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Jay S Skyler on behalf of the Global Partnership for Effective Diabetes Management Reducing Risk in Type 1 Diabetes – A Practical Approach This slideset.

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Presentation on theme: "Jay S Skyler on behalf of the Global Partnership for Effective Diabetes Management Reducing Risk in Type 1 Diabetes – A Practical Approach This slideset."— Presentation transcript:

1 Jay S Skyler on behalf of the Global Partnership for Effective Diabetes Management Reducing Risk in Type 1 Diabetes – A Practical Approach This slideset was developed in 2009 with support from GlaxoSmithKline

2 Global Partnership for Effective Diabetes Management: Identifying and addressing gaps in T1DM care There are considerable gaps in care of adults with T1DM: –High proportion continue to develop complications –Majority do not achieve glycemic goals –Patients face many challenges e.g. insulin dose adjustment, hypoglycaemia, impact on daily life Aschner P, et al. Int J Clin Pract 2009: in press.

3 Global Partnership for Effective Diabetes Management: Identifying and addressing gaps in T1DM care The Global Partnership has developed practical guidance to improve care in T1DM by addressing: –management of hyperglycemia –insulin therapy –management of CV risk factors –psychological aspects –team approach to care Aschner P, et al. Int J Clin Pract 2009: in press.

4 Importance of management of hyperglycemia

5 DCCT: Early intensive therapy reduced the incidence of retinopathy and microalbuminuria in T1DM Cumulative incidence of retinopathy progression Cumulative incidence of microalbuminuria Time (years) Patients (%) Conventional Intensive Time (years) Conventional Intensive Patients (%) DCCT Research Group. N Engl J Med 1993; 329:977–986. *Intensive vs conventional treatment Median HbA1c during 6.5 year follow-up period: intensive group, 7.3%; conventional group, 9.1%. N = % risk reduction*39% risk reduction* Copyright 1993 Massachusetts Medical Society. All rights reserved.

6 Cumulative incidence of retinopathy over 10 years in EDIC following DCCT: the ‘legacy effect’ White NH, et al. Arch Ophthalmol 2008; 126:1707–1715. Error bars are 95% CI. N = 1211 Conventional Intensive 53% risk reduction with intensive therapy, 95% CI, 43%–61%; P < EDIC study year DCCT closeout P < Conventional Intensive Cumulative incidence, % HbA1c (%) Copyright © 2008 American Medical Association. All rights reserved.

7 57% risk reduction in non-fatal MI, stroke or CVD death* Intensive treatment Cumulative incidence of non-fatal MI, stroke or death from CVD Conventional treatment Years DCCT (intervention period) EDIC (observational follow-up) *Intensive vs conventional treatment. N = 1441 DCCT/EDIC Study Research Group. N Engl J Med 2005; 353:2643–2653. DCCT/EDIC: glycemic control reduces macrovascular complications in T1DM Copyright 2005 Massachusetts Medical Society. All rights reserved.

8 Clinic vs ‘real-world’ data: incidence of proliferative retinopathy (DCCT-EDIC/EDC) DCCT/EDIC Research Group. Arch Intern Med 2009; 169:1307–1316. Cumulative incidence of proliferative retinopathy or worse EDC DCCT – Conventional therapy DCCT – Intensive therapy Diabetes duration, years Cumulative incidence, % Copyright © 2009 American Medical Association. All rights reserved.

9 Nephropathy was defined as albumin excretion rate ≥ 300 mg/24 h, serum creatinine ≥ 2 mg/dl, or dialysis or renal transplant EDC DCCT – Conventional therapy DCCT – Intensive therapy Diabetes duration, years Cumulative incidence, % DCCT/EDIC Research Group. Arch Intern Med 2009; 169:1307–1316. Clinic vs ‘real-world’ data: incidence of nephropathy (DCCT-EDIC/EDC) Copyright © 2009 American Medical Association. All rights reserved.

