1. Diabetes Mellitus A Unique Opportunity to Integrate Specialty and Primary Care to Attain Therapeutic Goals with Cost Reduction

2. FAHC – 9 medical Home Sites – All on same EMR – One group of Endocrinologists – Using same registries and templates

3. Roadmap What – outcomes Who – Demographic – How we’re doing How – Clinical pathway – CDEs – CHTs – Integrated Specialty and Primary care roadmaps Why – Delivery of quality, best practice care – Imprinting – Cost saving

5. What These may include decreased ER visits, decreased hospitalizations, attainment of targets

6. Who Diabetes affects 25.8 million people of all ages 8.3 % of the U.S. population DIAGNOSED 18.8 million people UNDIAGNOSED 7.0 million people Vermont about 6.9% of population of about 625,000

7. Demographics Among U.S. residents ages 65 years and older, 10.9 million, or 26.9 percent, had diabetes in 2010. About 215,000 people younger than 20 years had diabetes— type 1 or type 2—in the United States in 2010. About 1.9 million people ages 20 years or older were newly diagnosed with diabetes in 2010 in the United States. In 2005–2008, based on fasting glucose or hemoglobin A1C (A1C) levels, 35 percent of U.S. adults ages 20 years or older had pre-diabetes—50 percent of adults ages 65 years or older. Applying this percentage to the entire U.S. population in 2010 yields an estimated 79 million American adults ages 20 years or older with pre-diabetes. Diabetes is the leading cause of kidney failure, nontraumatic lower-limb amputations, and new cases of blindness among adults in the United States. Diabetes is a major cause of heart disease and stroke. Diabetes is the seventh leading cause of death in the United States.

8. Demographics Chronic Diseases are the Leading Causes of Death and Disability in the U.S. 7 out of 10 deaths among Americans each year are from chronic diseases. Heart disease, cancer and stroke account for more than 50% of all deaths each year. 1 1 In 2005, 133 million Americans – almost 1 out of every 2 adults – had at least one chronic illness. 2 2 Obesity has become a major health concern. 1 in every 3 adults is obese 3 and almost 1 in 5 youth between the ages of 6 and 19 is obese (BMI ≥ 95th percentile of the CDC growth chart). 4 3 4 About one-fourth of people with chronic conditions have one or more daily activity limitations. 5 5 Arthritis is the most common cause of disability, with nearly 19 million Americans reporting activity limitations. 6 6 Diabetes continues to be the leading cause of kidney failure, nontraumatic lower-extremity amputations, and blindness among adults, aged 20-74. 7 7

9. Chronic Diseases are the Leading Causes of Death and Disability in the U.S. 7 out of 10 deaths among Americans each year are from chronic diseases. Heart disease, cancer and stroke account for more than 50% of all deaths each year. 1 1 Heart disease and stroke much more prevelent in patients with diabetes Obesity has become a major health concern. 1 in every 3 adults is obese 3 and almost 1 in 5 youth between the ages of 6 and 19 is obese (BMI ≥ 95th percentile of the CDC growth chart). 4 3 4 Diabetes continues to be the leading cause of kidney failure, nontraumatic lower-extremity amputations, and blindness among adults, aged 20-74. 7 7

10. Percentages of Adults With Recommended Levels of Vascular Disease Risk Factors in NHANES 1999-2008 How are we doing ? Not great !

11. HOW

12. CDE A Certified Diabetes Educator® (CDE®) is a medical/health care professional who possesses comprehensive knowledge of and experience in diabetes management, pre-diabetes, and diabetes prevention. A CDE® educates and supports people affected by diabetes to understand and manage the condition. A CDE® promotes self-management to achieve individualized behavioral and treatment goals that optimize health outcomes. The Certification Examination for Diabetes Educators is designed and intended solely for health care professionals who have job responsibilities that include the direct provision of diabetes self- management education (DSME), as defined by NCBDE. It is not for those who may perform some diabetes related functions as part of or in the course of other usual and customary occupational duties

13. CDE Assesses Individual Patient’s Educational Needs & Readiness To Learn 1. Relevant medical history 2. Current health status or level of self care 3. Psychological status/Motivation 4. Health service or resource utilization 5. Cultural/Religious influences 6. Health beliefs and attitudes

14. Assessment (cont.) 8. Support systems 9. Previous education/actual knowledge/perceived learning needs/goals 10. Barriers to learning/self care Physical – mobility/dexterity/vision/hearing/pain Cognitive - literacy/problem solving Behavioral – Stress & coping, self efficacy, motivation, health belief model

15. 7 self-care behaviors healthy eating being active monitoring taking medication problem solving reducing risks healthy coping

16. Barriers To Follow-up Motivation Driving conditions Competing health needs/problems Finances/insurance doesn’t cover Scheduling access problems Referred to another program

17. HOW Dr Gilwee defined the CHT role Literature is mixed We may have opportunity to show outcomes improvement with a defined population

