight and obesity with behavior modification and pharmacotherapy. This section also includes a new table of currently approved medications for the long-term treatment of obesity. [SLIDE] 102

Benefits of Weight Loss
Delay progression from prediabetes to type 2 diabetes Positive impact on treatment of type 2 diabetes Most likely to occur early in disease development Improves mobility, physical and sexual functioning & health-related quality of life There is strong and consistent evidence that obesity management can delay progression from prediabetes to type 2 diabetes (1,2), and benefits type 2 diabetes treatment. [CLICK] Weight loss induced improvements in glycemia are most likely to occur early in the natural history of type 2 diabetes when obesity-associated insulin resistance has caused reversible β- cell dysfunction, but insulin secretory capacity remains relatively preserved [CLICK] Many studies document other benefits of weight loss in patients with type 2 diabetes including improvements in mobility, physical and sexual functioning, and health-related quality-of-life. And just a reminder that this entire section pertains to the treatment of type 2 diabetes specifically. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Obesity management for the treatment of type 2 diabetes. Diabetes Care 2016; 39 (Suppl. 1): S47-S51 103

Recommendations: Assessment
At each patient encounter, BMI should be calculated and documented in the medical record. B Discuss with the patient Asian American cutpoints: Normal <23 BMI kg/m2 Overweight kg/m2 Obese kg/m2 Extremely obese ≥37.5 kg/m2 As far as assessment is concerned, just one recommendation, and that is to calculate and document BMI in the medical record at each patient encounter. Be sure to also discuss it with the patient and [CLICK] remember that cutpoints for your Asian American patients are lower. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Obesity management for the treatment of type 2 diabetes. Diabetes Care 2016; 39 (Suppl. 1): S47-S51 104

Overweight/Obesity Treatment
Body Mass Index Category (kg/m2) Treatment 23.0* or ≥40 Diet, physical activity & behavioral therapy ┼ Pharmacotherapy Bariatric surgery This chart is a quick summary of recommended treatment course for patients across various BMI categories. [SLIDE] * Asian-American individuals ┼ Treatment may be indicated for selected, motivated patients. American Diabetes Association Standards of Medical Care in Diabetes. Obesity management for the treatment of type 2 diabetes. Diabetes Care 2016; 39 (Suppl. 1): S47-S51 105

Recommendations: Diet, physical activity & behavioral therapy
Diet, physical activity & behavioral therapy designed to achieve 5% weight loss should be prescribed for overweight & obese patients with T2DM ready to achieve weight loss. A Interventions should be high- intensity (≥16 sessions in 6 months) and focus on diet, physical activity & behavioral strategies to achieve a kcal/day energy deficit. A Recommendations in the area of diet, physical activity, and behavioral therapy are on the next three slides. First, for your overweight and obese patients with type 2 diabetes who are ready to achieve weight loss, prescribe diet, physical activity, and behavioral therapy designed to achieve 5% weight loss. [CLICK] These interventions should be high-intensity, which is defined as at least 16 sessions in 6 months, and should focus on diet, physical activity and behavioral strategies to achieve a daily calorie deficit of kcals. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Obesity management for the treatment of type 2 diabetes. Diabetes Care 2016; 39 (Suppl. 1): S47-S51 106

Diets that provide the same caloric restriction but differ in protein, carbohydrate, and fat content are equally effective in achieving weight loss. A Patients who achieve short-term weight loss goals should be prescribed long-term maintenance programs. A Third, diets that provide the same caloric restriction but differ in protein, carbohydrate, and fat content are equally effective in achieving weight loss. [CLICK] Overweight and obese patients with type 2 diabetes who have lost weight during the six-month intensive behavioral lifestyle intervention should be enrolled in long-term (≥1 year), comprehensive, weight loss maintenance programs that provide at least monthly contact with a trained interventionist and focus on ongoing monitoring of body weight (weekly or more frequently), continued consumption of a reduced-calorie diet, and participation in high levels of physical activity (200 to 300 minutes per week). Some commercial and proprietary weight-loss programs have shown promising weight loss results (20). [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Obesity management for the treatment of type 2 diabetes. Diabetes Care 2016; 39 (Suppl. 1): S47-S51 107

Short-term high-intensity lifestyle interventions that employ very low calorie diets and total meal replacements may be prescribed for select patients by trained practitioners with close medical monitoring. To maintain weight loss, such programs must incorporate long- term, comprehensive, weight maintenance counseling. B And finally, in carefully selected patients, short-term, high-intensity lifestyle interventions that employ very low calorie diets (defined as 800 calories/day or less) or total meal replacements can be prescribed, when provided by trained practitioners in medical care settings with close medical monitoring. These should be for a short-term (3 months) and may help achieve greater short-term weight loss (10-15%) than intensive behavioral lifestyle interventions that typically achieve 5% weight loss. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Obesity management for the treatment of type 2 diabetes. Diabetes Care 2016; 39 (Suppl. 1): S47-S51 108

Recommendations: Pharmacotherapy
Consider impact on weight when choosing glucose-lowering meds for overweight or obese patients. E Minimize the medications for comorbid conditions that are associated with weight gain. E Weight loss meds may be effective adjuncts to diet, physical activity & behavioral counseling for select patients. A Four recommendations in the area of pharmacotherapy: First, consider the potential impact on weight when choosing glucose-lowering medications for your overweight or obese patients with type 2 diabetes. The full Standards of Care document includes a handy table on medications approved by the FDA for the long-term treatment of obesity that is handy when trying to select aa treatment option. [CLICK] Minimize the medications for comorbid conditions that are associated with weight gain, [CLICK] and remember that weight loss medications may be effective adjuncts to lifestyle intervention for select type 2 patients with a BMI ≥27 kg/m2. Potential benefits must be weighed against the potential risks of the medications. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Obesity management for the treatment of type 2 diabetes. Diabetes Care 2016; 39 (Suppl. 1): S47-S51 109

Recommendations: Pharmacotherapy
If patient response to weight loss medications <5% after 3 months or there are safety or tolerability issues at any time, discontinue medication and consider alternative medications or treatment approaches. A And finally under pharmacotheraphy, if a patient’s response to medications is less than 5% weight loss after 3 months, or if there are safety or tolerability issues at any time, discontinue the medication and consider alternative medications or treatment approaches. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Obesity management for the treatment of type 2 diabetes. Diabetes Care 2016; 39 (Suppl. 1): S47-S51 110

Bariatric Surgery Guidelines support gastric banding, gastrectomy, and bypass as effective treatments for overweight T2DM patients. In 72% of patients, bariatric surgery helped achieve near- or complete normalization of glycemia 2 yrs post- surgery. In one meta-analysis, gastric banding resulted in less weight loss than gastrectomy or Roux-en-Y. Either gastric banding or procedures that involve resecting, bypassing, or transposing sections of the stomach and small intestine, can be effective weight-loss treatments for severe obesity when performed as part of a comprehensive weight-management program with lifelong lifestyle support and medical monitoring. Bariatric surgery has been shown to achieve near- or complete normalization of glycemia 2 years following surgery in 72% of patients. If you’re trying to choose between banding, gastrectomy and bypass, in one meta-analysis, gastric banding resulted in less weight loss than sleeve gastrectomy and Roux-en-Y, with one- year excess weight loss ~33% vs ~70%. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Obesity management for the treatment of type 2 diabetes. Diabetes Care 2016; 39 (Suppl. 1): S47-S51 111

Recommendations: Bariatric Surgery
Bariatric surgery may be considered for adults with BMI >35 and T2DM, especially if diabetes or associated comorbidities are difficult to control with lifestyle & medications. B Patients with T2DM who have undergone bariatric surgery need lifelong lifestyle support and annual medical monitoring, at a minimum. B National guidelines support consideration for bariatric surgery for people with type 2 diabetes with BMI >35, particularly if diabetes or associated comorbidities are difficult to control with lifestyle and pharmacological therapy. [CLICK] Second, patients with type 2 diabetes who have undergone bariatric surgery need lifelong lifestyle support and annual medical monitoring, at a minimum. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Obesity management for the treatment of type 2 diabetes. Diabetes Care 2016; 39 (Suppl. 1): S47-S51 112

Recommendations: Bariatric Surgery
Although small trials have shown glycemic benefit of bariatric surgery in patients with T2DM and BMI 30–35, there is currently insufficient evidence to generally recommend surgery in patients with BMI ≤35. E And finally, although small trials have shown glycemic benefit of bariatric surgery in patients with type 2 diabetes and BMI between 30-35, there is currently insufficient evidence to generally recommend surgery in patients with BMIs of 35 or under. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Obesity management for the treatment of type 2 diabetes. Diabetes Care 2016; 39 (Suppl. 1): S47-S51 113

Disadvantages Costly Some associated risks Outcomes vary
Patients undergoing bariatric surgery may be at higher risk for substance abuse There are several disadvantages to keep in mind when considering bariatric surgery for your patients with type 2 diabetes. First, it’s costly. And there still are associated risks, though morbidity and mortality rates have decreased considerably in recent years, with 30-day mortality rates now 0.2% for laparoscopic procedures and 2.1% for open procedures. Finally, some recent studies suggest that patients who undergo bariatric surgery may be at higher risk for substance use including drug and alcohol use and cigarette smoking. Understanding the long-term benefits and risks of bariatric surgery in patients with type 2 diabetes, especially those who are not severely obese, will require well-designed clinical trials, with optimal medical therapy as the comparator. Unfortunately, such studies may not be feasible. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Obesity management for the treatment of type 2 diabetes. Diabetes Care 2016; 39 (Suppl. 1): S47-S51 114

Approaches to Glycemic Treatment
115

Recommendations: Pharmacological Therapy For Type 1 Diabetes
Most people with T1DM should be treated with multiple dose insulin (MDI) injections (3–4 injections /day of basal & prandial insulin) or continuous subcutaneous insulin infusion (CSII). A Individuals who have been successfully using CSII should have continued access after they turn 65 years old. E Starting off with type 1 diabetes, there are plenty of other resources out there on initiating and managing insulin therapy, so we won’t go into that here. Most of your patients with type 1 diabetes should be treated with multiple dose injections or insulin pump therapy. There are minimal differences between the two as far as hypoglycemia is concerned. Whichever one a patient chooses, intensive management and active patient or family participation should be strongly encouraged. [CLICK] Individuals who have been successfully using an insulin pump should have continued access after they turn 65. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Approaches to glycemic treatment. Diabetes Care 2016; 39 (Suppl. 1): S52-S59 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S26 The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977–986 Nathan DM, Cleary PA, Backlund JY, et al for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 2005;353:2643–2653 116

Recommendations: Pharmacological Therapy For Type 1 Diabetes (2)
Consider educating individuals with T1DM on matching prandial insulin dose to carbohydrate intake, premeal blood glucose, and anticipated activity. E Most individuals with T1DM should use insulin analogs to reduce hypoglycemia risk. A Consider educating your patients with type 1 diabetes on matching prandial insulin doses to carbohydrate intake, premeal blood glucose, and anticipated activity. [CLICK] And finally, most individuals with type 1 should use insulin analogs to reduce the risk of hypoglycemia. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Approaches to glycemic treatment. Diabetes Care 2016; 39 (Suppl. 1): S52-S59 117

Pramlintide FDA approved for T1DM Amylin analog
Delays gastric emptying, blunts pancreatic glucose secretion, enhances satiety Induces weight loss, lowers insulin dose Requires reduction in prandial insulin to reduce risk of severe hypos Pramlintide is an FDA approved amylin analog that delays gastric emptying, blunts pancreatic glucose secretion, and enhances satiety. It can induce weight loss and lower the insulin dose, but does require the concurrent reduction of prandial insulin to lower the risk of severe hypoglycemia. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Approaches to glycemic treatment. Diabetes Care 2016; 39 (Suppl. 1): S52-S59 118

Pancreas and Islet Cell Transplantation
Can normalize glucose but require lifelong immunosuppression. Reserve for T1D patients: Undergoing renal transplant Following renal transplant With recurrent ketoacidosis or severe hypos Islet cell transplant investigational Consider for patients requiring pancreatectomy who meet eligibility criteria. A few words on transplantation. Pancreatic or islet cell transplantation can normalize glucose levels but require lifelong immunosuppression to prevent graft rejection and recurrence of islet destruction. Therefore, pancreas transplantation should be reserved for type 1 patients undergoing simultaneous renal transplantation, following renal transplantation, or for those with recurrent ketoacidosis or severe hypoglycemia despite aggressive glycemic management. Islet cell transplantation remains investigational. Auto-islet transplantation may be considered for patients requiring total pancreatectomy who meet eligibility criteria. {SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Approaches to glycemic treatment. Diabetes Care 2016; 39 (Suppl. 1): S52-S59 119

Recommendations: Pharmacological Therapy For T2DM
Metformin, if not contraindicated and if tolerated, is the preferred initial pharmacological agent for T2DM. A In patients with newly dx’d T2DM and markedly symptomatic and/or elevated blood glucose levels or A1C, consider insulin therapy (with or without additional agents). E Recommended pharmacological therapy for hyperglycemia in type 2 diabetes1 is summarized on the next two slides. First, metformin, if not contraindicated and if tolerated, is the preferred initial pharmacological agent for type 2 diabetes. Metformin has a long-standing evidence base for efficacy and safety, is inexpensive, and may reduce risk of cardiovascular events. [CLICK] In patients with newly diagnosed patients type 2 diabetes and markedly symptomatic or elevated blood glucose levels or A1C, consider insulin therapy, with or without additional agents, from the outset [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Approaches to glycemic treatment. Diabetes Care 2016; 39 (Suppl. 1): S52-S59 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S27 Inzucchi SE, Bergenstal RM, Buse JB, et al.; American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycemia in type 2 diabetes: a patient-centered approach. Position Statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012;35:1364–1379 120