10 Clinic vs ‘real-world’ data: incidence of CVD (DCCT-EDIC/EDC) CVD was defined as: non-fatal myocardial infarction or stroke, CVD death, subclinical MI, angina, angioplasty or coronary artery bypass EDC DCCT – Conventional therapy DCCT – Intensive therapy Diabetes duration, years Cumulative incidence, % DCCT/EDIC Research Group. Arch Intern Med 2009; 169:1307–1316. Copyright © 2009 American Medical Association. All rights reserved.

11 Management of hyperglycemia

12 CharacteristicADACDAIDFNICE (UK) HbA1c< 7.0%≤ 7.0%6.2–7.5%≤ 6.5–7.5% Fasting⁄ preprandial glucose, mg⁄dl (mmol/l) 70–130 (3.9–7.2) 72–126 (4.0–7.0) 91–120 (5.1–6.5) 72–144 (4.0–8.0) Postprandial glucose, mg⁄dl (mmol/l) < 180* (< 10.0) 90–180 † (5.0–10.0) 136–160 ‡ (7.6–9.0) < 180 ‡ (< 10.0) ADA = American Diabetes Association; CDA = Canadian Diabetes Association; IDF = International Diabetes Federation; NICE = National Institute for Health and Clinical Excellence The CDA guidelines note that HbA1c goals and strategies must be tailored to the individual with diabetes, with consideration given to individual risk factors. ADA and CDA glycaemic targets are for type 1 and type 2 diabetes. * Peak postprandial capillary plasma glucose. † 90–144 mg/dl (5.0–8.0 mmol/l) if HbA1c target not being met. ‡ Capillary postprandial glucose 1–2 h after meal. ADA. Diabetes Care 2009; 32(Suppl. 1):S13–S61. CDA. Can J Diabetes 2008; 32(Suppl. 1):S1–S201. IDF. Desktop guide to Type 1 (insulin-dependent) diabetes, 1998; Brussels: IDF. NICE. Clinical Guideline ; London, UK: NICE. Glycemic targets for individuals with T1DM

13 Majority of patients with T1DM do not reach glycemic targets Percentage not reaching HbA1c target (%) 1. Calvert M, et al. BMJ 2009; 338:b DCCT/EDIC Study Research Group. Arch Intern Med 2009; 169:1307– % 81% 83% 87% UK 1 HbA1c > 7.5% DCCT-EDIC Intensive EDCDCCT-EDIC Conventional US 2 HbA1c > 7.0%

14 Managing hyperglycemia in type 1 diabetes The Global Partnership recommends: Aim for as good glycemic control as possible while minimizing the risk of hypoglycemia Ensure regular and appropriate monitoring for complications Aschner P, et al. Int J Clin Pract 2009: in press.

15 Insulin therapy

16 Intensive insulin therapy using a basal-bolus approach: considered best treatment in T1DM Intensive insulin therapy using a basal-bolus approach, whether as multiple daily injections or pump therapy, is considered best treatment for individuals with T1DM regardless of age –Provides greater glycemic control, reduces risk of complications, preserves β-cell function (DCCT) 1-3 Choice of insulin/mode of delivery should be guided by factors such as: –hypoglycemia, age, lifestyle, general health, motivation, ability for self-management and diet, availability/accessibility 1. DCCT Research Study Group. N Engl J Med 1993; 329:977– DCCT/EDIC Research Study Group. N Engl J Med 2005; 353:2643– DCCT Research Study Group. Ann Intern Med 1998; 128:517–523.

17 C-peptide (nmol/L) Duration of T1DM (years) Mean ± SEM basal (solid) and stimulated (stripes) C-peptide levels shown for 610 patients, mean age 25 years (range 13–39 years). C-peptide levels measured following meal challenge DCCT: C-peptide levels decrease with increasing duration of T1DM Reproduced with permission from DCCT Research Study Group. J Clin Endocrinol Metab 1987; 65:30–36. Basal C-peptide Stimulated C-peptide

18 DCCT: Intensive therapy preserves residual β-cell function DCCT Research Study Group. Ann Intern Med 1998; 128:517–523. Probability of maintaining C-peptide > 0.2 pmol/mL Intensive therapy Conventional therapy EligibilityYear 6Year 5Year 4Year 3Year 2Year Number of patients in each treatment group who were evaluated Intensive Conventional Copyright © 1998 American Medical Association. All rights reserved.

