1. Building a Diabetes Alliance: The Role of Provider Education Robert E. Jones, MD, FACP, FACE Professor of Medicine University of Utah School of Medicine and Friend of the UDPCP

2. The Problem

3. US Population: 275 million in 2000 Undiagnosed diabetes 5.9 million Diagnosed type 1 diabetes ~1.0 million Additional 16 million with prediabetes Diagnosed type 2 diabetes 10 million Distribution of Glycemic Abnormalities in US CDC. Available at: http://www.cdc.gov/diabetes/pubs/estimates.htmhttp://www.cdc.gov/diabetes/pubs/estimates.htm ADA. Facts and Figures. Available at: www.diabetes.org/main/application/commercewf?origin=*.jsp&event=link(B1)

4. Diabetes Complications Retinopathy: -Type 1: 60% at 10 years and ~100% at 20 years -Type 2: 20% at diagnosis and 60-80% at 20 years Neuropathy: -Types 1 and 2: >50% lifetime risk (approaches 100% with nerve conduction studies) Nephropathy: -Type 1: 40-50% at 20 years -Type 2: 5-10% at 20 years Coronary Artery Disease: -3 to 6 fold increased risk compared to non-diabetics -Major cause of death in all people with diabetes -10 to 20 year reduction in life expectancy Peripheral Vascular Disease: -Lifetime risk of amputation is 8/1000

5. Building a Coalition Diabetes and it’s complications are expensive and both the suffering and expense might be avoidable Stakeholders must be identified and all should benefit from participation –Patients, providers, insurers and government agencies There is a common mistrust between all

6. Diabetes Alliance Must involve a commitment of all those affected by diabetes: –Patients –Providers –Insurers –Government agencies Do any of these groups benefit from a bad outcome? –In the short term, they all do –In the long term, they all suffer

7. The Importance of Early, Aggressive Glucose Control

8. Years A1C (%) Intensive Group Conventional Group DCCT: Change in A 1C Over Time DCCT. N Engl J Med. 1993;329:977

9. DCCT: Diabetic Complication Event Rates 55.0 29.8 23.9 5.1 13.4 13.0 7.9 16.4 5.0 2.5 0 10 20 30 40 50 60 Retinopathy Progression 1 Laser Rx 1 Micro- albuminuria 2 Albuminuria 2 Clinical Neuropathy 3 Conventional Intensive 76% Risk Reduction 59% 39% 54% 64% Cumulative Incidence (%) 1. DCCT Research Group. Ophthalmology. 1995;102:647; 2. DCCT Research Group. Kidney Int. 1995;47:1703; 3. DCCT Research Group. Ann Intern Med. 1995;122:561

10. DCCT: Lifetime Benefits of Intensive Therapy 5.1 15.3 05101520 Years DCCT. JAMA. 1996;276:1409 Gain in Complications- Free Living* Gain in Length of Life *Significant microvascular or neurologic complication

11. EDIC Year A1C (%) Intensive Therapy Conventional Therapy DCCT: Average A 1C 4 Years After Trial DCCT/EDIC Research Group. N Engl J Med. 2000;342:381

12. DCCT: Progression of Retinopathy 4 Years After Trial Conventional Therapy Intensive Therapy Cumulative Incidence (%) EDIC Year Reprinted with permission from DCCT/EDIC Research Group. N Engl J Med. 2000;342:381

13. EDIC Reduction in CV Disease Events were reduced 57% (12-79% [95% CI]; P=0.02) NEJM 2005;353:2643-2654 DCCTEDIC

14. UK Prospective Diabetes Study Group: A 1C Reprinted with permission from UKPDS. Lancet. 1998;352:837-853. 6 7 8 9 012345678910 Years A1C (%) Intensive Group Conventional Group Subjects with A 1C <7%: 3 years 45% 6 years 30% 9 years 15%

15. Complications DCCT 1,2 Kumamoto 3 UKPDS 4 9% 7% 9% 7% 8% 7% Retinopathy63%69%17%–21% Nephropathy54%70%24%–33% Neuropathy60%–– Macrovascular disease 41%*–16%* Control: Reduction In Complications *Not statistically significant 1 DCCT Research Group. N Engl J Med. 1993;329:977; 2 DCCT Research Group. Diabetes. 1995;44:968; 3 Ohkubo Y et al. Diabetes Res Clin Pract. 1995;28:103; 4 UKPDS Group. Lancet. 1998;352:837

16. UKPDS 10 Year Poststudy Followup Following completion of UKPDS, therapy was left to the discretion of providers The difference in A1C disappeared (like EDIC) Results: –Microvascular Disease (RR=0.76; p=0.001) –Diabetes Endpoint (RR=0.91; p=0.04) –Death from Diabetes (RR=0.83;p=0.01) –All Cause Mortality (RR=0.87;p=0.007) –Myocardial Infarction (RR=0.85;p=0.01) Holman RR et al. NEJM 2008;359:1577-1589

17. Pre-Study Glyemic Exposure and Microvasular Outcomes 10 20 30 40 7.1 57.6108.1 Glycemic Exposure* Complication Risk Reduction (%) ADVANCE *Glycemic Exposure=Duration of Diabetes x Study Entry A1C Neuropathy Nephropathy Retinopathy Jones RE, Wadweker D. In press, 2010. UKPDS VADT ** Statistically Significant **

18. Utah Diabetes Prevention and Control Program: Provider Education

19. First Attempt (~1995) Over 50 providers licensed in Utah were given the primary literature (DCCT and UKPDS plus derivative articles) and asked to establish treatment goals for glucose, lipids and blood pressure in people with diabetes