Recommendations: Pharmacological Therapy For T2DM (2)
If noninsulin monotherapy at maximal tolerated dose does not achieve or maintain the A1C target over 3 months, add a second oral agent, a GLP-1 receptor agonist, or insulin. A Use a patient-centered approach to treatment. E Don’t delay insulin initiation in patients not achieving glycemic goals. B If noninsulin monotherapy at maximal tolerated dose does not achieve or maintain the A1C target over 3 months, add a second oral agent, a glucagon-like peptide 1 (GLP-1) receptor agonist, or insulin [CLICK] A patient centered approach should be used to guide the choice of pharmacological agents. Considerations include efficacy, cost, potential side effects, weight, comorbidities, hypoglycemia risk, and patient preference. [CLICK] And finally, for patients with type 2 diabetes who are not achieving glycemic goals, insulin therapy should not be delayed. The Association has a comprehensive algorithm for antihyperglycemic therapy which appears as figure 7.1 in the full recommendations. I won’t go through it here but do download it in the full recommendations. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Approaches to glycemic treatment. Diabetes Care 2016; 39 (Suppl. 1): S52-S59 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S27 Holman RR, Paul SK, Bethel MA,Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008;359:1577–1589 Bennett WL, Maruthur NM, Singh S, et al. Comparative effectiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug combinations. Ann Intern Med 2011;154:602–613 121

Insulin Therapy in T2DM The progressive nature of T2DM should be regularly & objectively explained to T2DM patients. For T2DM patients not achieving glycemic goals, promptly initiate insulin therapy. Avoid using insulin as a threat, describing it as a failure or punishment. Give patients a self-titration algorithm. The progressive nature of T2DM should be regularly & objectively explained to T2DM patients. Along those lines, for your patients who are not achieving glycemic goals, promptly initiate insulin therapy Avoid using insulin as a threat, describing it as a failure or punishment And do give patients a self-titration algorithm [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Approaches to glycemic treatment. Diabetes Care 2016; 39 (Suppl. 1): S52-S59 122

Inhaled Insulin Now available Prandial use Limited dosing range
May require serial lung function testing before and after starting therapy Just a few quick words on inhaled insulin, which is now FDA approved and available. It’s available for prandial use with a more limited dosing range, and may require serial lung function testing prior to and after starting therapy. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Approaches to glycemic treatment. Diabetes Care 2016; 39 (Suppl. 1): S52-S59 123

Cardiovascular Disease and Risk Management
Moving on to cardiovascular disease and risk management…. [SLIDE] 124

Cardiovascular Disease
CVD is the leading cause of morbidity & mortality for those with diabetes. Largest contributor to direct/indirect costs Common conditions coexisting with type 2 diabetes (e.g., hypertension, dyslipidemia) are clear risk factors for ASCVD. Diabetes itself confers independent risk Control individual cardiovascular risk factors to prevent/slow CVD in people with diabetes. Systematically assess all patients with diabetes for cardiovascular risk factors. Cardiovascular disease is the major cause of morbidity and mortality for individuals with diabetes, and the largest contributor to the direct and indirect costs of diabetes [CLICK] The common conditions coexisting with type 2 diabetes, such as hypertension and dyslipidemia, are clear risk factors for atherosclerotic cardiovascular disease, and diabetes itself confers independent risk [CLICK] Common conditions coexisting with type 2 diabetes are clear risk factors for ASCVD. [CLICK] Diabetes confers independent risk for ASCVD [CLICK] Numerous studies have shown the efficacy of controlling individual cardiovascular risk factors in preventing of slowing CVD in people with diabetes. Large benefits are seen when multiple risk factors are addressed globally. [CLICK] Finally, the Association recommends systematic assessment at least annually of all people with diabetes for cardiovascular risk factors, including dyslipidemia, hypertension, smoking, family history of premature coronary disease, and the presence of albuminuria. Abnormal risk factors should be treated. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S36 Buse JB, Ginsberg HN, Bakris GL, et al., for the American Heart Association, American Diabetes Association. Primary prevention of cardiovascular diseases in people with diabetes mellitus: a scientific statement from the American Heart Association and the American Diabetes Association. Diabetes Care 2007;30:162–172 Gaede P, Lund-Andersen H, Parving HH, Pedersen O. Effect of a multifactorial intervention on mortality in type 2 diabetes. N Engl J Med 2008;358:580–591 Ali MK, Bullard KM, Saaddine JB, Cowie CC, Imperatore G, Gregg EW. Achievement of goals in U.S. diabetes care, 1999–2010. N Engl J Med 2013;368:1613–1624 125

Hypertension Common DM comorbidity
Prevalence depends on diabetes type, age, BMI, ethnicity Major risk factor for ASCVD & microvascular complications In T1DM, HTN often results from underlying kidney disease. In T2DM, HTN coexists with other cardiometabolic risk factors. Hypertension is a common diabetes comorbidity that affects many patients, with the prevalence depending on type of diabetes, age, BMI, and ethnicity. Hypertension is a major risk factor for both ASCVD and microvascular complications. In type 1 diabetes, hypertension is often the result of underlying diabetic kidney disease, while in type 2 diabetes, it usually coexists with other cardiometabolic risk factors. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 126

Blood Pressure Control & T2DM
Action to Control Cardiovascular Risk in Diabetes (ACCORD): Does SBP <120 provide better cardiovascular protection than SBP ? No. ADVANCE-BP: Significant risk reduction Given the epidemiological relationship between lower blood pressure and better long-term clinical outcomes, two landmark trials, Action to Control Cardiovascular Risk in Diabetes, or ACCORD trial, and Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation–Blood Pressure (ADVANCE-BP), examined the benefit of tighter blood pressure control in patients with type 2 diabetes. [CLICK] The ACCORD trial examined whether a lower SBP of <120 mm Hg, in type 2 diabetes patients at high risk for ASCVD, provided greater cardiovascular protection than an SBP level of 130– 140 mm Hg and the study did not find a benefit in primary endpoints of nonfatal MI, nonfatal stroke and cardiovascular death. The ADVANCE-BP intervention arm consisted of a single pill, fixed dose ation of perindopril and indapamide and [CLICK] showed a significant reduction in the risk of the primary composite end point (major macrovascular or microvascular event) and significant reductions in the risk of death from any cause and of death from cardiovascular causes. Recently published 6-year follow-up of the ADVANCE-ON study reported that the reductions in the risk of death from any cause and of death from cardiovascular causes in the intervention group were attenuated, but remained significant [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 127

Recommendations: Hypertension/ Blood Pressure Control
Screening and Diagnosis: Blood pressure should be measured at every routine visit. B Patients found to have elevated blood pressure should have blood pressure confirmed on a separate day. B Moving along to recommendations, blood pressure should be measured at every routine visit, and patients found to have elevated blood pressure should have blood pressure confirmed on a separate day. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S36 128

Recommendations: Hypertension/ Blood Pressure Control (2)
Systolic Targets: People with diabetes and hypertension should be treated to a systolic blood pressure goal of <140 mmHg. A Lower systolic targets, such as <130 mmHg, may be appropriate for certain individuals, such as younger patients, if it can be achieved without undue treatment burden. C People with diabetes and hypertension should be treated to a systolic blood pressure goal of <140 mmHg. There is strong evidence that systolic BP greater than 140 is harmful, and suggests clinicians should promptly initiate and titrate therapy in an ongoing fashion to achieve and maintain SBP <140 mmHg in most patients; We’ll talk about your older adult patients shortly; Lower systolic targets, such as <130 mmHg, may be appropriate for certain individuals, such as younger patients, if it can be achieved without undue treatment burden. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S36 129

Diastolic Targets: Patients with diabetes should be treated to a diastolic blood pressure <90 mmHg. A Lower diastolic targets, such as <80 mmHg, may be appropriate for certain individuals, such as younger patients, if it can be achieved without undue treatment burden. B Similarly, strong evidence from randomized clinical trials supports diastolic blood pressure targets less than 90. Lower diastolic targets, such as <80 mmHg, may be appropriate for certain individuals, such as younger patients, if it can be achieved without undue treatment burden. These targets are in harmonization with a recent publication by the Eighth Joint National Committee that recommended, for individuals over 18 years of age with diabetes, a DBP threshold of <90 mmHg and SBP <140 mmHg. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S36 130

Treatment: Patients with BP >120/80 should be advised on lifestyle changes to reduce BP. B Patients with confirmed BP >140/90 should, in addition to lifestyle therapy, have prompt initiation and timely subsequent titration of pharmacological therapy to achieve blood pressure goals. A Recommendations in the are of treatment of high blood pressure: Patients with blood pressure >120/80 should be advised on lifestyle changes to reduce blood pressure Patients with confirmed blood pressure higher than 140/90 should, in addition to lifestyle therapy, have prompt initiation and timely subsequent titration of pharmacological therapy to achieve blood pressure goals [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S36 131

Treatment (2): In older adults, pharmacological therapy to achieve treatment goals of <130/70 are not recommended. B Lifestyle intervention including B: Weight loss if overweight DASH-style diet including reduced sodium, increased potassium Moderation of alcohol intake Increased physical activity In older adults pharmacological therapy to reach goals of less than 130/70 is not recommended. Treating to less than SBP less than 130 has not been shown to improve cardiovascular outcomes and treating to DBP less than 70 has been associated with higher mortality in this population. [CLICK] Lifestyle therapy for elevated blood pressure consists of weight loss if overweight, DASH-style dietary pattern including reducing sodium and increasing potassium intake, moderation of alcohol intake, and increased physical activity [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S36 132

Treatment (3): Pharmacological therapy for patients with diabetes and HTN includes: either an ACE inhibitor or angiotensin II receptor blocker B if one class is not tolerated, substitute the other C Multiple drug therapy (two or more agents at maximal doses) generally required to achieve BP targets. B Pharmacologic therapy for patients with diabetes and hypertension should be paired with a regimen that included either an ACE inhibitor or an angiotensin II receptor blocker (ARB), but not both. If one class is not tolerated, the other should be substituted Multiple drug therapy (two or more agents at maximal doses) is generally required to achieve blood pressure targets [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S36 133

Treatment (4): If using ACE inhibitors, ARBs, or diuretics, monitor serum creatinine / eGFR & potassium levels. E In pregnant patients with DM and chronic hypertension, BP targets of 110–129/65–79 are suggested; ACE inhibitors, ARBs, contraindicated during pregnancy. E If ACE inhibitors, ARBs, or diuretics are used, be sure to monitor serum creatine/ eGFR and serum potassium levels And finally In pregnant patients with diabetes and chronic hypertension, blood pressure target goals of over are suggested in the interest of long-term maternal health and minimizing impaired fetal growth and ACE inhibitors and ARBs are contraindicated [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S36 134

Recommendations: Lipid Management
In adults not taking statins, a screening lipid profile is reasonable (E): At diabetes diagnosis At the initial medical evaluation And every 5 years, or more frequently if indicated Obtain a lipid profile at initiation of statin therapy, and periodically thereafter. E Moving on to recommendations for lipid management. In adults not taking statins, there are several points when it’s reasonable to obtain a lipid profile: a screening lipid profile is reasonable at the time of first diabetes diagnosis, at the initial medical evaluation, and every five years, or more often if indicated. You should also get a lipid profile at the initiation of statin therapy, and periodically thereafter as it may help monitor the response to therapy and inform adherence. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S38 135

Recommendations: Lipid Management (2)
To improve lipid profile in patients with diabetes, recommend lifestyle modification A, focusing on: Weight loss (if indicated) Reduction of saturated fat, trans fat, cholesterol intake Increase of n-3 fatty acids, viscous fiber, plant stanols/sterols Increased physical activity Next, recommendations for lipid management. Lifestyle modification focusing on the reduction of saturated fat, trans fat, and cholesterol intake; increase of n-3 fatty acids, viscous fiber, and plant stanols/sterols; weight loss (if indicated) and increased physical activity should be recommended to improve the lipid profile in patients with diabetes. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S38 136

Intensify lifestyle therapy & optimize glycemic control for patients with: C Triglyceride levels >150 mg/dL (1.7 mmol/L) and/or HDL cholesterol <40 mg/dL (1.0 mmol/L) in men and <50 mg/dL (1.3 mmol/L) in women For patients with fasting triglyceride levels ≥ 500 mg/dL (5.7 mmol/L), evaluate for secondary causes and consider medical therapy to reduce the risk of pancreatitis. C For your patients with triglyceride levels over 150 or low HDL, intensify lifestyle therapy and work to optimize glycemic control. If trigs are 500 or higher, do evaluate for secondary causes and consider medical therapy to reduce the risk of pancreatitis. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S38 137