19 StudySMD (random (95% CI)Weight (%)SMD (95% CI) Berg 1998 Ciavarella 1985 DeVries 2002 Ziegler 1990 Oslo Study 1985–1988 Chiasson 1984 Hanaire-Broutin 2000 Home 1982 Hoogma 2006 Saurbrey 1988 Schiffrin 1982 Scmitz 1989 Total (95% CI) (-1.64, -0.20) (-4.43, -1.95) (-1.28, -0.35) 0.16 (-0.36, 0.68) (-1.01, 0.42) 0.33 (-0.47, 1.13) (-1.00, -0.12) (-1.72, 0.04) (-0.40, -0.04) 0.00 (-0.64, 0.64) (-1.10, 0.28) (-2.24, -0.48) (-0.87, -0.22) Jeitler K, et al. Diabetologia 2008; 51:941–951. Favors CSIIFavors MDI HbA1c in T1DM is better with continuous subcutaneous insulin infusion (CSII)

20 Incidence of severe hypoglycemia is reduced with CSII Pickup JC & Sutton AJ. Diabet Med 2008; 25:765–774. StudySevere hypoglycemia rate ratioWeight (%)SMD (95% CI) Bode (poor control) Bode (good control) Kaderman Maniatis Rizvi Litton Linkeschova Bruttomesso Rudolph, Hirsch Plotnik Cohen Hunger-Dathe Weintrob Weinzimer McMahon Siegel-Czarkowski Alemzadeh Mack-Fogg Sciaffini Rodrigues Lepore Hoogma Overall (l 2 = 84.2%, P = 0.00) (3.57, 8.61) (4.24, 26.01) 6.47 (3.09, 13.55) 1.29 (0.31, 5.42) 8.00 (1.84, 34.79) 5.75 (0.72, 45.97) (6.95, 27.86) 3.44 (1.62, 7.33) 3.81 (2.49, 5.84) 2.18 (1.05, 4.52) 4.69 (0.52, 41.98) 3.62 (2.23, 5.85) 3.00 (0.62, 14.44) 2.11 (1.50, 2.96) 2.89 (1.67, 4.98) 7.07 (0.87, 57.46) 2.51 (0.67, 9.47) 2.09 (1.12, 3.92) 1.25 (0.34, 4.65) (29.94, 57.15) 3.50 (2.04, 6.01) 2.50 (1.53, 4.08) 4.19 (2.86, 6.13) Favors MDIFavors CSII Reprinted by permission of John Wiley & Sons, Inc.

21 Initiation of insulin Initiate basal-bolus regimen as early as possible The Global Partnership recommends: Provide all patients with a structured educational programme at initiation of insulin and thereafter Aschner P, et al. Int J Clin Pract 2009: in press.

22 Adjusting insulin dosages: practical barriers facing individuals with T1DM Patients must adjust insulin doses in response to many factors to minimize risk of hypo- or hyperglycemia: –carbohydrate intake, lifestyle, exercise, intercurrent illness Modification of insulin dosages based on diet and exercise should be considered an essential part of patient education –adapted to local diet and lifestyle Patients may not know the effect of factors such as exercise or alcohol on glucose levels and need for appropriate adjustment of insulin therapy –64% of patients with T1DM do not achieve recommended physical activity levels due to barriers such as fear of hypoglycaemia 1,2 1. Brazeau AS, et al. Diabetes Care 2008; 31:2108– Plotnikoff RC, et al. Med Sci Sports Exerc 2006; 38:1526–1534.

23 Modification of insulin dosages based on diet and exercise: DTTP study HbA 1c (%) Severe hypoglycemic episodes (events per patient-year) Baseline1 yearBaseline1 year Mean difference: –0.7% (95% CI –0.9 to –0.6%, P < ) Mean difference: −0.21 events per patient-year (95% CI −0.32 to −0.11, P = ) Dusseldorf Diabetes Treatment and Teaching Programme (DTTP): N = 9,583. Samann A, et al. Diabetologia 2005; 48:1965–1970. HbA 1c Severe hypoglycemia

24 Precipitating causes of DKA Precipitating factor Percentage of cases Infection 28–43% Omission/reduction of insulin dose 13–45% First presentation of diabetes 10–20% Myocardial infarction 1% No cause identified <40% Wallace TM & Matthews DR. QJM 2004; 97:773–780. Reprinted by permission of Oxford University Press.

