Microvascular Disease in Type 1 Diabetes

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1 Microvascular Disease in Type 1 Diabetes Jay S. Skyler, MD, MACP Division of Endocrinology, Diabetes, and Metabolism and Diabetes Research Institute University of Miami Miller School of Medicine

2 The Course of Type 1 Diabetes 100% Genetic Susceptibility Inciting Event(s) Silent Cell Loss Diabetes Onset Total Diabetes Islet Cell Mass 50% Complications 0% Time (years)

3 Burden of Diabetes Diabetic Retinopathy #1 Cause of Blindness in Working Age Adults Diabetic Nephropathy #1 Cause of End Stage Renal Disease Diabetic Amputations # 1 Cause of Non-traumatic Lower Extremity Amputations Diabetic Vascular Disease 2-to-6-Fold More Likely to Have Heart Disease National Diabetes Information Clearinghouse. National Diabetes Statistics, 2011 Available at:

4 DRS: Cumulative Rates of Severe Visual Loss From Proliferative Diabetic Retinopathy 40 Control Event Rates/ Treated Follow-up (Months) Ophthalmology 1981;88:

5 DCCT

6 A1c During DCCT DCCT Intervention Conventional mean A1c 9.1% 9 A1c (%) Intensive mean A1c 7.2% Study Year

7 DCCT Retinopathy Progression Primary Prevention Cohort 100% Cumulative Incidence (%) 80% 60% 40% 20% 0% p< Years Conventional Group Intensive Group DCCT. NEJM 1993; 329:977

8 DCCT Retinopathy Progression Secondary Intervention Cohort 100% Cumulative Incidence (%) 80% 60% 40% 20% 0% p< Years Conventional Group Intensive Group DCCT. NEJM 1993; 329:977

9 DCCT: Microalbuminuria & Macroalbuminuria Primary Prevention Cohort Percentage of Patients Conventional Intensive Microalbuminuria > 40 mg/24 h Albuminuria 300 mg/24 h P< 0.04 P= Year of Study DCCT (1993) NEJM 329:

10 DCCT: Microalbuminuria and Macroalbuminuria Secondary Intervention Cohort Percentage of Patients Conventional Intensive Microalbuminuria 40 mg/24 h P= P= 0.01 Albuminuria 300 mg/24 h Year of Study DCCT (1993) NEJM 329:

11 DCCT-EDIC

12 A1c During DCCT and EDIC 11 DCCT Intervention Conventional mean A1c 9.1% Training EDIC Observation 10 9 Conventional mean A1c 8.2% A1c (%) Intensive mean A1c 7.2% Intensive mean A1c 8.0% Study year EDIC = Epidemiology of Diabetes Interventions and Complications Nathan DM, et al. N Engl J Med 2005;353;

13 Distribution of A1c in the Former DCCT Intensive & Conventional Groups During EDIC Conventional Intensive A1c (%) p < DCCT Closeout EDIC year JAMA 2003; 290:

14 HbA1c by DCCT Treatment Group at the end of the DCCT and at Each of the First 10 years of EDIC DCCT-EDICResearch Group, Arch Ophthalmol 2008;126:

15 Cumulative incidence of further 3-step progression of retinopathy from DCCT closeout to EDIC study year 10 (adjusted for retinopathy level at DCCT end, cohort, entry HbA1c, baseline diabetes duration) DCCT-EDICResearch Group, Arch Ophthalmol 2008;126:

16 Cumulative incidence of proliferative retinopathy or worse from DCCT closeout to EDIC study year 10 (adjusted for retinopathy level at DCCT end, cohort, entry HbA1c, baseline diabetes duration) DCCT-EDICResearch Group, Arch Ophthalmol 2008;126:

17 Clinic vs Real-world Data: Incidence of Proliferative Retinopathy (DCCT-EDIC/EDC) Cumulative Incidence (%) Diabetes Duration (years) DCCT Conventional therapy EDC DCCT Intensive therapy Cumulative incidence of proliferative retinopathy or worse DCCT/EDIC Research Group. Arch Intern Med 2009;69:

18 Prevalence of Diabetic Retinopathy in Type 1 Diabetes Wisconsin Epidemiological Study of Diabetic Retinopathy: WESDR Prevalence (%) Any Retinopathy Proliferative Retinopathy Duration of Diabetes (years) Klein R, et al, Arch Ophthalmol ;102:

19 Cumulative Incidence of Severe Retinopathy in Childhood T1D According To Long-Term Glycemia 80 Cumulative Proportion (%) Linkoping HbA1c < 7.6% HbA1c % HbA1c % HbA1c 9.6% ** Duration of Diabetes (years) Nordwall et al. Ped Diab 2009;10:168-76

20 Cumulative Incidence of Laser-Rx Rx d d DR in T1D with Onset Age < 15 Years, According To Year of Onset 70 Linkoping Cumulative Proportion (%) Overall p = Duration of Diabetes (years) Nordwall et al. Diabetologia 2004;47:

21 Retinopathy Diabetes is leading cause of new cases of blindness among adults ages years Of people with diabetes aged 40 years, 4.2 million (28.5%) had diabetic retinopathy in ,000 (4.4% of those with diabetes) had advanced diabetic retinopathy that could lead to severe vision loss (15.7% of those with retinopathy) National Diabetes Information Clearinghouse. National Diabetes Statistics, 2011 Available at:

22 Cumulative Incidence of New Microalbuminuria > 40 mg/24 h During EDIC Cumulative Incidence (%) % risk reduction p <.0001 Conventional Intensive EDIC Year JAMA 2003; 290:

23 Cumulative Incidence of New Clinical Albuminuria > 300 mg/24 h During EDIC Cumulative Incidence (%) % risk reduction p <.0001 Conventional Intensive EDIC Year JAMA 2003; 290:

24 Estimated GFR over Time DCCT/EDIC Research Group. N Engl J Med 2011;365:

25 Cumulative Incidence of an Impaired Glomerular Filtration Rate, According to Treatment Group. DCCT/EDIC Research Group. N Engl J Med 2011;365:

26 Impaired GFR Can Develop Without Albuminuria Cumulative Incidence Albuminuria Status Time from randomization (years) 10 0 Normo Micro Macro Molitch M et al, Diabetes Care 2010

27 Glycemic Control Prevents Albuminuria de Boer IH et al, Arch Int Med 2011

28 Microalbuminuria Can Regress de Boer IH et al, Arch Int Med 2011

29 Clinic vs Real-world Data: Incidence of Nephropathy (DCCT-EDIC/EDC) Cumulative incidence, % DCCT Conventional therapy EDC DCCT Intensive therapy Diabetes duration, years Nephropathy defined as albumin excretion rate 300 mg/24 h, serum Cr 2 mg/dl, dialysis or renal transplant DCCT/EDIC Research Group. Arch Intern Med 2009; 169:

30 Cumulative Incidence of the First of Any of the Predefined CVD Outcomes Cumulative Incidence of Any Predefined CV Outcome Risk reduction 42% 95% CI: Log-rank p=0.016 Conventional treatment Intensive treatment No. at Risk Years Since Entry Intensive Conventional Nathan DM, et al. N Engl J Med 2005;353;

31 Cumulative Incidence of the First Occurrence of Non-fatal MI, Stroke, or Death from CVD Cumulative Incidence of Non-fatal MI, Stroke, or Death from CVD Risk reduction 57% 95% CI: Log-rank p=0.018 Conventional treatment Intensive treatment No. at Risk Years Since Entry Intensive Conventional Nathan DM, et al. N Engl J Med 2005;353;

32 Clinic vs Real-world Data: Incidence of CVD (DCCT-EDIC/EDC) Cumulative incidence, % DCCT Conventional therapy EDC DCCT Intensive therapy Diabetes duration, years CVD was defined as: non-fatal myocardial infarction or stroke, CVD death, subclinical MI,, angina, angioplasty or coronary artery bypass DCCT/EDIC Research Group. Arch Intern Med 2009; 169:

33 DCCT: Absolute Risk of Severe Hypoglycemia by Mean A1c 120 Rate of severe Hypoglycemia (per 100 patient-years) DCCT: 1986 to Glycosylated Hemoglobin (%) DCCT. N Engl J Med 1993;329:977-86

34 Two Eras of Diabetes Management 120 Rate of severe Hypoglycemia (per 100 patient-years) JDRF CGM Study Control Group DCCT: 1986 to Glycosylated Hemoglobin (%) DCCT. N Engl J Med 1993;329: JDRF. N Engl J Med 2008;359:

35 What was different? Insulin Analogs!!

36 Ideal Basal/Bolus Insulin Absorption Pattern

37 Impact of Continuous Glucose Monitoring on Rate of Severe Hypoglycemia Compared to DCCT Rate of severe Hypoglycemia (per 100 patient-years) Age 25 years with A1C < 7.0% Age years with A1C < 7.0 % Age years with A1C < 7.0% Age 25 years with A1C 7.0% Age years with A1C 7.0% Age years with A1C 7.0% Glycosylated Hemoglobin (%) JDRF. N Engl J Med 2008;359:

38 Modern Approaches Can Achieve Meticulous Control Without Much Risk

39 Burden of Diabetes Diabetic Retinopathy #1 Cause of Blindness in Working Age Adults Diabetic Nephropathy #1 Cause of End Stage Renal Disease Diabetic Amputations # 1 Cause of Non-traumatic Lower Extremity Amputations Diabetic Vascular Disease 2-to-6-Fold More Likely to Have Heart Disease National Diabetes Information Clearinghouse. National Diabetes Statistics, 2011 Available at:

40 Cumulative CAD Mortality In T1D 60 Males Cumulative Mortality (%) Females Joslin T1D Cohorts Framingham Cohorts Attained Age (years) Krolewski et al. Am J Cardiol 1987; 59:

41 Relative Mortality In T1D With and Without Proteinuria Women with proteinuria Men with proteinuria Relative Mortality Women without proteinuria Men without proteinuria Age (years) Borch-Johnsen et al Diabetologia 1985; 28:

42 Relative Mortality From CVD In T1D With and Without Proteinuria With proteinuria Without proteinuria Relative Mortality Diabetes Duration (years) Borch-Johnsen et al BMJ 1987; 294:

43 Cumulative Incidence CVD In T1D With and Without Proteinuria 40 Cumulative Incidence of Coronary Heart Disease (%) Years After Onset of Proteinuria Jensen et al. Diabetologia 1987; 30:

44 Diabetic Nephropathy and Mortality in Patients with Type 1 Diabetes 1.00 The FinnDiane Study 0.98 Normoalbuminuria Adjusted Survival (%) Microalbuminuria 0.90 Macroalbuminuria Duration of follow-up (years) Groop et al. Diabetes 2009; 58,

45 Diabetic Nephropathy and Mortality in Patients with Type 1 Diabetes The FinnDiane Study Groop et al. Diabetes 2009; 58,

46 Pittsburgh EDC 20-yr Mortality Risk in T1D Related to Renal Disease Unadjusted Survival (%) Normal MA ON ESRD Duration of follow-up (years) (%) Orchard et al. Diabetologia 2010;53:

47 Pittsburgh EDC 20-yr Mortality Risk in T1D Related to Renal Disease 40.0 Adjusted Hazard Ratio SMR Normoalbuminuria Microalbuminuria Overt Nephropathy ESRD Orchard et al. Diabetologia 2010;53:

48 Prevalence of Microalbuminuria in Children with T1D, in Relation to Mean Lifetime HbA 1 c Amin R, et al. BMJ 2008;336:

49 Cumulative Incidence of Overt Nephropathy In Childhood T1D According To Long-Term Glycemic Control 50 Linkoping 40 Cumulative Proportion (%) HbA1c <7.6% HbA1c % HbA1c % HbA1c 9.6% *** Duration of Diabetes (years) Nordwall et al. Ped Diab 2009; 10:

50 Incidence Rate of End-stage Renal Disease According To Time Period of Diagnosis of Type 1 Diabetes 10 Finland Incidence Rate, Cases Per 1000 Patients (years) * * * Period of Diagnosis of Type 1 Diabetes * Years After Diagnosis of Type 1 Diabetes Finne, P. et al. JAMA 2005;294:

51 Cumulative incidence of diabetic nephropathy in type 1 diabetes Denmark Cumulative incidence (%) Duration of diabetes (years) (n = 113) ( 1974 (n n = 130) ( 1979 (n n = 113) ( 1984 (n n = 244) Hovind et al. Diabetes Care 2003;26:

52 Cumulative Incidence of Nephropathy Among Patients In Whom T1D Began Before Age 15 Years, According To Year of Onset 50 Linkoping Overall p<0.001 Cumulative Proportion (%) Duration of Diabetes (years) Nordwall et al. Diabetologia 2004; 47:

53 All-Cause Mortality In T1D By Diagnosis Cohort - Pittsburgh Cumulative Survival Diabetes Duration At Death Pambianco et al Diabetes 2006; 55:

54 Modern Approaches Can Reduce Risk of Complications

55

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