Recommendations for Statin Treatment in People with Diabetes
Age Risk Factors Statin Intensity* <40 years None ASCVD risk factor(s)** Moderate or high ASCVD High 40–75 years Moderate ASCVD risk factors ACS & LDL >50 who can’t tolerate high dose statin Moderate + ezetimibe >75 years Here is a summary of recommendations for statin treatment in people with diabetes. All of these recommendations are in addition to lifestyle therapy, as indicated by the asterisk by Recommended Statin Intensity. For your patients less than 40 years old without ASCVD risk factors, no statins are recommended. If they do have risk factors-- which, as indicated by the double asterisk there, include LDL ≥100 mg/dL (2.6 mmol/L), high blood pressure, smoking, overweight or obesity, and family history of premature ASCVD–moderate or high dose statin therapy is recommended. For patients with overt ASCVD, a high dose is recommended. For your patients aged with no risk factors, moderate dose statin therapy is recommended in addition to lifestyle. For patients in this age group with ASCVD risk factors, a high dose is recommended, and for your patients with acute coronary syndrome and LDL over 50 who can’t tolerate high dose statin therapy, a moderate dose plus ezetimibe is recommended (along with lifestyle intervention). And finally, for your patients over 75 years old with no risk factors, a moderate dose is recommended. With ASCVD risk factors, a moderate or high dose, and with overt ASCVD, a high dose along with that lifestyle therapy. And again for your patients in this age group with acute coronary syndrome and LDL over 50 who can’t tolerate high dose statin therapy, moderate dose plus ezetimibe is recommended. [SLIDE] *In addition to lifestyle therapy. **ASCVD risk factors include LDL cholesterol ≥100 mg/dL (2.6 mmol/L), high blood pressure, smoking, overweight and obesity, and family history of premature ASCVD. * In addition to lifestyle therapy. ** ASCVD risk factors include LDL cholesterol ≥100 mg/dL (2.6 mmol/L), high blood pressure, smoking, overweight and obesity, and family history of premature ASCVD. American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S38 138

In clinical practice, providers may need to adjust intensity of statin therapy based on individual patient response to medication (e.g., side effects, tolerability, LDL cholesterol levels). E Ezetimibe + moderate intensity statin therapy provides add’l CV benefit over moderate intensity statin therapy alone; consider for patients with a recent acute coronary syndrome w/ LDL ≥ 50mg/dL or in patients who can’t tolerate high-intensity statin therapy. A In clinical practice, providers may need to adjust intensity of statin therapy based on individual patient response to medication (e.g., side effects, tolerability, LDL cholesterol levels). The addition of ezetimibe to moderate intensity statin therapy has been shown to provide additional cardiovascular benefit compared to moderate intensity statin therapy alone, and may be considered for patients with a recent acute coronary syndrome with an LDL cholesterol ≥ 50mg/dL or in those patients who cannot tolerate high-intensity statin therapy. {SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 139

Combination therapy (statin/fibrate) doesn’t improve ASCVD outcomes and is generally not recommended A. Consider therapy with statin and fenofibrate for men with both trigs ≥204 mg/dL (2.3 mmol/L) and HDL ≤34 mg/dL (0.9 mmol/L). B Combination therapy (statin/niacin) hasn’t demonstrated additional CV benefit over statins alone, may raise risk of stroke & is not generally recommended. A Statin therapy is contraindicated in pregnancy. B And finally, last screen: Combination therapy (statin/fibrate) has not shown to improve ASCVD outcomes and is generally not recommended. However, therapy with statin and fenofibrate may be considered for men with both triglyceride level ≥204 mg/dL and HDL cholesterol level ≤34 mg/dL Combination therapy (statin/niacin) has not been shown to provide additional cardiovascular benefit above statin therapy alone and may increase the risk of stroke and is not generally recommended. Statin therapy is contraindicated in pregnancy. {SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 140

High- and Moderate-Intensity Statin Therapy*
High Intensity Statin Therapy Lowers LDL by ≥50% Atorvastatin mg Rosuvastatin mg Moderate-Intensity Statin Therapy Lowers LDL by 30 - <50% Atorvastatin mg Rosuvastatin 5-10 mg Simvastatin mg Pravastatin mg Lovastatin 40 mg Fluvastatin XL 80 mg Pitavastatin 2-4 mg Here’s a quick summary of recommended statin dosing for high and moderate intensity therapy. Note that these are all based on once-daily dosing. [SLIDE] * Once-daily dosing American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 141

Recommendations: Antiplatelet Agents
Consider aspirin therapy (75–162 mg/day) C As a primary prevention strategy in those with type 1 or type 2 diabetes at increased cardiovascular risk (10-year risk >10%) Includes most men or women with diabetes age ≥50 years who have at least one additional major risk factor, including: Family history of premature ASCVD Hypertension Smoking Dyslipidemia Albuminuria Aspirin has been shown to be effective in reducing cardiovascular morbidity and mortality in high-risk patients with previous MI or stroke (secondary prevention). Its net benefit in primary prevention among patients with no previous cardiovascular events is more controversial, both for patients with and without diabetes. Multiple recent well-conducted studies and meta-analyses reported a risk of heart disease and stroke that is equivalent if not higher in women compared to men with diabetes, including among non-elderly adults. Thus, the recommendations for using aspirin as primary prevention are now revised to include both men and women aged 50 years or older with diabetes and one or more major risk factors, to reflect these more recent findings. Recommendations for the use of antiplatelet agents are summarized in three slides. Consider aspirin therapy as a primary prevention strategy in those with type 1 and type 2 diabetes who are at increased cardiovascular risk. This includes most men or women with diabetes aged 50 years and up who have at least one additional major risk factor (such as family history of premature ASCVD, hypertension, smoking, dyslipidemia, or albuminuria) and are not at increased risk of bleeding. [SLIDE} American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S40–S41 Pignone M, Alberts MJ, Colwell JA, et al.; American Diabetes Association; American Heart Association; American College of Cardiology Foundation. Aspirin for primary prevention of cardiovascular events in people with diabetes: a position statement of the American Diabetes Association, a scientific statement of the American Heart Association, and an expert consensus document of the American College of Cardiology Foundation. Diabetes Care 2010;33:1395–1402 142

Recommendations: Antiplatelet Agents (2)
Aspirin is not recommended for ASCVD prevention for adults with DM at low ASCVD risk, since potential adverse effects from bleeding likely offset potential benefits. C Low risk: 10-year CVD risk <5%, such as in men or women with diabetes aged <50 years with no major additional ASCVD risk factors) In patients with diabetes <50 years of age with multiple other risk factors (e.g., 10- year risk 5–10%), clinical judgment is required. E Aspirin is not recommended for those at low risk of ASCVD (such as men and women with diabetes under age 50 years with no other major ASCVD risk factors; 10-year ASCVD risk under 5%) as the low benefit is likely to be outweighed by the risks of significant bleeding. Clinical judgment should be used for those at intermediate risk such as younger patients with one or more risk factors or older patients with no risk factors until further research is available. Aspirin use in patients under the age of 21 years is contraindicated due to the associated risk of Reye syndrome. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S40–S41 143

Recommendations: Antiplatelet Agents (3)
Use aspirin therapy (75–162 mg/day) as secondary prevention in those with diabetes and history of ASCVD. A For patients w/ ASCVD & aspirin allergy, clopidogrel (75 mg/day) should be used. B Dual antiplatelet therapy is reasonable for up to a year after an acute coronary syndrome. B Average daily dosages used in most clinical trials involving patients with diabetes ranged from 50 to 650 mg but were mostly in the range of 100 to 325 mg/day. There is little evidence to support any specific dose, but using the lowest possible dose may help reduce side effects Use aspirin therapy (75–162 mg/day) as a secondary prevention strategy in those with diabetes and a history of ASCVD. For patients with ASCVD and documented aspirin allergy, clopidogrel (75 mg/day) should be used. Dual antiplatelet therapy is reasonable for up to a year after an acute coronary syndrome. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S40–S41 Vandvik PO, Lincoff AM, Gore JM, et al. Primary and secondary prevention of cardiovascular disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012;141:e637S–e668S 144

Recommendations: Coronary Heart Disease
Screening In asymptomatic patients, routine screening for CAD isn’t recommended & doesn’t improve outcomes provided ASCVD risk factors are treated. A Consider investigations for CAD with: Atypical cardiac symptoms (e.g. unexplained dyspnea, chest discomfort) Signs or symptoms of associated vascular disease incl. carotid bruits, transient ischemic attack, stroke, claudication or PAD EKG abnormalities (e.g. Q waves) E Recommendations for screening for coronary heart disease are summarized on this slide: The screening of asymptomatic patients with high ASCVD risk is not recommended, in part because these high-risk patients should already be receiving intensive medical therapy, an approach that provides similar benefit as invasive revascularization. There is also some evidence that silent MI may reverse over time, adding to the controversy concerning aggressive screening strategies But do consider investigations for coronary artery disease in the presence of any of the following: Atypical cardiac symptoms (e.g. unexplained dyspnea, chest discomfort) Signs or symptoms of associated vascular disease including carotid bruits, transient ischemic attack, stroke, claudication or peripheral arterial disease EKG abnormalities (e.g. Q waves) [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S42 145

Recommendations: Coronary Heart Disease (2)
Treatment In patients with known ASCVD, use aspirin and statin therapy (if not contraindicated) A and consider ACE inhibitor therapy C to reduce risk of cardiovascular events. In patients with a prior MI, β-blockers should be continued for at least 2 years after the event. B Treatment recommendations are summarized on two slides. As a baseline for all your patients, intensive lifestyle intervention focusing on weight loss through decreased caloric intake and increased physical activity such as in the Look AHEAD trial may be considered for improving glucose control, fitness, and some ASCVD risk factors. Patients at increased ASCVD risk should receive aspirin and a statin, and ACE inhibitor or ARB therapy if the patient has hypertension, unless there are contraindications to a particular drug class. While clear benefit exists for ACE inhibitor and ARB therapy in patients with nephropathy or hypertension, the benefits in patients with ASCVD in the absence of these conditions are less clear, especially when LDL cholesterol is concomitantly controlled. [CLICK] In patients with a prior MI, β-blockers should be continued for at least 2 years after the event. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S42 Braunwald E, Domanski MJ, Fowler SE, et al for the PEACE Trial Investigators. Angiotensin-converting-enzyme inhibition in stable coronary artery disease. N Engl J Med 2004;351:2058–2068 Yusuf S, Teo K, Anderson C, et al for the Telmisartan Randomised AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease (TRANSCEND) Investigators. Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomised controlled trial. Lancet 2008;372:1174–1183 146

Recommendations: Coronary Heart Disease (3)
Treatment In patients with symptomatic heart failure, TZDs should not be used. A In type 2 diabetes, patients with stable CHF, metformin may be used if renal function is normal but should be avoided in unstable or hospitalized patients with CHF. B In patients with symptomatic heart failure, thiazolidinedione treatment should not be used. In type 2 diabetes, patients with stable CHF, metformin may be used if renal function is normal but should be avoided in unstable or hospitalized patients with CHF. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular disease and risk management. Diabetes Care 2016; 39 (Suppl. 1): S60-S71 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S42 Braunwald E, Domanski MJ, Fowler SE, et al for the PEACE Trial Investigators. Angiotensin-converting-enzyme inhibition in stable coronary artery disease. N Engl J Med 2004;351:2058–2068 Yusuf S, Teo K, Anderson C, et al for the Telmisartan Randomised AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease (TRANSCEND) Investigators. Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomised controlled trial. Lancet 2008;372:1174–1183 147

Microvascular Complications and Foot Care
Moving onto section 9, Microvascular Complications and Foot Care. 148

Recommendations: Diabetic Kidney Disease
Screening At least once a year, assess urine albumin excretion and estimated glomerular filtration rate (eGFR): In patients with type 1 diabetes duration of ≥5 years B In all patients with type 2 diabetes B In all patients with comorbid hypertension B Recommendations for screening patients with diabetic kidney disease are highlighted on this slide. Diabetic kidney disease, or kidney disease attributed to diabetes, occurs in 20–40% of patients with diabetes and is the leading cause of end-stage renal disease (ESRD). Kidney disease not attributable to diabetes, and due to other etiologies, is referred to as chronic kidney disease (CKD). • At least once a year, assess urinary albumin (e.g., spot urine albumin-to-creatinine ratio [UACR]) and estimated glomerular filtration rate (eGFR) in patients with type 1 diabetes with duration of ≥5 years, in all patients with type 2 diabetes, and in all patients with comorbid hypertension. American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S42 149

Stages of Chronic Kidney Disease
Description GFR (mL/min/1.73 m2) 1 Kidney damage* with normal or increased GFR ≥ 90 2 Kidney damage* with mildly decreased GFR 60–89 3 Moderately decreased GFR 30–59 4 Severely decreased GFR 15–29 5 Kidney failure <15 or dialysis The National Kidney Foundation classification of the stages of chronic kidney disease is primarily based on GFR levels and may be superseded by other systems in which staging includes other variables such as urinary albumin excretion Studies have found decreased GFR in the absence of increased urine albumin excretion in a substantial percentage of adults with diabetes Substantial evidence shows that in patients with type 1 diabetes and persistent albumin levels 30–299 mg/24 h, screening with albumin excretion rate alone would miss >20% of progressive disease Serum creatinine with estimated GFR should therefore be assessed at least annually in all adults with diabetes, regardless of the degree of urine albumin excretion Serum creatinine should be used to estimate GFR and to stage the level of CKD, if present GFR calculators are available at GFR = glomerular filtration rate * Kidney damage defined as abnormalities on pathologic, urine, blood, or imaging tests. American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S44; Table 12 Levey AS, Coresh J, Balk E, et al for the National Kidney Foundation. National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med 2003;139:137–147 Kramer H, Molitch ME. Screening for kidney disease in adults with diabetes. Diabetes Care 2005;28: Kramer HJ, Nguyen QD, Curhan G, Hsu CY. Renal insufficiency in the absence of albuminuria and retinopathy among adults with type 2 diabetes mellitus. JAMA 2003;289:3273–3277 National Kidney Foundation. KDOQI clinical practice guideline for diabetes and CKD: 2012 update. Am J Kidney Dis 2012;60:850–886 150

