1. D iabetes I n C anada Evaluation (The DICE Study): Impact on Family Practice Stewart B. Harris MD MPH FCFP FACPM Associate Professor Centre for Studies in Family Medicine Ian McWhinney Chair of Family Medicine Studies Schulich School of Medicine and Dentistry University of Western Ontario London, Ontario

2. Overview What is diabetes? Epidemiology of diabetes Revisiting the CDA guidelines How are FPs doing? Review of the DICE study findings

3. What Is Diabetes? Type 1 diabetes (5-10%) Body’s own immune system attacks the cells in the pancreas that produce insulin Type 2 diabetes (90 - 95%) The pancreas does not produce enough insulin and/or the bodies’ tissues do not respond properly to the actions of insulin Caused by both genetic and environmental factors Gestational diabetes Diabetes with first onset or recognition during pregnancy Puts women at higher risk for type 2 DM later in life

4. What Diabetes is NOT Diabetes is NOT “a touch of sugar” It is a serious chronic disease that can lead to complications such as heart attack, stroke, blindness, amputation, kidney disease, sexual dysfunction, and nerve damage

5. The Complications of Diabetes

6. Macrovascular Microvascular Stroke Heart disease and hypertension Ulcers and amputation Diabetic eye disease (retinopathy and cataracts) Renal disease (Kidney) Neuropathy Foot problems Peripheral vascular disease Diabetes Complications

7. Diabetes = CVD Up to 80% of adults with diabetes will die of cardiovascular disease. Adapted from Barrett-Connor 2001.

8. Cardiovascular Disease Diabetes is a major risk factor for heart disease and stroke Acute MI (heart attack) occurs 15 to 20 years earlier in people with diabetes 80% of people with diabetes will die from cardiovascular disease Diabetes in Ontario, An ICES Practice Atlas, 2002

9. Diabetes is the leading cause of non- traumatic amputation Increases the risk of amputation by 20 fold Diabetes in Ontario, An ICES Practice Atlas, 2002 Amputation

10. MacrovascularMicrovascular Stroke Heart disease and hypertension Ulcers and amputation Diabetic eye disease (retinopathy and cataracts ) Renal disease (Kidney) Neuropathy Foot problems Peripheral vascular disease Diabetes Complications

11. Diabetes is the leading cause of adult-onset blindness Prevalence of diabetic retinopathy: –70% in people with type 1 diabetes –40% with person with type 2 diabetes Increased risk of macular edema, cataracts, glaucoma Diabetes in Ontario, An ICES Practice Atlas, 2002 Retinopathy

13. Diabetes is the leading cause of kidney failure (end-stage renal disease) Increases the risk of developing ESRD by up to 13-fold Potent predictor of CVD Parchman ML, et al Medical Care 2002; 40(2):137-144 Nephropathy

14. Skin infections Digestive problems Thyroid problems (hypothyroidism) Sexual dysfunction in men (50-70% of all male diabetes patients suffer from erectile dysfunction) Urinary tract and vaginal infections Carpal tunnel syndrome Diabetes Complications: Other Problems CDA, 2003 www.diabetes.ca

15. The Scope of the Problem World-wide and Canada

16. The Worldwide Epidemic: Diabetes Trends www.who.int www.idf Zimmet P. et al Nature: 414, 13 Dec 2001

17. Why the Epidemic? Physical Inactivity –60% to 85% of adults are not active enough to maintain their health Diet –Calorie dense; high fat Aging population Urbanization –Shift from an agricultural to an urban lifestyle means a decrease in physical activity

18. The Canadian Epidemic The Canadian population is aging –Boomer and Echo generations Immigration and ethnicity –High percentage (77%) of Canadian immigrants are from ethnic groups that are at high risk for the development of diabetes Latino, Hispanic South East Asian Asian African - Growth in Aboriginal populations

19. The Canadian Epidemic: Age Distribution of Canadians with Diabetes in 2000 & 2016 * Source: Statistics Canada

20. Cost of diabetes in Canada –2002:$13.2 billion –2010:$15.2 billion –2020:$19.2 billion Cost of Diabetes

22. Portion Size: 1950s to 2000

23. The Economist, December 13 th -19 th, 2003 Millions of years < 30 years

25. Screening and Prevention Glycemic Management Targets Monitoring Treatment paradigm Macrovascular Complications BP and lipid targets Revisiting the Guidelines