18. A diabetes management mentor program: outcomes of a clinical nurse specialist initiative to empower staff nurses. Clin Nurse Spec. 2012 Sep;26(5):263-71 Clin Nurse Spec. The clinical nurse specialist is expertly prepared to foster the professional development of bedside nurses while simultaneously making a positive impact on disease management

19. Postgrad Med. 2012 Mar;124(2):64-76. Postgrad Med. Managing diabetes with integrated teams: maximizing your efforts with limited time. During the past 5 years, the number of treatment options and the complexity of treatment guidelines for diabetes have increased markedly, which makes treatment decisions more complicated and time-consuming, and greatly impacts the workload of the primary care physicians who deliver care to the majority of this population. To provide optimal diabetes care when time and resources are limited, primary care physicians may want to enlist the support of other providers,

20. Results On average, the number of outpatient visits decreased from 8.38 in the year before participants began the program to 7.70 (p=0.04) in the year after they finished the program. In addition, the unadjusted mean number of inpatient admissions per year was significantly reduced from 0.34 to 0.20(p=0.02). Clin Med Res. 2012 Aug;10(3):159. Clin Med Res. PS1-35: Impact of an ADA-Accredited Diabetes Education on Healthcare Utilization. Minneapolis

21. A word about Hb A1c Glycemic goals in adults ● Lowering A1C to below or around 7% has been shown to reduce microvascular and neuropathic complications of type 1 and type 2 diabetes. Therefore, for microvascular disease prevention, the A1C goal for nonpregnant adults in general is 7%. (A)

22. In type 1 and type 2 diabetes, randomized controlled trials of intensive versus standard glycemic control have not shown a significant reduction in CVD outcomes during the randomized portion of the trials. Long-term follow-up of the DCCT and UK Prospective Diabetes Study (UKPDS) cohorts suggests that treatment to A1C targets below or around 7% in the years soon after the diagnosis of diabetes is associated with long- term reduction in risk of macrovascular disease. Until more evidence becomes available, the general goal of 7% appears reasonable for many adults for macrovascular risk reduction. (B)

23. Subgroup analyses of clinical trials such as the DCCT and UKPDS and evidence for reduced proteinuria in the ADVANCE trial suggest a small but incremental benefit in microvascular outcomes with A1C values closer to normal. Therefore, for selected individual patients, providers might reasonably suggest even lower A1C goals than the general goal of 7%, if this can be achieved without significant hypoglycemia or other adverse effects of treatment. Such patients might include those with short duration of diabetes, long life expectancy, and no significant CVD. (B)

24. Conversely, less stringent A1C goals than the general goal of 7% may beappropriate for patients with a history of severe hypoglycemia, limited life expectancy, advanced microvascular or macrovascular complications, or extensive comorbid conditions and those with longstanding 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.

25. ADA/ACC/AHA Position Statement No change in glycemic control targets - nonpregnant adults <7%. For selected individuals might reasonably suggest even lower if this can be achieved without significant hypoglycemia: –Short duration of diabetes. –Long life expectancy. –No significant CVD. Less stringent goal for patients with: –History of severe hypoglycemia. –Limited life expectancy. –Advanced micro- or macrovascular complications, extensive comorbid conditions. –Longstanding diabetes in whom the general goal is difficult to attain despite diabetes self-management etc. ADA. Diabetes Care 2009;32:187

26. Standard of Care Approach is Multifactorial Individualized Therapy Current treatment practices entail multifactorial therapy - attain predefined targets for blood glucose control, blood pressure, and lipids. In the future those “predefined” targets will be individualized.

28. AACE/ACE Diabetes Algorithm A1C 6.5-7.5% Insulin ± Other agents MET DPP4 GLP-1 TZD AGI A1C 7.6-9.0%A1C > 9.0% MET TZD MET GLP-1, DPP4 or TZD SUorGlinide + + + + + GLP-1, DPP4 TZD SUorGlinide colesevelam AGI TZD GLP-1 Or DPP4 GLP-1 Or DPP4 MET +TZD +SU TZD + + MET Insulin ± Other agents MET+ GLP-1or DPP4 GLP-1or DPP4 GLP-1or DPP4 TZD ± SU ± TZD Lifestyle Modification Monotherapy Dual Therapy Monotherapy Triple Therapy Dual Therapy Drug NaiveUnder Treatment Glycemic Control Algorithm, Endocr Pract. 2009;15(No. 6) 541 www.AACE.com/pub Each step 8-12 weeks

29. Primary care visits > 2 visits per year Hb A1c 1-4 tests per year Fasting blood sugar 4-6 test per tear Urine protein yearly Documented foot exam at every regular visit Documented retinal exam at least yearly Total cholesterol at least yearly Hb A1c 7.0% Smoking cessation LDL cholesterol < 100 mg/dl HDL cholesterol >40 or 50 mg/dl Triglycerides <150 mg/dl Blood pressure < 130/80 mm Hg Influneza vaccine Pneumococcal vaccine RD DSMT HGSM Diabetes Care Metrics

30. Intensive Diabetes Treatment and Cardiovascular Disease in Patients With Type 1 Diabetes Background – Studied whether use of intensive therapy as compared with conventional therapy during the DCCT affected the long-term incidence of cardiovascular disease DCCT/EDIC Study Research Group, N Engl J Med 2005; 353:2643-53.