20. First Attempt (~1995) 7.2---It’s Up to You! BP 140/90 mm Hg LDLc 130 mg/dl

21. Introduction 1997 was a unique year: –DCCT was “4 years old” and UKPDS was “2 years old” –The ADA had just defined goals for diabetes management –Insulin lispro, metformin and troglitazone were recently approved by the FDA –The Expert Committee redefined the diagnostic criteria for diabetes (FBS 126 vs 140 mg/dl) – Utah Diabetes Control Program initiated a process for certification of Diabetes Self Management Programs

22. The Perfect Storm

23. Phase 1 (1999-2002) Defining Diabetes, Targets and Complications CME events were by invitation of the local certified diabetes educators in order to highlight their skills Topics centered on the diagnosis of diabetes, setting targets, the management of diabetes and diabetes complications plus treatment of HTN and lipids Attendees were given copies of the Utah Diabetes Management Handbook (1999)

24. Topics Diagnosis and natural history of diabetes (types 1 and 2) Management of type 1 diabetes Management of type 2 diabetes Insulin resistance Cardiovascular complications of diabetes Microvascular complications of diabetes and management Acute complications of diabetes Designing insulin regimens Insulin pumps

25. Phase 2 (2003-2006) The Utah Diabetes Practice Recommendations Again, CME events were by invitation of the local providers or the diabetes educators Topics centered on the management of diabetes in a variety of settings (outpatient, inpatient and pregnacy) Providers were given a “Chinese Menu” for topics Attendees were given copies of the Utah Diabetes Management Handbook (2003) and applicable UDPRs

26. Topics Utah Diabetes Practice Recommendations –Management of diabetes in adults –Glycemic management (types 1 and 2) –Management of HTN and lipids –Establishing and achieving targets for BP, lipids, feet and eyes –Hyperglycemia in pregnancy –Hyperglycemia in hospitalized patients –Diabetes in children and adolescents http://health.utah.gov/diabetes/diabetespracticerecommend ations/udpr.htmhttp://health.utah.gov/diabetes/diabetespracticerecommend ations/udpr.htm Prior topics were also available

27. ADA/EASD Consensus Statement (2008) Tier 1: Well-validated core therapies Tier 2: Less well-validated therapies Adapted from Nathan DM et al. Diabetes Care. 2008:31;1-11. Reinforce lifestyle interventions at every visit and check A1C every 3 months until A1C is <7% and then at least every 6 months. Step 1 Step 2 Step 3 At diagnosis: Lifestyle + Metformin Lifestyle + Metformin + Basal Insulin Lifestyle + Metformin + Sulfonylurea Lifestyle + Metformin + Intensive Insulin Lifestyle + Metformin + Pioglitazone Lifestyle + Metformin + GLP-1 agonist Lifestyle + Metformin + Pioglitazone + Sulfonylurea Lifestyle + Metformin + Basal Insulin Step 2

28. ADA/EASD Consensus Statement (2008) Tier 1: Well-validated core therapies Tier 2: Less well-validated therapies Adapted from Nathan DM et al. Diabetes Care. 2008:31;1-11. Reinforce lifestyle interventions at every visit and check A1C every 3 months until A1C is <7% and then at least every 6 months. Step 1 Step 2 Step 3 At diagnosis: Lifestyle + Metformin Lifestyle + Metformin + Basal Insulin Lifestyle + Metformin + Sulfonylurea Lifestyle + Metformin + Intensive Insulin Lifestyle + Metformin + Pioglitazone Lifestyle + Metformin + GLP-1 agonist Lifestyle + Metformin + Pioglitazone + Sulfonylurea Lifestyle + Metformin + Basal Insulin Step 2

29. The failure of clinicians and their patients with diabetes to implement currently available interventions aggressively and effectively is…the major barrier to good care. This problem will not be fixed by making more medications available. Current Therapies Nathan D. NEJM 2007;356:437-440.

30. UDPRs Glycemic Algorithm UDPRs, 2009 Possible weight increase, Greater A1C lowering (>1%), Principally reduce FPG Basal insulin (most effective) Sulfonylureas (least expensive) TZDs (no hypoglycemia) Incretomimetics (most weight loss) DPP-IV inhibitors (least effective) Possible weight loss (or neutral), Lesser A1C lowering (<1%), Principally reduce PPG Not included: Amylomimetics; Meglitinides; AGIs Diagnosis; initiate lifestyle modifications (education) and start metformin -Patient’s Goals -Fasting v Postprandial Target (A1C) -Weight Effects -Cost -Relative Efficacy -Age -Cardiac, Renal and Hepatic Function Individually Assess Patient

31. Hypertension Algorithm UDPRs, 2009

32. Measurables UDPRs –38,500 downloads –Interest and inquiries throughout the country Provider education –Independent reviews, insurers and patient surveys The frequency of target measurement/documentation (lipids, BP, microalbumin, A1C, foot exam) has significantly increased Meeting established targets cannot be ascertained or has not changed

33. Are We Having an Impact?

34. Current State of Diabetes Management Targets –A1C < 7% –BP < 130/80 mm Hg –Total cholesterol < 200 mg/dL or LDL < 100 mg/dL 1 Saydah et al. JAMA 2004;291:335-342 2 BARI 2D Study Group. NEJM 2009;360:2503-25-2515. StudyA1CBlood Pressure CholesterolAll 3 Met NHANES 1 37%35.8%51.8%7.3% BARI 2D 2 33%