Treatment Optimize glucose control to reduce risk or slow progression of diabetic kidney disease. A Optimize blood pressure control (<140/90 mmHg) to reduce risk or slow progression of diabetic kidney disease. A Treatment Optimize glucose control to reduce the risk or slow the progression of diabetic kidney disease. Optimize blood pressure control to reduce the risk or slow the progression of diabetic kidney disease. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S42–S43 The Diabetes Control and Complications (DCCT) Research Group. Effect of intensive therapy on the development and progression of diabetic nephropathy in the Diabetes Control and Complications Trial. Kidney Int 1995;47:1703–1720 UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998;352:854–865 UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998;317:703–713 151

Treatment (2) For people with non-dialysis dependent diabetic kidney disease, dietary protein intake should be 0.8 g/kg body weight per day. For patients on dialysis, higher levels of dietary protein intake should be considered. A Treatment For people with non-dialysis dependent diabetic kidney disease, dietary protein intake should be 0.8 g/kg body weight per day (which is the recommended daily allowance). For patients on dialysis, higher levels of dietary protein intake should be considered. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S42–S43 The Diabetes Control and Complications (DCCT) Research Group. Effect of intensive therapy on the development and progression of diabetic nephropathy in the Diabetes Control and Complications Trial. Kidney Int 1995;47:1703–1720 UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998;352:854–865 UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998;317:703–713 152

Treatment (3) Either an ACE inhibitor or ARB is recommended for treatment of nonpregnant patients with diabetes & modestly elevated urinary albumin excretion (30–299 mg/day) B and is strongly recommended for patients w/ urinary albumin excretion ≥300 mg/day and/or eGFR <60. A Either an ACE inhibitor or ARB is recommended for the treatment of nonpregnant patients with diabetes and modestly elevated urinary albumin excretion (30–299 mg/day) and is strongly recommended for those with urinary albumin excretion ≥300 mg/day and/or eGFR <60. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S42–S43 The Diabetes Control and Complications (DCCT) Research Group. Effect of intensive therapy on the development and progression of diabetic nephropathy in the Diabetes Control and Complications Trial. Kidney Int 1995;47:1703–1720 UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998;352:854–865 UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998;317:703–713 153

Treatment (4) When ACE inhibitors, ARBs, or diuretics are used, consider monitoring serum creatinine & potassium levels for increased creatinine or changes in potassium. E Continued monitoring of UACR in patients with albuminuria on an ACE inhibitor or ARB is reasonable to assess treatment response & progression of diabetic kidney disease. E Consider monitoring serum creatinine and potassium levels for the development of increased creatinine or changes in potassium, when ACE inhibitors, ARBs, or diuretics are used. Continued monitoring of UACR in patients with albuminuria treated with an ACE inhibitor or ARB is reasonable to assess response to treatment and progression of diabetic kidney disease. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S42–S43 The Diabetes Control and Complications (DCCT) Research Group. Effect of intensive therapy on the development and progression of diabetic nephropathy in the Diabetes Control and Complications Trial. Kidney Int 1995;47:1703–1720 UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998;352:854–865 UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998;317:703–713 154

Treatment (5) An ACE inhibitor or ARB isn’t recommended for primary prevention of diabetic kidney disease in patients with diabetes with normal BP, normal UACR (<30 mg/g) & normal eGFR. B When eGFR is <60, evaluate and manage potential complications of CKD. E An ACE inhibitor or ARB is not recommended for the primary prevention of diabetic kidney disease in patients with diabetes who have normal blood pressure, normal UACR (<30 mg/g), and normal eGFR. When eGFR is <60, evaluate and manage potential complications of chronic kidney disease. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S42–S43 The Diabetes Control and Complications (DCCT) Research Group. Effect of intensive therapy on the development and progression of diabetic nephropathy in the Diabetes Control and Complications Trial. Kidney Int 1995;47:1703–1720 UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998;352:854–865 UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998;317:703–713 155

Treatment (6) If patients have eGFR <30, refer for evaluation for renal replacement treatment. A Promptly refer to a physician experienced in the care of DKD for: B Uncertainty about the etiology of disease Difficult management issues Rapidly progressing kidney disease. Patients should be referred for evaluation for renal replacement treatment if they have eGFR < 30 mL/min/1.73 m2 And finally, promptly refer to a physician experienced in the care of kidney disease when there is uncertainty about the etiology of kidney disease, difficult management issues (such as anemia, secondary hyperparathyroidism, metabolic bone disease, or electrolyte disturbance), and rapidly progressing kidney disease. The threshold for referral may vary depending on the frequency with which a provider encounters diabetic patients with significant kidney disease Providers should also educate their patients about the progressive nature of DKD, the kidney preservation benefits of proactive treatment of blood pressure and blood glucose, and the potential need for renal replacement therapy. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S42–S43 The Diabetes Control and Complications (DCCT) Research Group. Effect of intensive therapy on the development and progression of diabetic nephropathy in the Diabetes Control and Complications Trial. Kidney Int 1995;47:1703–1720 UK Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34). Lancet 1998;352:854–865 UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998;317:703–713 156

Management of CKD in Diabetes
GFR Recommended All patients Yearly measurement of creatinine, urinary albumin excretion, potassium 45-60 Referral to a nephrologist if possibility for nondiabetic kidney disease exists Consider dose adjustment of medications Monitor eGFR every 6 months Monitor electrolytes, bicarbonate, hemoglobin, calcium, phosphorus, parathyroid hormone at least yearly Assure vitamin D sufficiency Consider bone density testing Referral for dietary counselling Complications of kidney disease correlate with level of kidney function When the eGFR is <60, screening for complications of CKD is indicated, as summarized on this slide Early vaccination against HBV is indicated in patients likely to progress to end-stage renal disease [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S45; Table 13 Adapted from 157

Management of CKD in Diabetes (2)
GFR Recommended 30-44 Monitor eGFR every 3 months Monitor electrolytes, bicarbonate, calcium, phosphorus, parathyroid hormone, hemoglobin, albumin weight every 3–6 months Consider need for dose adjustment of medications <30 Referral to a nephrologist Consultation with a nephrologist when stage 4 CKD develops has been found to reduce cost, improve quality of care, and keep people off dialysis longer However, nonrenal specialists should not delay educating their patients about the progressive nature of diabetic kidney disease; the renal preservation benefits of aggressive treatment of blood pressure, blood glucose, and hyperlipidemia, and the potential need for renal transplant [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S45; Table 13 Adapted from Levinsky NG. Specialist evaluation in chronic kidney disease: too little, too late. Ann Intern Med 2002;137:542–543 158

Recommendations: Diabetic Retinopathy
To reduce the risk or slow the progression of retinopathy Optimize glycemic control A Optimize blood pressure control A Diabetic retinopathy is a highly specific vascular complication of both type 1 and type 2 diabetes, with prevalence strongly related to duration of diabetes. It’s the most frequent cause of new cases of blindness among adults aged 20–74 years Glaucoma, cataracts, and other disorders of the eye occur earlier and more frequently in people with diabetes In addition to duration of diabetes, other factors that increase the risk of, or are associated with, retinopathy include chronic hyperglycemia2, the presence of nephropathy3, and hypertension4 The first line of defense against diabetic retinopathy, to reduce the risk or slow its progression, is to optimize glycemic control and blood pressure. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S44–S45 Klein R. Hyperglycemia and microvascular and macrovascular disease in diabetes. Diabetes Care 1995;18:258–268 Estacio RO, McFarling E, Biggerstaff S, Jeffers BW, Johnson D, Schrier RW. Overt albuminuria predicts diabetic retinopathy in Hispanics with NIDDM. Am J Kidney Dis 1998;31:947–953 Leske MC, Wu SY, Hennis A, et al., for the Barbados Eye Study Group. Hyperglycemia, blood pressure, and the 9-year incidence of diabetic retinopathy: the Barbados Eye Studies. Ophthalmology 2005;112:799–805 159

Recommendations: Diabetic Retinopathy (2)
Screening: Initial dilated and comprehensive eye examination by an ophthalmologist or optometrist: Adults with type 1 diabetes, within 5 years of diabetes onset. B Patients with type 2 diabetes at the time of diabetes diagnosis. B As far as screening for diabetic retinopathy, your patients with diabetes should have a dilated and comprehensive eye exam by an ophthalmologist or optometrist. Because retinopathy is estimated to take at least 5 years to develop after the onset of hyperglycemia, patients with type 1 diabetes should have an initial dilated and comprehensive eye examination within 5 years after the diagnosis of diabetes Patients with type 2 diabetes who may have had years of undiagnosed diabetes and have a significant risk of prevalent diabetic retinopathy at the time of diagnosis should have an initial dilated and comprehensive eye examination at the time of diagnosis. Results of eye examinations should be documented and transmitted to the referring health care professional [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S44 160

Screening (2): If no evidence of retinopathy for one or more eye exam, exams every 2 years may be considered. B If diabetic retinopathy if present subsequent examinations for type 1 and type 2 diabetic patients should be repeated annually by an ophthalmologist or optometrist. B If retinopathy is progressing or sight- threatening, more frequent exams required. B Recommendations for the screening of retinopathy in patients with diabetes1 are summarized in four slides If there is no evidence of retinopathy for one or more eye exams, then exams every 2 years may be considered. If diabetic retinopathy is present, subsequent examinations for type 1 and type 2 diabetic patients should be repeated annually by an ophthalmologist or optometrist. If retinopathy is progressing or sight threatening, then examinations will be required more frequently Subsequent examinations for type 1 and type 2 diabetic patients are generally repeated annually Exams every 2 years may be cost effective after one or more normal eye exams, and in a population with well-controlled type 2 diabetes there was essentially no risk of development of significant retinopathy with a 3-year interval after a normal examination Examinations will be required more frequently if retinopathy is progressing [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S44–S45 Agardh E, Tababat-Khani P. Adopting 3-year screening intervals for sight threatening retinal vascular lesions in type 2 diabetic subjects without retinopathy. Diabetes Care 2011;34:1318–1319 161

Screening (3): High-quality fundus photographs can detect most clinically significant diabetic retinopathy. E Image interpretation should be performed by a trained eye care provider. E Retinal photography may serve as a screening tool for retinopathy, but is not a substitute for a comprehensive eye exam. E Perform comprehensive eye exam at least initially and at recommended intervals. E Recommendations for the screening of retinopathy in patients with diabetes1 are summarized in four slides High-quality fundus photographs can detect most clinically significant diabetic retinopathy. Interpretation of the images should be performed by a trained eye care provider While retinal photography may serve as a screening tool for retinopathy, it is not a substitute for a comprehensive eye exam, which should be performed at least initially and at intervals thereafter as recommended by an eye care professional Retinal photography ,with remote reading by experts, has great potential in areas where qualified eye care professionals are not available. It may also enhance efficiency and reduce costs when the expertise of ophthalmologists can be utilized for more complex examinations and for therapy In-person exams are still necessary when the photos are unacceptable and for follow-up of abnormalities detected Photos are not a substitute for a comprehensive eye exam, which should be performed at least initially and at intervals thereafter as recommended by an eye care professional Results of eye examinations should be documented and transmitted to the referring health care professional [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S45 Ahmed J, Ward TP, Bursell SE, Aiello LM, Cavallerano JD, Vigersky RA. The sensitivity and specificity of nonmydriatic digital stereoscopic retinal imaging in detecting diabetic retinopathy. Diabetes Care 2006;29:2205–2209 162

Screening (4): Women with preexisting diabetes who are planning pregnancy or who have become pregnant: B Counseled on risk of development and/or progression of diabetic retinopathy Eye examination should occur before pregnancy or in 1st trimester and quarterly for 1 year postpartum or as indicated by degree of retinopathy Pregnancy is associated with rapid progression of diabetic retinopathy, therefore women with preexisting type 1 or type 2 diabetes who are planning pregnancy or who have become pregnant should be counseled on the risk of its development and/or progression. Eye examinations should occur before pregnancy or in the first trimester and then be monitored every trimiseter and for 1 year [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S45 163

Treatment: Promptly refer patients with macular edema, severe NPDR, or any PDR to an ophthalmologist knowledgeable & experienced in management, treatment of diabetic retinopathy. A Laser photocoagulation therapy is indicated to reduce the risk of vision loss in patients with high-risk PDR and, in some cases, severe NPDR. A Promptly refer patients with any level of macular edema, severe nonproliferative diabetic retinopathy (NPDR) (a precursor of proliferative diabetic retinopathy), or any proliferative diabetic retinopathy (PDR) to an ophthalmologist who is knowledgeable and experienced in the management and treatment of diabetic retinopathy. Laser photocoagulation therapy is indicated to reduce the risk of vision loss in patients with high-risk PDR and, in some cases, severe NPDR. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S45 164

Treatment (2): Intravitreal injections of VEGF are indicated for center-involved diabetic macular edema, which occurs beneath the foveal center and which may threaten reading vision. A Retinopathy is not a contraindication to aspirin therapy for cardioprotection, as it does not increase the risk of retinal hemorrhage. A Intravitreal injections of antivascular endothelial growth factor (VEGF) are indicated for center-involved diabetic macular edema, which occurs beneath the foveal center and which may threaten reading vision. The presence of retinopathy is not a contraindication to aspirin therapy for cardioprotection, as aspirin does not increase the risk of retinal hemorrhage. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S45 165