31. Intensive Diabetes Treatment and Cardiovascular Disease in Patients With Type 1 Diabetes Results – During the mean 17 years of follow-up, 46 cardiovascular disease events occurred in 31 patients who had received intensive treatment in the DCCT, as compared with 98 events in 52 patients who had received conventional treatment DCCT/EDIC Study Research Group, N Engl J Med 2005; 353:2643-53.

32. Intensive Diabetes Treatment and Cardiovascular Disease in Patients With Type 1 Diabetes Results – Intensive treatment reduced the risk of any cardiovascular disease event by 42% (p=0.02) and the risk of nonfatal MI, stroke, or death from cardiovascular disease by 57% (p=0.02) DCCT/EDIC Study Research Group, N Engl J Med 2005; 353:2643-53.

33. Intensive Diabetes Treatment and Cardiovascular Disease in Patients With Type 1 Diabetes Results – Decrease in glycosylated hemoglobin values during the DCCT was significantly associated with most of the positive effects of intensive treatment on the risk of cardiovascular disease DCCT/EDIC Study Research Group, N Engl J Med 2005; 353:2643-53.

34. Intensive Diabetes Treatment and Cardiovascular Disease in Patients With Type 1 Diabetes Results – Microalbuminuria and albuminuria were associated with a significant increase in the risk of cardiovascular disease, but differences between treatment groups remained significant (P≤0.05) after adjusting for these factors DCCT/EDIC Study Research Group, N Engl J Med 2005; 353:2643-53.

35. Intensive Diabetes Treatment and Cardiovascular Disease in Patients With Type 1 Diabetes Conclusions – Intensive diabetes therapy has long-term beneficial effects on the risk of cardiovascular disease in patients with type 1 diabetes DCCT/EDIC Study Research Group, N Engl J Med 2005; 353:2643-53.

36. Cumulative Incidence of the First of Any of the Predefined Cardiovascular Disease Outcomes Years since entry Cumulative incidence of any predefined cardiovascular outcome Conventional treatment Intensive treatment DCCT/EDIC Study Research Group, N Engl J Med 2005; 353:2643-53. Intensive705683629113 Conventional71468861892 No. at Risk

37. Cumulative Incidence of the First Occurrence of Nonfatal MI, Stroke, or Death from Cardiovascular Disease Years since entry Cumulative incidence of nonfatal MI, stroke, or death from cardio. disease Conventional treatment Intensive treatment DCCT/EDIC Study Research Group, N Engl J Med 2005; 353:2643-53. Intensive705686640118 Conventional72169463796 No. at Risk

38. Diabetes-related deaths 38 UKPDS Epidemiological Data HbA 1c and Risk of Complications in T2 DM Stratton IM, et al. BMJ 2000;321:405–412 HbA 1c Any diabetes-related endpoint 14% decrease per 1% reduction in HbA 1c p < 0.0001 0.5 1 10 056789 11 Hazard ratio HbA 1c Fatal and nonfatal MI HbA 1c 0.5 1 5 0567891011 21% decrease per 1% reduction in HbA 1c p < 0.0001 0.5 1 10 056789 11 37% decrease per 1% reduction in HbA 1c p < 0.0001 HbA 1c Hazard ratio Microvascular endpoints Hazard ratio ADA Goal 0567891011 21% decrease per 1% reduction in HbA 1c p < 0.0001 0.5 1 5 Hazard ratio 20 yr followup

39. After median 8.5 years post-trial follow-up in UKPDS Aggregate endpoint 1997*2007 Any diabetes related endpointRRR:12%9% p: 0.029 0.040 Microvascular diseaseRRR: 25%24% p: 0.00990.001 Myocardial infarctionRRR:16%15% p: 0.0520.014 All-cause mortalityRRR:6%13% p: 0.440.007 RRR = Relative Risk Reduction, p = Log rank Memory of Early Intensive Blood Glucose Intervention on CVD in Type 2 DM *End of randomized intervention Holmann RR et al. NEJM 359: 1577-1589, 2008

40. 10-year Follow-up of UKPDS Holmann RR et al. NEJM 359: 1577-1589, 2008

41. 160 patients with type 2 DM and microalbuminuria cared for by primary care providers randomized to conventional or intensive, multifactorial care. Gæde P et al. N Engl J Med 2003;348:383. Steno 2 Trial: Multifactorial Intervention

42. STENO 2

43. Continued Prevention of CVD After Stopping Trial of Multifactorial Therapy: Steno 2 Trial Gæde P et al. N Engl J Med 2005;358:580-591.

44. Conclusion Early - from diagnosis - intensive blood glucose and multifactorial therapy are PROVEN to instill LONG-TERM cardiovascular and microvascular protection in type 2 DM.