1. A PNEA S CREENING FOR D IABETES P ATIENTS Sensible. Simple. Effective. Reaching out to more patients.

2. R EASONS TO I NTEGRATE AN A PNEA S CREENING P ROGRAM  Increasing Prevalence o 24%- Nearly one quarter of U.S. men suffer from some form of sleep disordered breathing (SDB).  International Diabetes Federation Recommendations OSA should be considered in the assessment of all patients with Type II Diabetes.  Improving Patient Care o Early detection & treatment reduces risk of disease & death related to other serious health conditions, such as: Type II Diabetes Hypertension Congestive Heart Failure Stroke New England Journal of Medicine. 1993; 328; 1230-1235. Shaw, et. al. Diabetes Research & Clinical Practice. 2008; 81: 2-12.

3. D IABETES & A PNEA Evidence indicates that the presence of one disease may trigger biological mechanisms that increase risk of the other. OSA Hypoxia & Sleep Fragmentation (Alters Glucose Metabolism) Stress Response (Alters Leptin Levels ; Increases Insulin Resistance) Glucose Intolerance/ Type II Diabetes Autonomic Neuropathy (Alters Ventilatory Control During Sleep) Shaw, et. al. Diabetes Research & Clinical Practice. 2008; 81: 2-12. Pagel, et. al. Supplement to The Journal of Family Practice. August 2008 ; Vol 57, No 8. D IABETES & A PNEA S CREENING S HOULD G O H AND IN H AND

4. Link Between Diabetes & SDB o 58% of Type II Diabetics have some form of sleep disordered breathing (SDB) Health Concerns o Both Diabetes & Apnea significantly increase risk of cardiovascular disease & death Treatment Concerns o Apnea negatively impacts glucose tolerance, insulin resistance & increased risk of metabolic syndrome  Leads to difficulties with diabetes management Richard; Gay & Farrell. The Economics of Sleep-Disordered Breathing. RT: June 2006. Shaw, et. al. Diabetes Research & Clinical Practice. 2008; 81: 2-12 S LEEP D ISORDERED B REATHING (SDB) IN THE D IABETIC P OPULATION

5. Improves Factors Related to Diabetes o Improves glycemic control o Improved insulin sensitivity and leptin levels o Reduces Sympathetic Activation o A key factor in regulation of glucose & fat metabolism, as well as systemic inflammation. – Biological mechanisms thought to contribute to insulin resistance. Reduces Cardiovascular Risk o Significantly decreases blood pressure (BP) o Improves Heart Function o Decreases # of new cardiovascular events & arrhythmias Improves Overall Patient Outcomes o Reduces morbidity & mortality associated with cardiovascular events & stroke o Patients using positive airway pressure have better Epworth Sleepiness Scale & Health-Related Quality of Life scores. Shaw, et. al. Diabetes Research & Clinical Practice. 2008; 81: 2-12 Richard; Gay & Farrell. The Economics of Sleep-Disordered Breathing. RT: June 2006. T REATING A PNEA

6. E CONOMIC I MPACT OF U NDIAGNOSED A PNEA  $3.4 billion Yearly estimate of the medical costs of untreated OSA in the U.S.  $15.9 billion Collision costs directly attributable to OSA in 2000.  $5 billion Yearly loss of productivity attributable to Apnea-related fatigue.  Other Indirect Costs E.g. higher insurance, production, & consumer costs Higher incidence of work-related accidents  Non-Financial Burden Increased incidence of disability Diminished quality of life for affected. Richard; Gay & Farrell. The Economics of Sleep-Disordered Breathing. RT: June 2006. Shaw, et. al. Diabetes Research & Clinical Practice. 2008; 81: 2-12 SDB P LACES S UBSTANTIAL E CONOMIC B URDEN ON THE U.S.

7. R EASONS FOR A PNEA S CREENING  SDB is Largely Undiagnosed Over 28 million Americans suffer from OSA, yet 20 million go undiagnosed & untreated.  Increased Health Risks SDB is associated with a range of comorbid conditions.  Significant Financial & Disability Burden Untreated SDB places substantial burden on both individuals & society. Logan, et. al. J Hypertens. 2001 Dec;19(12):2271-7. Jahaveri, et. al. Circulation. 1998;97:2154-2159 Basetti & Aldrich. Sleep. 1999 Mar 15;22(2):217-23. Finkel, et. al. Sleep Review July-Aug 2006. Shaw, et. al. Diabetes Research & Clinical Practice. 2008; 81: 2-12. SCREENING IDENTIFIES PATIENTS THAT WOULD NOT SEEK TREATMENT OTHERWISE.