Recommendations: Neuropathy
Early recognition & management is important because: DN is a diagnosis of exclusion. Numerous treatment options exist. Up to 50% of DPN may be asymptomatic. Recognition & treatment may improve symptoms, reduce seqeullae, and improve quality-of-life. The early recognition and appropriate management of neuropathy in the patient with diabetes is important because: Diabetic neuropathy is a diagnosis of exclusion. Nondiabetic neuropathies may be present in patients with diabetes and may be treatable. [CLICK] Numerous treatment options exist for symptomatic diabetic neuropathy. [CLICK] Up to 50% of DPN may be asymptomatic. If not recognized and if preventive foot care is not implemented (see below), patients are at risk for injuries to their insensate feet. [CLICK] Recognition and treatment of autonomic neuropathy may improve symptoms, reduce seqeullae, and improve quality-of-life. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S45 166

Recommendations: Neuropathy (2)
Screening: Assess all patients for DPN at dx for T2DM, 5 years after dx for T1DM, and at least annually thereafter. B Assessment should include history & 10g monofilament testing, and at least one of the following: pinprick, temperature, and vibration sensation. B Symptoms of autonomic neuropathy should be assessed in patients with microvascular & neuropathic complications. E Specific screening recommendations include: All patients should be assessed for diabetic peripheral neuropathy starting at diagnosis of type 2 diabetes and 5 years after the diagnosis of type 1 diabetes and at least annually thereafter. Assessment should include a careful history and 10-gram (g) monofilament testing, and at least one of the following tests: pinprick, temperature, and vibration sensation Symptoms and signs of autonomic neuropathy should be assessed in patients with microvascular and neuropathic complications. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S45 167

Recommendations: Neuropathy (3)
Treatment: Optimize glucose control to prevent or delay the development of neuropathy in patients with T1DM A & to slow progression in patients with T2DM. B Assess & treat patients to reduce pain related to DPN B and symptoms of autonomic neuropathy and to improve quality of life. E Near-normal glycemic control, implemented early in the course of diabetes, has been shown to effectively delay or prevent the development of DPN and cardiovascular autonomic diabetes in patients with type 1 diabetes. While the evidence for the benefit of near-normal glycemic control is not as strong for type 2 diabetes, some studies have demonstrated a modest slowing of progression without reversal of neuronal loss. Recommendations for treatment of neuropathy in patients with diabetes include: Optimize glucose control to prevent or delay the development of neuropathy in patients with type 1 diabetes and to slow the progression of neuropathy in patients with type 2 diabetes. [CLICK] Assess and treat patients to reduce pain related to DPN and symptoms of autonomic neuropathy and to improve quality of life. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S46 Ismail-Beigi F, Craven T, Banerji MA, et al for the ACCORD Trial Group. Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomised trial. Lancet 2010;376:419–430 Bril V, England J, Franklin GM, et al for the American Academy of Neurology; American Association of Neuromuscular and Electrodiagnostic Medicine; American Academy of Physical Medicine and Rehabilitation. Evidence-based guideline: treatment of painful diabetic neuropathy: report of the American Academy of Neurology, the American Association of Neuromuscular and Electrodiagnostic Medicine, and the American Academy of Physical Medicine and Rehabilitation. Neurology 2011;76:1758–1765 168

Recommendations: Foot Care
Perform a comprehensive foot evaluation annually to identify risk factors for ulcers & amputations. B History should contain prior hx of ulceration, amputation, Charcot foot, angioplasty or vascular surgery, cigarette smoking, retinopathy & renal disease; and should assess current symptoms of neuropathy and vascular disease. B For all patients with diabetes, perform a comprehensive foot evaluation each year to identify risk factors for ulcers and amputations. [CLICK] The history should obtain a prior history of ulceration, amputation, Charcot foot, angioplasty or vascular surgery, cigarette smoking, retinopathy and renal disease, and assess current symptoms of neuropathy (pain, burning, numbness) and vascular disease (leg fatigue, claudication). [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;36(suppl 1):S47–S48 169

Recommendations: Foot Care (2)
Exam should include inspection of the skin, assessment of foot deformities, neurologic assessment & vascular assessment including pulses in the legs and feet. B Patients with history of ulcers or amputations, foot deformities, insensate feet & PAD are at increased risk for ulcers and amputations and should have their feet examined at every visit. C • The examination should include inspection of the skin, assessment of foot deformities, neurologic assessment including 10-g monofilament testing and pinprick or vibration testing or assessment of ankle reflexes, and vascular assessment including pulses in the legs and feet. [CLICK] • Patients with history of ulcers or amputations, foot deformities, insensate feet, and peripheral arterial disease are at substantially increased risk for ulcers and amputations and should have their feet examined at every visit. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;36(suppl 1):S47–S48 170

Patients with symptoms of claudication, decreased, or absent pedal pulses should be referred for ABI & further vascular assessment. C A multidisciplinary approach is recommended for individuals with foot ulcers and high-risk feet. B Patients with symptoms of claudication, decreased, or absent pedal pulses should be referred for ankle-brachial index (ABI) and for further vascular assessment. [CLICK] A multidisciplinary approach is recommended for individuals with foot ulcers and high-risk feet (e.g., dialysis patients and those with Charcot foot, prior ulcers, or amputation). [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 171

Refer patients who smoke or who have hx of lower-extremity complications, loss of protective sensation, structural abnormalities or PAD to foot care specialists for ongoing preventive care and lifelong surveillance. C Provide general foot self-care education to all patients with diabetes. B Refer patients who smoke or who have histories of prior lower-extremity complications, a loss of protective sensation, structural abnormalities, or peripheral arterial disease to foot care specialists for ongoing preventive care and lifelong surveillance. [CLICK] Provide general foot self-care education to all patients with diabetes. Foot ulcers and amputation, which are consequences of diabetic neuropathy and/or peripheral arterial disease, are common and represent major causes of morbidity and mortality in people with diabetes. Early recognition and management of diabetes patients with feet at risk for ulcers and amputations can delay or prevent adverse outcomes. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Microvascular complications and foot care. Diabetes Care 2016; 39 (Suppl. 1): S72-S80 172

To perform the 10-g monofilament test, place the device perpendicular to the skin; Apply pressure until monofilament buckles. Hold in place for 1 second & release. The monofilament test should be performed at the highlighted sites while the patient’s eyes are closed. This slide illustrates how to perform the 10-g monofilament test Upper panel To perform the 10-g monofilament test, place the device perpendicular to the skin, with pressure applied until the monofilament buckles Hold in place for 1 second and then release Lower panel The monofilament test should be performed at the highlighted sites while the patient’s eyes are closed [SLIDE] Boulton A, Armstrong D, Albert, S et. al. Comprehensive Foot Examination and Risk Assessment. Diabetes Care ; 31: References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S39 Boulton AJ, Armstrong DG, Albert SF, et al., for the American Diabetes Association, American Association of Clinical Endocrinologists. Comprehensive foot examination and risk assessment: a report of the task force of the foot care interest group of the American Diabetes Association, with endorsement by the American Association of Clinical Endocrinologists. Diabetes Care 2008;31:1679–1685 173

Older Adults Section 10, diabetes care in older adults. [SLIDE] 174

Older Adults 26% of patients aged >65 have diabetes.
Older adults have higher rates of premature death, functional disability & coexisting illnesses. At greater risk for polypharmacy, cognitive impairment, urinary incontinence, injurious falls & persistent pain. Screening for complications should be individualized and periodically revisted. At higher risk for depression Diabetes is an important health condition for the aging population; approximately 26% of patients over the age of 65 years have diabetes (cdc.gov/diabetes), and this number is expected to grow rapidly in the coming decades. Older individuals with diabetes have higher rates of premature death, functional disability, and coexisting illnesses, such as hypertension, coronary heart disease, and stroke, than those without diabetes. Older adults with diabetes are also at a greater risk than other older adults for several common geriatric syndromes, such as polypharmacy, cognitive impairment, urinary incontinence, injurious falls, and persistent pain. Screening for diabetes complications in older adults also should be individualized and periodically revisited, since the results of screening tests may impact therapeutic approaches and targets. Older adults are at an increased risk for depression and should therefore be screened and treated accordingly. Diabetes management may require assessment of medical, functional, mental, and social domains. This may provide a framework to determine targets and therapeutic approaches. Particular attention should be paid to complications that can develop over short periods of time and/or that would significantly impair functional status, such as visual and lower- extremity complications. Please refer to the American Diabetes Association consensus report “Diabetes in Older Adults” for more information. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Older adults. Diabetes Care 2016; 39 (Suppl. 1): S81-S85 175

Recommendations: Older Adults
Functional, cognitively intact older adults (≥65 years of age) with significant life expectancy should receive diabetes care using goals developed for younger adults. E Determine targets & therapeutic approaches by assessment of medical, functional, mental, and social geriatric domains for diabetes management. E Older adults who are functional and cognitively intact and have significant life expectancy may receive diabetes care with goals similar to those developed for younger adults. Consider the assessment of medical, functional, mental, and social geriatric domains for diabetes management in older adults to provide a framework to determine targets and therapeutic approaches. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Older adults. Diabetes Care 2016; 39 (Suppl. 1): S81-S85 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S54-55 Kirkman M, Briscoe VJ, Clark N, et al. Diabetes in older adults. Diabetes Care 2012;35:2650–2664 176

Recommendations: Older Adults (2)
Glycemic goals for some older adults might be relaxed but hyperglycemia leading to symptoms or risk of acute hyperglycemic complications should be avoided in all patients. E Hypoglycemia should be avoided in older adults with diabetes. It should be screened for and managed by adjusting glycemic targets and pharmacologic interventions. B Glycemic goals for some older adults might reasonably be relaxed, using individual criteria, but hyperglycemia leading to symptoms or risk of acute hyperglycemic complications should be avoided in all patients. Hypoglycemia should be avoided in older adults with diabetes. It should be screened for and managed by adjusting glycemic targets and pharmacologic interventions. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Older adults. Diabetes Care 2016; 39 (Suppl. 1): S81-S85 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S54-55 Kirkman M, Briscoe VJ, Clark N, et al. Diabetes in older adults. Diabetes Care 2012;35:2650–2664 177

Patients with DM in long-term care facilities need careful assessment to establish a glycemic goal & to make appropriate choices of glucose-lowering agents. E Other CV risk factors should be treated in older adults with consideration of the time frame of benefit and the individual patient. E Treatment of HTN is indicated in virtually all older adults Lipid-lowering and aspirin therapy may benefit those with life expectancy at least equal to the time frame of primary or secondary prevention trials. Patients with diabetes residing in long-term care facilities need careful assessment to establish a glycemic goal and to make appropriate choices of glucose-lowering agents based on their clinical and functional status. Other cardiovascular risk factors should be treated in older adults with consideration of the time frame of benefit and the individual patient. Treatment of hypertension is indicated in virtually all older adults, and lipid-lowering and aspirin therapy may benefit those with life expectancy at least equal to the time frame of primary or secondary prevention trials. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Older adults. Diabetes Care 2016; 39 (Suppl. 1): S81-S85 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S54-55 Kirkman M, Briscoe VJ, Clark N, et al. Diabetes in older adults. Diabetes Care 2012;35:2650–2664 178

When palliative care is needed, strict BP control may not be necessary and withdrawal of therapy may be appropriate. Intensity of lipid management can be relaxed and withdrawal of lipid-lowering therapy may be appropriate. E Screening for complications should be individualized, but attention should be paid to complications that would lead to functional impairment. E When palliative care is needed in older adults with diabetes, strict blood pressure control may not be necessary, and withdrawal of therapy may be appropriate. Similarly, the intensity of lipid management can be relaxed, while withdrawal of lipid-lowering therapy may be appropriate. Screening for diabetes complications should be individualized in older adults, but particular attention should be paid to complications that would lead to functional impairment. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Older adults. Diabetes Care 2016; 39 (Suppl. 1): S81-S85 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S54-55 Kirkman M, Briscoe VJ, Clark N, et al. Diabetes in older adults. Diabetes Care 2012;35:2650–2664 179

Screening for geriatric syndromes may be appropriate in older adults with limitations in basic and instrumental activities of daily living. E Older adults with DM should be considered a high-priority population for depression screening and treatment. B Screening for geriatric syndromes may be appropriate in older adults experiencing limitations in their basic and instrumental activities of daily living, as they may affect diabetes self- management. Older adults (≥65 years of age) with diabetes should be considered a high-priority population for depression screening and treatment. Consider diabetes education for the staff of long-term care facilities to improve the management of older adults with diabetes. Overall comfort, prevention of distressing symptoms, and preservation of quality of life and dignity are primary goals for diabetes management at the end of life. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Older adults. Diabetes Care 2016; 39 (Suppl. 1): S81-S85 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S54-55 Kirkman M, Briscoe VJ, Clark N, et al. Diabetes in older adults. Diabetes Care 2012;35:2650–2664 180

Consider diabetes education for long- term care facility staff. E Overall comfort, prevention of distressing symptoms & preservation of quality of life and dignity are primary goals for diabetes management at the end of life. E Consider diabetes education for the staff of long-term care facilities to improve the management of older adults with diabetes. Overall comfort, prevention of distressing symptoms, and preservation of quality of life and dignity are primary goals for diabetes management at the end of life. The full 2016 Standards of Medical Care in Diabetes also include several strata have been developed and proposed to help guide management of older adults in hospice and palliative care, which we won’t go through here. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Older adults. Diabetes Care 2016; 39 (Suppl. 1): S81-S85 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S54-55 Kirkman M, Briscoe VJ, Clark N, et al. Diabetes in older adults. Diabetes Care 2012;35:2650–2664 181