26. A Growing Divide EvidenceBehaviour How can we facilitate translating science to better outcomes?

27.  -Cell Function (%) * Postprandial Hyperglycemia IGT † Type 2 Diabetes Phase I Type 2 Diabetes Phase II Type 2 Diabetes Phase III 25 100 75 0 50 -12-10-6-20261014 Years From Diagnosis Patients treated with insulin, metformin, sulfonylureas ‡ Lebovitz HE. Diabetes Rev. 1999;7:139-153. UKPDS:  -Cell Loss Over Time

28. Diabetes Management (It’s Not Just About Blood Glucose)

29. General Principles of Care Multidisciplinary team approach Care must be systematic –Use clinical flow charts –Institute diabetes mini clinics –Computer data bases assist with physician and patient recall Sporadic reactive care is less effective in preventing complications

30. Patients (and Physicians): “Know Your Targets” Diabetes ABCs A 1C:≤7.0% (or ≤6.0%) B P:≤130/80 mm Hg C holesterol: LDL-C <2.5 mmol/L Management of diabetes requires attention to all factors that increase the risk of complications

31. Glycemic Management

32. Blood Glucose Targets* A1C (%)FPG (mmol/L) 2hPG (mmol/L) Target for most people with DM ≤7.04 - 75 - 10 Normal (if safely achievable) ≤6.04 - 65 - 8 * Treatment goals and strategies must be tailored to the patient, with consideration given to individual risk factors.

33. A1C & Complications Per 1%  A1C Any DM endpoint: 21%  (p<0.0001) Deaths related to DM: 21%  (p<0.0001) All-cause mortality: 14%  (p<0.0001) 5678910 1 4 1 4 1 4 Hazard ratio Updated mean A1C (%) Stratton et al. UKPDS 50. Diabetologia 2001;44:156-63.

34. + complex insulin regimen 7 6 9 8 HbA 1c (%) 10 Diagnosis +5 yrs +10 yrs +15 yrs Duration of diabetes + OAD monotherapy Diet & Exercise + OAD combination + OAD + basal insulin Treat to Fail: Traditional Stepwise Approach

35. 7 6 9 8 HbA 1c (%) Diagnosis +5 yrs +10 yrs +15 yrs Duration of diabetes OAD + basal insulin complex insulin regimen Diet & Exercise + OAD combination Treat to Succeed: Early Combination Approach

36. 0 6 7 8 9 246810 A1C (%) Years from randomization Upper limit of of normal = 6.2% Conventional Glyburide Chlorpropamide Metformin Insulin 0 UKPDS Demonstrated Loss of Glycemic Control With All agents Studied UK Prospective Diabetes Study Group. UKPDS 34. Lancet 1998; 352:854–865. Overweight patients Cohort, median values

37. Treatment Paradigm Target euglycemia as early as possible (within 6-12 months) Tailor an individual regimen for each patient Consider initial combination therapy, especially with marked hyperglycemia (A1C >9%) Early and appropriate use of insulin

38. Polypharmacy A reality in modern diabetes management

39. Diabetes Medications In order to reach A1C, BP and lipid targets, people with diabetes typically require many medications: To lower blood glucose: 1-3 pills and/or insulin To lower cholesterol: 1 or 2 pills To lower blood pressure: 2 or 3 pills For general vascular protection: aspirin Adherence to complex drug regimens can be a challenge for patients.

40. A solution to help improve adherence…

41. The Pill Burger

42. Who is Providing DM Care? Hux JE et al. Diabetes in Ontario, an ICES Practice Atlas, 2003

43. DICE: Diabetes in Canada Evaluation

44. DICE Study Overview The objective of the DICE study was to examine the management and control of type 2 diabetes in Canada. A national, cross-sectional patient chart audit: –Each physician asked to complete short 2-page diary for each of their next 10 patients with type 2 diabetes. –September 2002 to January 2003 Investigator-directed research project –Dr. Stewart Harris, University of Western Ontario, –Dr. Jean-Marie Ekoé, University of Montreal 243 primary-care physicians completed the entire study and contributed 2,473 patient diaries

45. Contact with the Healthcare System in the Past Year Total Mean visits to Family Practice clinic (n = 2145) 8.2 Mean visits to clinic for diabetes-related issues (n = 2136) 4.3 Percentage hospitalized or visited ER for diabetes-related complications (n = 1,944) 8% Patients averaged eight FP visits in the past year and half of visits were for diabetes-related issues.