8. P ROBLEMS WITH C OMMON S CREENING M ETHODS o Subjective o Not specific i.e. high # of false-positives - Leads to unnecessary testing & delayed Dx for those with severe apnea o Cannot indicate type/severity of SDB o Not Validated for Diabetic Population Questionnaires In-lab Polysomnography (PSG) o Costly o Impractical for Screening Population is too large o Can Take Days or Weeks to Receive Results o Higher refusal/drop-out rates Finkel, et. al.. Sleep Review July-Aug 2006. Magalang, et. al. Chest 2003; 124; 1694-1701. STOP Questionnaire; A Tool to Screen Patients for Obstructive Sleep Apnea. Chung, et. al.. Guidelines for the Perioperative Management of Patients with Obstructive Sleep Apnea. Anesthesiology 2006; 104:1081–93.

9. M ETA - ANALYSIS OF OSA Q UESTIONNAIRES Study Pooled Study n FN Rate Ease of Use, 0-3 Test Accuracy, by Diagnostic Odds Ratio (DOR)* Summary Recommendations ** Berlin Questionnaire 692.081-.03821Poor-Excellent May have role in screening for severe OSA, Unacceptable FN rate BMI alone4060.228 - 0.2980Poor Unacceptable FN rate Epworth Sleepiness Scale 460.7141Poor Unacceptable FN rate STOP Questionnaire 1770.205 - 0.3441Poor Unacceptable FN rate STOP-BANG1770.0 - 0.1642 Average- Excellent Excellent screening test for severe OSA, unacceptable FN rate for Dx of OSA *DOR combines data on sensitivity and specificity to give an indication of a test’s ability to rule in or rule out a condition. **Summary recommendations developed for preoperative use. S CREENING T EST R ELIABILITY & S UMMARY R ECOMMENDATIONS Many of the most commonly used screening questionnaires have poor predictive values, esp. for mild to moderate cases. Derived from Ramachandran, et. Al. Anesthesiology, V 110, No 4, Apr 2009

10. T HE S.O.S. A PPROACH  Subjective Screen o Use questionnaire (e.g. STOP-BANG; Berlin) to screen everyone The population at risk is often large and will often include many patients with low risk. A much smaller subgroup with very high risk will require expedient intervention.  Objective Screen o Oximetry (e.g. SatScreen) devices are widely used because of affordability, high predictive value, & minimal patient impact. Identifies the high risk subgroup. “S.O.S.” Subjective Objective Screening Research shows a combination approach can be the most feasible & effective method Hwang, et. al. Chest 2008; 133; 1128-1134.

11. Patents High resolution oximetry with digital pattern analysis & recognition SatScreen  Oximetry screening o FDA cleared acquisition, analysis & reporting software Patient Safety Connection Center  Oximetry & HST software management platform P ATIENT S AFETY, I NC T ECHNOLOGY B REAKTHROUGHS

12. W HY S AT S CREEN ? Most oximetry software only report raw data, ODI & O2 ranges. Accurate & Cost-Effective Results in Minutes Easy to Read Green to red indices for important information Indicates Arousal Failure & Hypoventilation Syndromes Indicative of more serious SDB & may require a different treatment approach Highlights Frequency of Events & Severity of O 2 Desaturations Bloch. Chest 2003; 124; 1628-1630. ASA Task Force. Anesthesiology 2006; 104:1081–93. Madani. Advance for Respiratory Care and Sleep Medicine. Posted on January 7, 2009.

13. G ET S TARTED Define your protocol for at risk patients Determine your Screening Protocol Gather your team & assign responsibilities Practice Guidelines If patient is identified as at risk, follow ASA guidelines or preferred protocol Develop discharge instructions / plan Questions? We want to help you make your organization’s OSA screening program a success. Please contact us at: 1-888-666-0635 support@patientsafetyinc.com