Children & Adolescents
Section 11, Children and Adolescents. [SLIDE] 182

Type 1 Diabetes ¾ of all cases of T1DM are dx’d in patients <18 yrs. Providers must consider many unique aspects to care & mgmt. of children & adolescents with T1DM. Attention to family dynamics, developmental stages, physiological differences is essential. Recommendations less likely to be based on clinical trial evidence. Three-quarters of all cases of type 1 diabetes are diagnosed in individuals <18 years of age. The provider must consider the unique aspects of care and management of children and adolescents with type 1 diabetes, such as changes in insulin sensitivity related to physical growth and sexual maturation, ability to provide self-care, supervision in the child care and school environment, and neurological vulnerability to hypoglycemia and hyperglycemia in young children as well as possible adverse neurocognitive effects of diabetic ketoacidosis Attention to family dynamics, developmental stages, and physiological differences related to sexual maturity are all essential in developing and implementing an optimal diabetes regimen Due to the paucity of clinical research in children, the recommendations for children and adolescents are less likely to be based on clinical trial evidence. However, expert opinion and a review of available and relevant experimental data are summarized in the American Diabetes Association (ADA) position statement “Care of Children and Adolescents With Type 1 Diabetes” and have been updated in the recently published ADA position statement “Type 1 Diabetes Through the Life Span.” [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 183

Type 1 Diabetes: DSME & DSMS
Youth w/ T1DM & parents/caregivers should receive culturally sensitive & developmentally appropriate individualized DSME and DSMS according to national standards at diagnosis and routinely thereafter. B Youth with type 1 diabetes and parents/caregivers (for patients aged <18 years) should receive culturally sensitive and developmentally appropriate individualized DSME and DSMS according to national standards at diagnosed and routinely thereafter. No matter how sound the medical regimen, it can only be effective if the family and/or affected individual are able to implement it. Family involvement is a vital component of optimal diabetes management throughout childhood and adolescence. Health care providers (the diabetes care team) who care for children and adolescents must be capable of evaluating the educational, behavioral, emotional, and psychosocial factors that impact implementation of a treatment plan and must work with the individual and family to overcome barriers or redefine goals as appropriate. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 184

Type 1 Diabetes: Psychosocial Issues
At diagnosis and during routine follow-up care, assess psychosocial issues and family stresses that could impact adherence to diabetes mgmt. Provide referrals to trained mental health professionals, preferably experienced in childhood diabetes, as appropriate. E There are three recommendations in the area of psychosocial issues: First, at diagnosis and during routine follow-up care, assess psychosocial issues and family stresses that could impact adherence to diabetes mgmt. Provide referrals to trained mental health professionals, preferably experienced in childhood diabetes, as appropriate. E [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 185

Type 1 Diabetes: Psychosocial Issues (2)
Encourage family involvement in diabetes mgmt. tasks for children & adolescents, as premature transfer of diabetes care can result in nonadherence and deterioration in glycemic control. B Consider mental health professionals as an integral member of the pediatric diabetes multidisciplinary team. E Second, encourage developmentally appropriate family involvement in diabetes mgmt. tasks for children and adolescents, recognizing that premature transfer of diabetes care to the child can result in nonadherence and deterioration in glycemic control. And finally, consider mental health professionals as an integral member of the pediatric diabetes multidisciplinary team. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 186

Type 1 Diabetes: Glycemic Control
An A1C goal of <7.5% is recommended across all pediatric age-groups. E • An A1C goal of <7.5% is recommended across all pediatric age-groups. Current standards for diabetes management reflect the need to lower glucose as safely as possible. This should be done with stepwise goals. Special consideration should be given to the risk of hypoglycemia in young children (aged <6 years) who are often unable to recognize, articulate, and/or manage their hypoglycemic symptoms. This “hypoglycemia unawareness” should be considered when establishing individualized glycemic targets. Although it was previously thought that young children were at risk for cognitive impairment after episodes of severe hypoglycemia, current data have not confirmed this notion. Furthermore, new therapeutic modalities, such as rapid- and long-acting insulin analogs, technological advances (e.g., continuous glucose monitors, low glucose suspend insulin pumps), and education, may mitigate the incidence of severe hypoglycemia [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 187

Type 1 Diabetes: Glycemic Control
Blood glucose goal range A1C Rationale Before meals Bedtime/ overnight 90–130 mg/dL (5.0–7.2 mmol/L) 90–150 mg/dL (5.0–8.3 mmol/L) <7.5% A lower goal (<7.0%) is reasonable if it can be achieved without excessive hypos Goals should be individualized; lower goals may be reasonable. Modify BG goals in youth w/ frequent hypos or hypoglycemia unawareness. Measure postprandial BG if discrepancy between preprandial BG and A1C & to assess glycemia in basal–bolus regimens. This is Table 11.1, Blood glucose and A1C goals for type 1 diabetes across all pediatric age- groups. With these goals it is essential to keep in mind three key concepts: [CLICK] Goals should be individualized, and lower goals may be reasonable based on benefit-risk assessment. [CLICK] Blood glucose goals should be modified in children with frequent hypoglycemia or hypoglycemia unawareness. [CLICK] Postprandial blood glucose values should be measured when there is a discrepancy between preprandial blood glucose values and A1C levels and to help assess glycemia in those on basal–bolus regimens. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S50 Seaquist ER, Anderson J, Childs B, et al. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and The Endocrine Society. Diabetes Care 2013;36:1384–1395 Wysocki T, Harris MA, Mauras N, et al. Absence of adverse effects of severe hypoglycemia on cognitive function in school-aged children with diabetes over 18 months. Diabetes Care 2003;26:1100–1105 Blasetti A, Chiuri RM, Tocco AM, et al. The effect of recurrent severe hypoglycemia on cognitive performance in children with type 1 diabetes: a metaanalysis. J Child Neurol 2011;26:1383–1391 Cooper MN, O’Connell SM, Davis EA, Jones TW. A population-based study of risk factors for severe hypoglycaemia in a contemporary cohort of childhood-onset type 1 diabetes. Diabetologia 2013;56:2164–2170 188

Type 1 Diabetes: Thyroid Disease
Consider testing children with T1DM for antithyroid peroxidase and antithyroglobulin antibodies soon after diagnosis. E Measure thyroid stimulating hormone concentrations soon after diagnosis of T1DM & glucose control has been established. If normal, consider rechecking every 1–2 yrs or sooner if patient develops symptoms suggestive of thyroid dysfunction, thyromegaly, an abnormal growth rate, or unexplained glycemic variation. E Consider testing children with type 1 diabetes for antithyroid peroxidase and antithyroglobulin antibodies soon after diagnosis. Measure thyroid stimulating hormone concentrations soon after diagnosis of type 1 diabetes and glucose control has been established. If normal, consider rechecking every 1–2 years or sooner if the patient develops symptoms suggestive of thyroid dysfunction, thyromegaly, an abnormal growth rate, or unexplained glycemic variation. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 189

Type 1 Diabetes: Celiac Disease
Consider screening children with T1DM for celiac disease soon after the diagnosis of diabetes. E Consider screening in children who have a first degree relative with celiac disease, growth failure, weight loss, failure to gain weight, diarrhea, flatulence, abdominal pain, or signs of malabsorption, or in children with frequent unexplained hypoglycemia or deterioration in glycemic control. E Celiac disease is an immune-mediated disorder that occurs with increased frequency in patients with type 1 diabetes (1.6–16.4% of individuals compared with 0.3–1% in the general population) Consider screening children with type 1 diabetes for celiac disease by measuring either tissue transglutaminase or deamidated gliadin antibody, with documentation of normal total serum IgA levels, soon after the diagnosis of diabetes. Consider screening in children who have a first degree relative with celiac disease, growth failure, weight loss, failure to gain weight, diarrhea, flatulence, abdominal pain, or signs of malabsorption, or in children with frequent unexplained hypoglycemia or deterioration in glycemic control. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 190

Type 1 Diabetes: Celiac Disease (2)
Children with biopsy-confirmed celiac disease should be placed on a gluten-free diet and have a consultation with a dietitian experienced in managing both diabetes and celiac disease. B Children with biopsy-confirmed celiac disease should be placed on a gluten-free diet and have a consultation with a dietitian experienced in managing both diabetes and celiac disease. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 191

Type 1 Diabetes: Hypertension
Screening: Measure BP at each routine visit. Children found to have high-normal blood pressure (SBP or DBP ≥90th percentile for age, sex, and height) or hypertension (SBP or DBP ≥95th percentile for age, sex, and height) should have blood pressure confirmed on three separate days. B Blood pressure should be measured at each routine visit. Children found to have high-normal blood pressure, which is defined as either systolic blood pressure or diastolic blood pressure ≥90th percentile for age, sex, and height, or hypertension should have blood pressure confirmed on three separate days. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 192

Type 1 Diabetes: Hypertension (2)
Treatment: Initial treatment of high-normal BP (SBP or DBP consistently ≥90th percentile for age, sex, and height) includes dietary modification and increased exercise, if appropriate, aimed at weight control. If target blood pressure is not reached with 3–6 months of initiating lifestyle intervention, consider pharmacological treatment. E In addition to lifestyle modification, pharmacological treatment of HTN should be considered as soon as HTN is confirmed. E Initial treatment of high-normal blood pressure includes dietary modification and increased exercise, if appropriate, aimed at weight control. If target blood pressure is not reached with 3–6 months of initiating lifestyle intervention, pharmacological treatment should be considered. In addition to lifestyle modification, pharmacological treatment of hypertension should be considered as soon as hypertension is confirmed. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 193

Type 1 Diabetes: Hypertension (3)
Treatment (2): Consider ACE inhibitors or ARBs for the initial pharmacological treatment of HTN, following reproductive counseling due to the potential teratogenic effects of both drug classes. E The goal of treatment is blood pressure consistently <90th percentile for age, sex, and height. E ACE inhibitors or ARBs should be considered for the initial pharmacological treatment of hypertension, following reproductive counseling due to the potential teratogenic effects of both drug classes. The goal of treatment is blood pressure consistently <90th percentile for age, sex, and height. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 194

Type 1 Diabetes: Dyslipidemia
Testing: Obtain a fasting lipid profile in children ≥10 years of age soon after the diagnosis (after glucose control has been established). E If lipids are abnormal, annual monitoring is reasonable. If LDL values are <100 mg/dL, a lipid profile every 3- 5 years is reasonable. E Obtain a fasting lipid profile in children ≥10 years of age soon after the diagnosis (after glucose control has been established). If lipids are abnormal, annual monitoring is reasonable. If LDL cholesterol values are within the accepted risk level (<100 mg/dL [2.6 mmol/L]), a lipid profile repeated every 3-5 years is reasonable. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S51 Hörtenhuber T, Rami-Mehar B, Satler M, et al. Endothelial progenitor cells are related to glycemic control in children with type 1 diabetes over time. Diabetes Care 2013;36:1647–1653 Haller MJ, Samyn M, Nichols WW, et al. Radial artery tonometry demonstrates arterial stiffness in children with type 1 diabetes. Diabetes Care 2004;27:2911–2917 Orchard TJ, Forrest KY, Kuller LH, Becker DJ, for the Pittsburgh Epidemiology of Diabetes Complications Study. Lipid and blood pressure treatment goals for type 1 diabetes: 10-year incidence data from the Pittsburgh Epidemiology of Diabetes Complications Study. Diabetes Care 2001;24:1053–1059 195

Type 1 Diabetes: Dyslipidemia
Treatment: Initial therapy: Optimize glucose control & MNT using a Step 2 American Heart Association diet to decrease the amount of saturated fat in the diet. After age 10, addition of a statin is suggested in patients who, despite MNT & lifestyle changes, continue to have LDL cholesterol >160 mg/dL (4.1 mmol/L) or LDL cholesterol >130 mg/dL (3.4 mmol/L) and one or more CVD risk factors. Goal of therapy is LDL <100 mg/dL. Initial therapy should consist of optimizing glucose control and MNT using a Step 2 American Heart Association diet to decrease the amount of saturated fat in the diet. Although intervention data are sparse, the AHA categorizes children with type 1 diabetes in the highest tier for cardiovascular risk and recommends both lifestyle and pharmacological treatment for those with elevated LDL cholesterol levels. Initial therapy should be with a Step 2 AHA diet, which restricts saturated fat to 7% of total calories and restricts dietary cholesterol to 200 mg/day. After the age of 10 years, addition of a statin is suggested in patients who, despite MNT and lifestyle changes, continue to have LDL cholesterol >160 mg/dL or LDL cholesterol >130 mg/dL and one or more cardiovascular disease risk factors. The goal of therapy is an LDL cholesterol value <100 mg/dL. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S51 Hörtenhuber T, Rami-Mehar B, Satler M, et al. Endothelial progenitor cells are related to glycemic control in children with type 1 diabetes over time. Diabetes Care 2013;36:1647–1653 Haller MJ, Samyn M, Nichols WW, et al. Radial artery tonometry demonstrates arterial stiffness in children with type 1 diabetes. Diabetes Care 2004;27:2911–2917 Orchard TJ, Forrest KY, Kuller LH, Becker DJ, for the Pittsburgh Epidemiology of Diabetes Complications Study. Lipid and blood pressure treatment goals for type 1 diabetes: 10-year incidence data from the Pittsburgh Epidemiology of Diabetes Complications Study. Diabetes Care 2001;24:1053–1059 196