46. Glycemic Control in Canada One in two type 2 diabetes patients in Canada are not at target (< 7%). Mean A1C = 7.3% Controlled A1c 51% Uncontrolled A1c 49% Most recent A1C test results (n = 2,337)

47. Glycemic Control Over Duration of Disease Control erodes the longer patients have type 2 diabetes and only 38% of patients who have had diabetes for 15+ years are well controlled. Patients at target (%) (A1c < 7%) 100 80 60 40 20 0 15+ years (n = 310) 10-14 years (n = 364) 6-9 years (n = 455) ≤ 2 years (n = 449) 3-5 years (n = 591) 38% 33% 47% 69% 58%

48. Glycemic Management Total Sample2,473 Lifestyle only15% 1 oral agent - no insulin36% 2 oral agents - no insulin30% 3+ oral agents - no insulin8% Insulin only - No oral agents6% 1 oral agent + insulin3% 2+ oral agents + insulin2% 51% of patients using lifestyle modifications or one oral agent only

49. Glycemic Management: Drug Class 61% 48% 15% 4% 12% 15% Patients currently taking medication (%) Base: Patients (n = 2,473) Sulfonylureas include: Glimepiride, glyburide, chloropropamide, gliclazide, tolbutamide. TZDs include: Pioglitazone, rosiglitazone. Other oral agents include: Repaglinide, acarbose, nateglinide. Most patients are managed with traditional agents. Metformin Sulfonylureas net TZDs net Other oral agents net Insulin Lifestyle only

50. Major Challenges to Improving A1c For Patients Not at Target Total Sample1,128 Compliance with diet72% Compliance with exercise71% Lack of interest37% Comorbid conditions35% Compliance with glucose monitoring35% Compliance with medications24% Knowledge21% Multiple medications16% Cultural14% Drug coverage13% No challenges6% Non-compliance with lifestyle modifications are the major barriers to achieving A1c targets. Patients with most recent A1c ≥ 7.0 and have target A1c

51. Total Sample1,128 No action5% Reinforce lifestyle79% More aggressive treatment plans (NET)56% Increase dose oral antihyperglycemic agents28% Add oral antihyperglycemic agents18% Refer to specialist13% Increase insulin dose10% Add insulin6% Plans to Achieve Target More aggressive treatment is planned for only half of these patients. Patients with most recent A1c ≥ 7.0 and have target A1c

52. Glycemic Control and Disease Burden 0 10 20 30 40 50 60 70 80 90 100 Treatment strategies may not be aggressive enough to control all patients, particularly those who have had the disease the longest. ≤ 2 years3 - 5 years6 - 9 years10 - 14 years15+ years Macrovascular complications Microvascular complications Patients (%) A1C ≥ 7% 17% 21% 31% 22% 32% 42% 25% 42% 53% 32% 44% 67% 52% 62%

53. High Disease Burden The burden associated with type 2 diabetes in Canada is high for patients and physicians managing this complex disease. Base: Patients (n = 2,473) Macrovascular conditions include stable angina, MI, CHF, prior stroke, peripheral vascular disease, left ventricular hypertrophy Microvascular conditions include microalbuminuria, cataracts neuropathy, diabetic retinopathy, nephropathy, diabetic foot disease, prior amputation * Among men 63% 59% 28% 38% HypertensionDyslipidemiaMacrovascular Conditions Microvascular Conditions

54. Other Medications (non-antihyperglycemic agents) Base: Patients (n = 2,473) Antihypertensive agents = ACE inhibitors, diuretics, CCBs, beta-blockers, ARBs. Choleserol-lowering agents = Statins, fibrates, niacin. Other heart-related agent = ASA, coronary vasodilator, antiplatelet, anticoagulant. Other medications = Thyroid replacement therapy, antidepressant, HRT therapy, anti-obesity. Taking multiple medications may be a complex burden for the type 2 diabetic patient. Anti-hypertensive agents** Cholesterol-lowering agents** Other heart-related agents** Other medications 73% 51% 56% 24% Patients currently taking medication (%)

55. DICE Summary In Canada, 1 in 2 patients with type 2 patients are not at target, suggesting that current treatment approaches in family practice are not intensive enough. Type 2 diabetes is a complex disease with a high disease burden even within the first 2 years of diagnosis. DICE suggests that with duration of diabetes, glycemic control erodes and morbidity increases among Canadian patients. Physicians are cognizant of Clinical Practice Guideline glycemic targets, but this knowledge does not necessarily translate into action. To help delay or even prevent complications earlier aggressive treatment is needed for type 2 diabetes patients in Canada.