© 2013 Eli Lilly and Company The Optimisation and Intensification of Insulin Therapy in Type 2 Diabetes Speaker name and affiliation Prescribing information is available on the last slide.UKDBT01538 September 2013

Assessment of poor glycaemic control

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company Troubleshooting failure of initiated insulin regimen 3 What is the problem?  Original goals of therapy not being met  HbA1c / Blood glucose profiles  Weight ( usually gain)  Persistent hyperglycaemia  Problematic hypoglycaemia  Compliance – poorly compliant or non-compliant Patient Medical Factors  Co-morbidity (CVD / Renal / Neurological/ Other)  Pre-conception/ pregnancy Patient Social Factors  Preferences / barriers  Devices  Eating habits / Activity levels  Employment

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company Assessing reasons for sub optimal blood glucose control 4  Changing treatment alone may not improve control  The most important aspect is identifying the reason for poor control first  Assessment should take into account all factors that may influence glycaemic control

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company 5 Factors that may influence glycaemic control Concurrent illnesses Worsening of co-morbidities Stress Concomitant medications Significant diet changes Physical activities Compliance Injection technique Weight changes

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company Optimising glycaemic control 6 Optimising  Blood glucose profiles, fasting and post prandial levels  HbA1c  Risk of hypoglycaemia  Long term clinical outcomes  Quality of life How ?  Reviewing diet and lifestyle measures first  Review Blood Glucose Monitoring  Ensuring appropriate titration  Reviewing concomitant oral medications and subsequent compliance  Engaging patients in the decisions

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company Glycaemia - rules of thumb 7

Assessment of diet and lifestyle

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company Dietary assessment/considerations 9  Timing and frequency of meals  Snacks  Amount eaten  Appetite  Weight change or  Carbohydrate intake  Work and lifestyle patterns  Any missed meals  Variety of food eaten  Cultural influences  Alcohol  Treats......

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company Lifestyle assessment 10 Exercise/ activity  Any changes in exercise/activity  Planned/unplanned eg any routine  Frequency, duration  How do they prepare for exercise/activity (extra carb or reduction in medications)

Concordance and diabetes

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company Concordance in diabetes 12 Objective data on concordance in diabetes: Studies have found:  Only 31% on sulphonylurea monotherapy have ‘adequate’ concordance 1  Only 34% on metformin monotherapy have ‘adequate’ concordance 1  There is significantly poorer adherence with each increase in the daily number of tablets taken 1  28% do not collect enough insulin to meet prescription 2  Insulin adherence among patients with type 2 diabetes was 62-64% 3  21% with type 2 diabetes collect no test strips 4 1.Donnan,PT et al Diabet Med. 2002, 19: Morris AD, et al Lancet (9090): Cramer JA Diabetes Care : Evans JM et al BMJ : 83-86

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company Assessment of concordance in diabetes 13  Check prescription collection….. Even if all collected doesn’t necessarily mean they take it  Ask the right questions….  Do you take all of your tablets/insulin ?? - likely response ?  Consider  How often do you miss your tablets/insulin ??  What would stop you taking your tablets /insulin??

Assessment of Glycaemic control

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company What’s the HbA1c here? 15 Target Glucose Range Breakfast Lunch Dinner Blood glucose (mmol/l)

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company Blood Glucose Monitoring 16  Do trends in self-monitored blood glucose reflect HbA1c? e.g. apparently ‘normal’ home blood glucose results but abnormally high HbA1c  Technique – washed hands, clean dry surface to perform test, good light and glasses if appropriate. Does patient know how to use the machine?  Is the machine in good working order and calibrated as appropriate – is the machine calibrated as per manufacturers instructions? Is the patient aware that they can phone the meter manufacturers for advice and obtain control solution, batteries, and a new meter if required?  Are test strips stored correctly and in date?  Blood glucose monitoring appropriate for insulin regimen – are they testing at appropriate times and pertinent frequency?

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company Blood Glucose Monitoring: hyperglycaemia 17  What blood glucose level do they consider to be too high  Any symptoms of hyperglycaemia?  At what blood glucose level do they experience symptoms?  Is there any pattern to blood glucose results?  How do they manage hyperglycaemia?  Do they adjust diet or medications based on blood glucose results?