Type 1 Diabetes: Smoking
Elicit a smoking history at initial and follow- up diabetes visits and discourage smoking in youth who do not smoke and encourage smoking cessation in those who do. B As in adults with diabetes and the population as a whole, discourage smoking in youth who do not smoke and encourage smoking cessation in those who do. Elicit a smoking history at initial and follow-up diabetes visits. The adverse health effects of smoking are well recognized with respect to future cancer and CVD risk. In youth with diabetes, it is important to avoid additional CVD risk factors. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S51 Hörtenhuber T, Rami-Mehar B, Satler M, et al. Endothelial progenitor cells are related to glycemic control in children with type 1 diabetes over time. Diabetes Care 2013;36:1647–1653 Haller MJ, Samyn M, Nichols WW, et al. Radial artery tonometry demonstrates arterial stiffness in children with type 1 diabetes. Diabetes Care 2004;27:2911–2917 Orchard TJ, Forrest KY, Kuller LH, Becker DJ, for the Pittsburgh Epidemiology of Diabetes Complications Study. Lipid and blood pressure treatment goals for type 1 diabetes: 10-year incidence data from the Pittsburgh Epidemiology of Diabetes Complications Study. Diabetes Care 2001;24:1053–1059 197

Type 1 Diabetes: Nephropathy
Screening: Annual screening for albuminuria with a random spot urine sample for albumin-to-creatinine ratio (UACR), should be considered once the child has had diabetes for 5 years. B Estimate glomerular filtration rate at initial evaluation and then based on age, diabetes duration & treatment. E Annual screening for albuminuria with a random spot urine sample for albumin-to-creatinine ratio (UACR), should be considered once the child has had diabetes for 5 years. Estimate glomerular filtration rate at initial evaluation and then based on age, diabetes duration, and treatment. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 198

Type 1 Diabetes: Nephropathy
Treatment: Consider an ACE inhibitor, titrated to normalization of albumin excretion, when elevated UACR (>30 mg/g) is documented with at least 2 of 3 urine samples. Obtain these over a 6-month interval following efforts to improve glycemic control and normalize blood pressure. B As far as treatment of nephropathy, consider an ACE inhibitor, titrated to normalization of albumin excretion, when elevated UACR (>30 mg/g) is documented with at least two of three urine samples. These should be obtained over a 6-month interval following efforts to improve glycemic control and normalize blood pressure. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 199

Type 1 Diabetes: Retinopathy
An initial dilated & comprehensive eye exam is recommended at age ≥10 years or after puberty has started, whichever is earlier, once the youth has had diabetes for 3–5 years. B After the initial exam, annual follow- up is recommended. Less frequent exams, every 2 years, may be acceptable on the advice of an eye care professional. E An initial dilated and comprehensive eye examination is recommended at age ≥10 years or after puberty has started, whichever is earlier, once the youth has had diabetes for 3–5 years. After the initial examination, annual routine follow-up is generally recommended. Less frequent examinations, every 2 years, may be acceptable on the advice of an eye care professional. Although retinopathy (like albuminuria) most commonly occurs after the onset of puberty and after 5–10 years of diabetes duration (60), it has been reported in prepubertal children and with diabetes duration of only 1–2 years. Referrals should be made to eye care professionals with expertise in diabetic retinopathy and experience in counseling the pediatric patient and family on the importance of early prevention/intervention. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 200

Type 1 Diabetes: Neuropathy
Consider an annual comprehensive foot exam at the start of puberty or at age ≥10 years, whichever is earlier, once the youth has had type 1 diabetes for 5 years. E Consider an annual comprehensive foot exam for the child at the start of puberty or at age ≥10 years, whichever is earlier, once the youth has had type 1 diabetes for 5 years. Neuropathy rarely occurs in prepubertal children or after only 1–2 years of diabetes (60). A comprehensive foot exam, including inspection, palpation of dorsalis pedis and posterior tibial pulses, assessment of the patellar and Achilles reflexes, and determination of proprioception, vibration, and monofilament sensation, should be performed annually along with assessment of symptoms of neuropathic pain. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 201

Type 2 Diabetes Distinguishing between type 1 and type 2 can be challenging. Excessive weight is common in type 1. Diabetes-associated autoantibodies and ketosis may be present in patients with features of type 2 such as obesity and AN). Accurate diagnosis is critical. We covered information on screening and testing for type 2 diabetes in children & adolescents earlier, so now we’ll focus on treatment. Given the current obesity epidemic, distinguishing between type 1 and type 2 diabetes in children can be difficult. For example, excessive weight is common in children with type 1 diabetes. Furthermore, diabetes-associated autoantibodies and ketosis may be present in patients with features of type 2 diabetes (including obesity and acanthosis nigricans) (64). Nevertheless, accurate diagnosis is critical as treatment regimens, educational approaches, dietary advice, and outcomes differ markedly between the two diagnoses. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 202

Type 2 Diabetes (2) Comorbidities may be present at time of diagnosis.
At diagnosis, perform: BP measurement Fasting lipid panel Assessment for albumin excretion Dilated eye exam Other screening & treatment recommendations similar to T1DM. Comorbidities may be present at time of diagnosis in youth with type 2 diabetes. Therefore, blood pressure measurement, a fasting lipid panel, assessment for albumin excretion, and a dilated eye examination should be performed at diagnosis. Thereafter, screening guidelines and treatment recommendations for hypertension, dyslipidemia, albumin excretion, and retinopathy are similar to those for youth with type 1 diabetes. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 203

Type 2 Diabetes (3) Additional problems may include:
PCOS Sleep apnea Hepatic steatosis Orthopedic complications Psychosocial concerns ADA consensus report on Type 2 Diabetes in Children & Adolescents AAP Clinical Practice Guideline Additional problems that may need to be addressed include polycystic ovary disease and other comorbidities associated with pediatric obesity, such as sleep apnea, hepatic steatosis, orthopedic complications, and psychosocial concerns. There is an ADA consensus report on Type 2 Diabetes in Children and Adolescents and a more recent American Academy of Pediatrics Clinical Practice Guideline on the topic, both of which provide guidance on the prevention, screening, and treatment of type 2 diabetes and its comorbidities in children and adolescents. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 204

Recommendations: Transition from Pediatric to Adult Care
Health care providers and families should begin to prepare youth in early to mid-adolescence and, at the latest, at least 1 year before the transition to adult health care. E Both pediatricians and adult health care providers should assist in providing support and links to resources for the teen and emerging adult. B Care and close supervision of diabetes management is increasingly shifted from parents and other older adults throughout childhood and adolescence; however, the shift from pediatric to adult health care providers often occurs very abruptly as the older teen enters the next developmental stage, referred to as emerging adulthood,1 a critical period for young people who have diabetes Health care providers and families should begin to prepare youth in early to mid-adolescence and, at the latest, at least 1 year before the transition to adult health care. Both pediatricians and adult health care providers should assist in providing support and links to resources for the teen and emerging adult. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 References Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol 2000;55:469–480 Weissberg-Benchell J, Wolpert H, Anderson BJ. Transitioning from pediatric to adult care: a new approach to the post-adolescent young person with type 1 diabetes. Diabetes Care 2007;30:2441–2446 Peters A, Laffel L, for the American Diabetes Association Transitions Working Group. Diabetes care for emerging adults: recommendations for transition from pediatric to adult diabetes care systems: a position statement of the American Diabetes Association, with representation by other groups. Diabetes Care 2011;34:2477–2485 American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S53 205

Recommendations: Transition from Pediatric to Adult Care (2)
Early & ongoing attention should be given to comprehensive coordinated planning for seamless transition of all youth to adult health care. Association position statement, “Diabetes Care for Emerging Adults” NDEP: Endocrine Society: Though scientific evidence continues to be limited, it is clear that early and ongoing attention be given to comprehensive coordinated planning for seamless transition of all youth from pediatric to adult health care A comprehensive discussion regarding the challenges faced during this period is found in the ADA position statement “Diabetes Care for Emerging Adults: Recommendations for the Transition from Pediatric to Adult Diabetes Care Systems” The National Diabetes Education Program (NDEP) has materials available to facilitate the transition process ( and The Endocrine Society in collaboration with the ADA and other organizations has developed transition tools for clinicians and youth/families and those are available at endocrine.org ( society.org/clinicalpractice/transition_of_care.cfm ) [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Children and adolescents. Diabetes Care 2016; 39 (Suppl. 1): S86-S93 References Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol 2000;55:469–480 Weissberg-Benchell J, Wolpert H, Anderson BJ. Transitioning from pediatric to adult care: a new approach to the post-adolescent young person with type 1 diabetes. Diabetes Care 2007;30:2441–2446 Peters A, Laffel L, for the American Diabetes Association Transitions Working Group. Diabetes care for emerging adults: recommendations for transition from pediatric to adult diabetes care systems: a position statement of the American Diabetes Association, with representation by other groups. Diabetes Care 2011;34:2477–2485 American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S53 206

Management of Diabetes in Pregnancy
Section 12: Management of Diabetes in Pregnancy This section will cover the management of diabetes in pregnancy; Guidelines related to the diagnosis of GDM were covered earlier, in Classification and Diagnosis of Diabetes. 207

Pregestational Diabetes
Provide preconception counseling that addresses the importance of tight glycemic control, ideally <6.5%, to reduce the risk of congenital anomalies. B Family planning should be discussed and effective contraception should be prescribed and used until a woman is prepared and ready to become pregnant. A Recommendations for the preconception care of women with diabetes are summarized in two slides: Provide preconception counseling that addresses the importance of glycemic control as close to normal as is safely possible, ideally <6.5%, to reduce the risk of congenital anomalies. Family planning should be discussed and effective contraception should be prescribed and used until a woman is prepared and ready to become pregnant. [SLIDE] American Diabetes Association. Management of diabetes in pregnancy. Standards of Medical Care in Diabetes Diabetes Care 2016;39(Suppl. 1):S94–S98 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S53–S54 208

Pregestational Diabetes (2)
Women w/ preexisting type 1 or type 2 diabetes who are pregnant or planning to become pregnant should be counseled on the risk of development and/or progression of diabetic retinopathy. Eye exams should occur before pregnancy or in the first trimester & then be monitored every trimester and for 1 year postpartum as indicated by degree of retinopathy. B Women with preexisting type 1 or type 2 diabetes who are planning pregnancy or who have become pregnant should be counseled on the risk of development and/or progression of diabetic retinopathy. Eye examinations should occur before pregnancy or in the first trimester and then be monitored every trimiseter and for 1 year postpartum as indicated by degree of retinopathy. [SLIDE] American Diabetes Association. Management of diabetes in pregnancy. Standards of Medical Care in Diabetes Diabetes Care 2016;39(Suppl. 1):S94–S98 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S53–S54 209

Gestational Diabetes Mellitus (GDM)
Lifestyle change is an essential part GDM mgmt. and may suffice for many women. Add medications if needed to achieve glycemic targets. A Preferred medications in GDM are insulin and metformin; glyburide may be used but may have higher rate of neonatal hypoglycemia & macrosomia than insulin or metformin. Other agents have not been adequately studied. Most oral agents cross the placenta and all lack long-term safety data. A Recommendations for care of women with gestational diabetes include the following: Lifestyle change is an essential part GDM mgmt. and may suffice for many women. Add medications if needed to achieve glycemic targets. Preferred medications in GDM are insulin and metformin; glyburide may be used but may have higher rate of neonatal hypoglycemia & macrosomia than insulin or metformin. Other agents have not been adequately studied. Most oral agents cross the placenta and all lack long- term safety data. [SLIDE] American Diabetes Association. Management of diabetes in pregnancy. Standards of Medical Care in Diabetes Diabetes Care 2016;39(Suppl. 1):S94–S98 210

General Principles for Management of Diabetes in Pregnancy
Potentially teratogenic medications (ACE inhibitors, statins, etc.) should be avoided in sexually active women of childbearing age who are not using reliable contraception. B Fasting, preprandial & postprandial SMBG are recommended in both GDM and pregestational diabetes in pregnancy to achieve glycemic control. B And finally, recommendations on general principles for management of diabetes in pregnancy are summarized here and on the following slide: Potentially teratogenic medications (ACE inhibitors, statins, etc.) should be avoided in sexually active women of childbearing age who are not using reliable contraception. Fasting, preprandial & postprandial SMBG are recommended in both gestational and pregestational diabetes in pregnancy to achieve glycemic control. [SLIDE] American Diabetes Association. Management of diabetes in pregnancy. Standards of Medical Care in Diabetes Diabetes Care 2016;39(Suppl. 1):S94–S98 211

General Principles for Management of Diabetes in Pregnancy (2)
Due to increased red blood cell turnover, A1C is lower in normal pregnancy than in normal nonpregnant women. A1C target in pregnancy is 6 – 6.5% (42– 48mmol/mol); <6% (42 mmol/mol) may be optimal if achievable without significant hypoglycemia, but the target may be relaxed to <7% (53 mmol/mol) if necessary to prevent hypoglycemia. B Due to increased red blood cell turnover, A1C is lower in normal pregnancy than in normal nonpregnant women. The A1C target in pregnancy is 6 – 6.5%. Less than 6% may be optimal if you can achieve it without significant hypoglycemia, but the target may be relaxed to less than 7% if necessary to prevent hypoglycemia. [SLIDE] American Diabetes Association. Management of diabetes in pregnancy. Standards of Medical Care in Diabetes Diabetes Care 2016;39(Suppl. 1):S94–S98 212

Glycemic Targets in Pregnancy (Preexisting Type 1 or Type 2)
The American College of Obstetricians and Gynecologists (ACOG) recommends the following targets for women with pregestational type 1 or type 2 diabetes: Fasting ≤90 mg/dL (5.0 mmol/L) One-hour postprandial ≤130–140mg/dL (7.2–7.8 mmol/L) Two-hour postprandial ≤120 mg/dL (6.7 mmol/L) In women with pregestational, or pre-existing type 1 or type 2 diabetes, the American College of Obstetricians and Gynecologists recommends the following targets: Fasting ≤90 mg/dL One-hour postprandial ≤130–140mg/dL Two-hour postprandial ≤120 mg/dL [SLIDE] American Diabetes Association. Management of diabetes in pregnancy. Standards of Medical Care in Diabetes Diabetes Care 2016;39(Suppl. 1):S94–S98 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S54 Kitzmiller JL, Block JM, Brown FM, et al. Managing preexisting diabetes for pregnancy: summary of evidence and consensus recommendations for care. Diabetes Care 2008;31:1060–1079 American Diabetes Association. Preconception care of women with diabetes. Diabetes Care 2004;27(Suppl. 1):S76–S78 213

Glycemic Targets in GDM
For women with gestational diabetes, the following targets are recommended by the Fifth International Workshop- Conference on Gestational Diabetes Mellitus: Fasting ≤95 mg/dL (5.3 mmol/L) and either One-hour postprandial ≤140 mg/dL (7.8 mmol/L) or Two-hour postprandial ≤120 mg/dL (6.7 mmol/L) And for your patients with gestational diabetes, not preexisting type 1 or type 2 diabetes, these targets are recommended by the Fifth International Workshop-Conference on Gestational Diabetes Mellitus: Fasting ≤95 mg/dL and either One-hour postprandial ≤140 mg/dL or Two-hour postprandial ≤120 mg/dL But it’s important to note that the American Diabetes Association recommends setting targets based on clinical experience, individualizing care as needed. [SLIDE] American Diabetes Association. Management of diabetes in pregnancy. Standards of Medical Care in Diabetes Diabetes Care 2016;39(Suppl. 1):S94–S98 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S54 Kitzmiller JL, Block JM, Brown FM, et al. Managing preexisting diabetes for pregnancy: summary of evidence and consensus recommendations for care. Diabetes Care 2008;31:1060–1079 American Diabetes Association. Preconception care of women with diabetes. Diabetes Care 2004;27(Suppl. 1):S76–S78 214

Diabetes Care in the Hospital
Section 13: Diabetes Care in the Hospital [SLIDE] 215

Recommendations: Diabetes Care in the Hospital
Consider getting an A1C on all patients with diabetes or hyperglycemia admitted to the hospital if not performed in the prior 3 months. C Start insulin therapy for persistent hyperglycemia starting at a threshold ≥180 mg/dL (10 mmol/L). Then a target glucose of 140–180 mg/dL (7.8–10 mmol/L) is recommended for the majority of critically ill A and noncritically ill patients. C Recommendations for diabetes care in the hospital include: Consider performing an A1C on all patients with diabetes or hyperglycemia admitted to the hospital if not performed in the prior 3 months. Insulin therapy should be initiated for treatment of persistent hyperglycemia starting at a threshold $180 mg/dL. Once insulin therapy is started, a target glucose range of 140–180 mg/dL is recommended for the majority of critically ill patients and noncritically ill patients. [SLIDE] American Diabetes Association. Diabetes care in the hospital. Standards of Medical Care in Diabetes Diabetes Care 2016;39(Suppl. 1):S94–S98 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S56–S57 216

Recommendations: Diabetes Care in the Hospital (2)
More stringent goals, such as 110– 140 mg/dL (6.1–7.8 mmol/L) may be appropriate for selected critically ill patients, if achievable without significant hypoglycemia. C Intravenous insulin infusions should be administered using validated protocols that allow for predefined adjustments in the infusion rate based on glycemic fluctuations and insulin dose. E More stringent goals, such as 110–140 mg/dL may be appropriate for selected critically ill patients, as long as this can be achieved without significant hypoglycemia. Intravenous insulin infusions should be administered using validated written or computerized protocols that allow for predefined adjustments in the insulin infusion rate based on glycemic fluctuations and insulin dose. [SLIDE] American Diabetes Association. Diabetes care in the hospital. Standards of Medical Care in Diabetes Diabetes Care 2016;39(Suppl. 1):S94–S98 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S56–S57 217

A basal + bolus correction regimen is the preferred treatment for noncritically ill patients with poor oral intake or those who are NPO. An insulin regimen with basal, nutritional & correction components is the preferred treatment for patients with good nutritional intake. A The sole use of sliding scale insulin in the inpatient hospital setting is strongly discouraged. A A basal plus bolus correction insulin regimen is the preferred treatment for noncritically ill patients with poor oral intake or those who are taking nothing by mouth. An insulin regimen with basal, nutritional, and correction components is the preferred treatment for patients with good nutritional intake. The sole use of sliding scale insulin in the inpatient hospital setting is strongly discouraged. [SLIDE] American Diabetes Association. Diabetes care in the hospital. Standards of Medical Care in Diabetes Diabetes Care 2016;39(Suppl. 1):S94–S98 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S56–S57 218

A hypoglycemia management protocol should be adopted and implemented by each hospital or hospital system. E A plan for preventing and treating hypoglycemia should be established for each patient. E Episodes of hypoglycemia in the hospital should be documented in the medical record and tracked. E A hypoglycemia management protocol should be adopted and implemented by each hospital or hospital system. A plan for preventing and treating hypoglycemia should be established for each patient, and episodes of hypoglycemia in the hospital should be documented in the medical record and tracked. [SLIDE] American Diabetes Association. Diabetes care in the hospital. Standards of Medical Care in Diabetes Diabetes Care 2016;39(Suppl. 1):S94–S98 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S56–S57 219

The treatment regimen should be reviewed and changed if necessary to prevent further hypoglycemia when a blood glucose value is <70 mg/dL (3.9 mmol/L). C There should be a structured discharge plan tailored to the individual patient. B The treatment regimen should be reviewed and changed if necessary to prevent further hypoglycemia when a blood glucose value is <70 mg/dL. And finally, There should be a structured discharge plan tailored to the individual patient. [SLIDE] American Diabetes Association. Diabetes care in the hospital. Standards of Medical Care in Diabetes Diabetes Care 2016;39(Suppl. 1):S94–S98 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S56–S57 220

Diabetes Advocacy Managing the daily health demands of diabetes can be challenging. People living with diabetes should not have to face additional discrimination due to diabetes. By advocating for the rights of those with diabetes at all levels, the American Diabetes Association can help to ensure that they live a healthy and productive life. A strategic goal of the ADA is that more children and adults with diabetes live free from the burden of discrimination. [SLIDE] 221

Advocacy Position Statements
ADA publishes evidence-based, peer- reviewed statements including: Diabetes and employment Diabetes and driving Diabetes management in schools, child care programs, and correctional institutions. These are important tools in educating: Schools Employers Licensing agencies Policy makers Professional.diabetes.org/SOC One tactic for achieving this goal is to implement the ADA’s Standards of Medical Care through advocacy-oriented position statements. The ADA publishes evidence-based, peer- reviewed statements on topics such as diabetes and employment, diabetes and driving, and diabetes management in certain settings such as schools, child care programs, and correctional institutions. In addition to ADA’s clinical position statements, these advocacy position statements are important tools in educating schools, employers, licensing agencies, policymakers, and others about the intersection of diabetes medicine and the law. These can all be downloaded from the Association’s web site at professional dot diabetes dot org slash SOC. {SLIDE] American Diabetes Association. Diabetes advocacy. Standards of Medical Care in Diabetes Diabetes Care 2016;39(Suppl. 1):S105–S106 References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S57 Finfer S, Chittock Dr, Su SY, et al for the NICE-SUGAR Study Investigators. Intensive versus conventional glucose control in critically ill patients. N Engl J Med. 2009;360:1283–1297 Griesdale DE, de Souza RJ, van Dam RM, et al. Intensive insulin therapy and mortality among critically ill patients: a meta-analysis including NICE-SUGAR study data. CMAJ 2009;180:821–827 222

Thank you

Trends in the Number and Proportion of Higher and Lower Level Recommendations
Trend from 2005 to 2014 in number and proportion of recommendations (Recs) made each year in the ADA Standards of Care that were based on higher-level evidence vs. lower-level evidence. Reference: Grant RW, Kirkman MS. Trends in the Evidence Level for the ADA Standards of Medical Care in Diabetes from 2004 – Diabetes Care Jan; Higher level recommendations defined as A or B evidence grades Lower level recommendations defined as C or E evidence grades Grant R W , and Kirkman M S Dia Care 2015;38:6-8 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S15; Table 1 226

Trends in the Proportion of Higher Level Recommendations by Category
Trends from 2005 to 2014 in annual proportion of recommendations based on higher- level evidence, stratified into four mutually exclusive categories: glycemic management and related issues (e.g., diabetes screening and diagnosis, microvascular complications); cardiovascular-related care (CVD) (e.g., blood pressure and lipid assessment and management); general recommendations related to lifestyle, nutrition, and self-management; and pediatric- or obstetric-related diabetes care. Reference: Grant RW, Kirkman MS. Trends in the Evidence Level for the ADA Standards of Medical Care in Diabetes from 2004 – Diabetes Care Jan; Grant R W , and Kirkman M S Dia Care 2015;38:6-8 Reference American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S15; Table 1 227

Antihyperglycemic Therapy in Type 2 Diabetes
This slide summarizes the general recommendations for antihyperglycemic therapy in type 2 diabetes, as outlined in the ADA-European Association for the Study of Diabetes (EASD) position statement Definitions: DPP-4-i,DPP-4 inhibitor; Fx’s, bone fractures; GI, gastrointestinal; GLP-1-RA, GLP-1 receptor agonist; HF, heart failure; SU, sulfonylurea; TZD, thiazolidinedione This 2015 position statement is less prescriptive than prior algorithms and discusses advantages/disadvantages of the available medication classes and considerations for use A patient-centered approach is stressed, including patient preferences, cost and potential side effects of each class, effects on body weight, and hypoglycemia risk Metformin is reaffirmed as the preferred initial agent, barring contraindication or intolerance, either in addition to lifestyle counseling and support for weight loss and exercise, or when lifestyle efforts alone have not achieved or maintained glycemic goals The progressive nature of type 2 diabetes and its therapies should be regularly and objectively explained to patients Equipping patients with an algorithm for self-titration of insulin doses based on SMBG results improves glycemic control in type 2 diabetic patients initiating insulin3 American Diabetes Association Standards of Medical Care in Diabetes. Approaches to Glycemic Treatment. Diabetes Care 2016; 39 (Suppl. 1): SX References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S25; Figure 2 Inzucchi SE, Bergenstal RM, Buse JB, et al., American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association of the Study of Diabetes (EASD). Diabetes Care 2012;35: Blonde L,MerilainenM, Karwe V, Raskin P; TITRATE Study Group. Patient-directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets the TITRATE study. Diabetes Obes Metab 2009;11:623–631 228

Approach To Starting & Adjusting Insulin in T2DM
Approach to starting and adjusting insulin in type 2 diabetes. FBG, fasting blood glucose; GLP-1-RA, GLP-1 receptor agonist; hypo, hypoglycemia; mod., moderate; PPG, postprandial glucose; #, number. Adapted with permission from Inzucchi et al. Diabetes Care, 2015;38: American Diabetes Association Standards of Medical Care in Diabetes. Approaches to Glycemic Treatment. Diabetes Care 2016; 39 (Suppl. 1): SX References American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care 2014;37(suppl 1):S27–S28 Blonde L,MerilainenM, Karwe V, Raskin P; TITRATE Study Group. Patient-directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets the TITRATE study. Diabetes Obes Metab 2009;11:623–631 Inzucchi SE, Bergenstal RM, Buse JB, et al. American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012;35:1364–1379 229

For patients of all ages with DM & ASCVD, add high-intensity statin therapy to lifestyle therapy. A For patients with DM aged <40 w/ add’l ASCVD risk factors, consider moderate- or high-intensity statin & lifestyle therapy. C For patients with DM aged 40–75 yrs without add’l ASCVD risk factors, consider moderate-intensity statin and lifestyle therapy. A For your patients of all ages with diabetes mellitus and ASCVD, add high-intensity statin therapy to lifestyle therapy. For patients with diabetes aged <40 w/ add’l ASCVD risk factors, consider using moderate- or high-intensity statin & lifestyle therapy. For patients with diabetes aged 40–75 years without add’l ASCVD risk factors, consider using moderate-intensity statin and lifestyle therapy. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular Disease and Risk Management. Diabetes Care 2016; 39 (Suppl. 1): SX 230

For patients with DM aged 40–75 yrs with add’l ASCVD risk factors, consider high- intensity statin & lifestyle therapy. B For patients with DM aged >75 yrs without add’l ASCVD risk factors, consider moderate-intensity statin therapy and lifestyle therapy. B For patients with diabetes aged >75 yrs with add’l ASCVD risk factors, consider moderate- or high-intensity statin therapy and lifestyle therapy. B For patients with diabetes aged 40–75 years with additional ASCVD risk factors, consider using high-intensity statin and lifestyle therapy. For patients with diabetes aged >75 years without additional ASCVD risk factors, consider using moderate-intensity statin therapy and lifestyle therapy. For patients with diabetes aged >75 years with additional ASCVD risk factors, consider using moderate- or high-intensity statin therapy and lifestyle therapy. [SLIDE] American Diabetes Association Standards of Medical Care in Diabetes. Cardiovascular Disease and Risk Management. Diabetes Care 2016; 39 (Suppl. 1): SX 231

Standards of Medical Care in Diabetes — 2016

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