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company Structured blood glucose monitoring 18 Structured blood glucose monitoring is essential to identify “problem areas” this assessment must also include... 1  Hypoglycaemia Frequency / time of day / circumstances (pre v post meal)  Fasting Hyperglycaemia Frequency ± pre-meal hyperglycaemia  Post-prandial Hyperglycaemia Frequency, degree, which meal 1.NICE Clinical guideline ;n/a: 1-20

Combining structured blood glucose and dietary assessment

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company Discovery sheets 20  Used for up to 7 days to facilitate a structured blood glucose monitoring approach  Patients are asked to record pre and post prandial blood glucose results, alongside food eaten  Helps determine pre prandial blood glucose control & post prandial response to carbohydrate intake  Engages and facilitates patients making the connection between blood glucose monitoring results and food eaten  Engages patients in identifying possible solutions.

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company Discovery sheets 21

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company Teaching patients to eat under the curve 22 Blood glucose level pre meal 6.1 mmol/l Blood glucose level post meal 8.6 mmol/l

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company Teaching patients to eat under the curve 23 Blood glucose level pre meal 6.1 mmol/l Blood glucose level post meal 16.1 mmol/l….. Consider options ?

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company Teaching patients to eat under the curve 24

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company Blood Glucose Monitoring: hypoglycaemia 25  What do you understand by the term hypoglycaemia  What symptoms of hypoglycaemia do you get /or how would you recognise you were hypo?  At what blood glucose level do you know you are hypo?  Who recognises hypos first themselves or others?  Are they always able to treat hypos themselves, have they ever needed help to treat a hypo  Can they always identify why they've had a hypo  Checks diary ( ask if they always record hypos)  Checks meter  How do they treat hypos and how long it takes to recover If you suspect hypos also worth asking... Any morning headaches ? Sleep pattern to see if disturbed ? Any unexplained profuse sweating?

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company Remember 26 Hypoglycaemia is....  A common side effect of insulin treatments, predominantly insulin, also sulphonylureas, post prandial regulators  Usually the main factor preventing good metabolic control  Impactful on the individuals quality of life Managing hypoglycaemia should include  A thorough assessment to ensure hypoglycaemia is not undetected by the individual and/or HCP,  Education to ensure recognition of symptoms, appropriate treatment and prevention strategies  Teaching patients effectively to self manage their diabetes to reduce the risk of severe episodes

Injection assessment

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company Insulin Administration 28  Injection sites - check for signs of lipohypertrophy (subcutaneous fatty lump) bruising, rotation of sites, where are they injecting?  Injection technique – needle administered at the correct angle, fully inserted and held in-situ after administration of insulin for a slow count of 5 before removal of needle (does the patient see insulin on the skin post injection?)  Device - is the insulin administration device (e.g. pen) being used correctly AND has the person who is administrating the insulin been trained correctly e.g. carer  Mixing - if appropriate is the insulin being mixed correctly?  Timing of injections – in relationship to meals and consistency of injections, do they miss their dosages, how often and if so why?  Dose adjustment – do they adjust insulin doses, if so in what circumstances and how do they do this ? Forum for Injection Technique (FIT) 2011; 2: 1-24

Co morbidities and the impact on glycaemic control

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company Co morbidities and the impact on glycaemic control 30 Declining renal function  May influence accuracy of HbA1 C  Influences insulin clearance  Influences use of some oral medications  Increased risk of hypoglycaemia Yadav S C B Clinical Queries: Nephrology 2012; 1: Depression  Often associated with decreased self management skills  Reduction of exercise  “ Comfort eating”  Reduces concordance with medications  Stress increases adrenaline and cortisol response Lin et al: Relationship of depression and diabetes self-care, medication adherence, and preventive care. Diabetes Care. 2004;

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company Co morbidities and intercurrent illness and the impact on glycaemic control 31 Development of other medical condition  Consider if this will impact on glycaemic control, eg cardiovascular disease/ angina and reduced exercise capacity Intercurrent illness  Typically Increases blood glucose levels.  Poorly controlled diabetes increases the risk of infections Avery & Beckwith Oxford Handbook of Diabetes Nursing 2009; N/A:  Any pharmacological interventions commenced that would influence control eg corticosteroids Williams Handbook of Diabetes 2004; 3: 232  Assess whether this short term or long term.

Company Confidential © 2012 Eli Lilly and Company © 2013 Eli Lilly and Company Conclusion 32  Changing treatment alone may not improve control  The most important aspect is identifying the reason for poor control first  Assessment should take into account all factors that may influence glycaemic control

UKDBT01538 September 2013