25 Self-monitoring blood glucose (SMBG): a fundamental aspect of insulin therapy SMBG is so fundamental that insulin therapy should always comprise insulin therapy plus SMBG Despite clear benefits, up to 64% of patients do not regularly self-monitor 1 Barriers include patient motivation, psychological barriers, cost, socioeconomic status, education Patients should receive appropriate training in SMBG when insulin therapy is initiated and periodically thereafter 1. DCCT/EDIC Research Study Group. Arch Intern Med 2009; 169:1307–1316.

26 SMBG ≥ 3-times per day associated with better glycemic control in T1DM Reproduced from Karter AJ, et al. Am J Med 2001; 111:1–9. Adjusted HbA1c by strip use (average strips per day) Estimated HbA1c (%) 9.5 No utilizationLess than daily DailyAt least 3x daily Copyright 2001 with permission from Elsevier.

27 JDRF study: Sustained HbA1c lowering in T1DM patients with HbA1c >7.0% using CGM Treatment time (months) JDRF CGM Study Group. Diabetes Care 2009; 32: 2047–2049. HbA1c (%)

28 JDRF study: Maintained HbA1c with less hypoglycemia in T1DM patients with HbA1c < 7.0% using CGM Treatment time (months) HbA1c (%) JDRF CGM Study Group. Diabetes Care 2009; 32: 2047–2049.

29 Self-monitoring of blood glucose Ensure that self-monitoring is universally adopted as an integral part of insulin therapy The Global Partnership recommends: Aschner P, et al. Int J Clin Pract 2009: in press.

30 Hypoglycemia: can affect many aspects of care in T1DM In DCCT, severe hypoglycemia three times higher with intensive vs conventional therapy 1,2 Almost one-third of patients who experience severe hypoglycemia have a second episode within 4 months 2 Almost half of severe hypoglycemic episodes occur at night 1 Risk factors include strict glycemic control, prior episode of severe hypoglycemia, longer duration of diabetes, autonomic neuropathy, hypoglycemia unawareness In the DCCT, intensively treated patients with greater residual β-cell function had a significantly lower rate of hypoglycemia vs those with less/no residual β-cell function 3 1. DCCT Research Study Group. Am J Med 1991; 90:450– DCCT Research Group. Diabetes 1997; 46:271– Steffes M, et al. Diabetes Care 2003; 26:832–836.

31 Conventional Intensive HbA1c (%) during study Rate per 100 years DCCT: Risk of severe hypoglycemia versus HbA 1c in intensive and conventional groups DCCT Research Study Group. Diabetes 1997; 46:271–286. N = 1,441 Copyright 1997 American Diabetes Association. Reprinted with permission from The American Diabetes Association.

32 Incidence of hypoglycemia in the DCCT Rate of hypoglycemia ± SE per 100 participant-years* Steffes M, et al. Diabetes Care 2003; 26:832–836. UndetectableMinimalBaseline-onlySustained *Both treatment groups (intensive and conventional therapy). Undetectable  0.03 nmol/L; minimal 0.04–0.20 nmol/L; baseline-only (> 0.2 nmol/L at baseline, 0.2 nmol/L at baseline and  1 year later). Rates were compared (horizontally) between stimulated C-peptide groups. Rates between all groups were significantly different (P < 0.05), except comparison between minimal and baseline-only group Stimulated C-peptide group Copyright 2003 American Diabetes Association. Reprinted with permission from The American Diabetes Association.

33 Effect of impaired awareness of hypoglycemia in T1DM Subjects (%) Percentage Events Awareness of hypoglycemia: Normal Impaired Geddes J, et al. Diabetic Med 2008; 25:501–504. Number of events per year

34 Hypoglycemia Provide education about prevention, recognition and treatment of hypoglycemia at initiation of insulin therapy and thereafter The Global Partnership recommends: Aschner P, et al. Int J Clin Pract 2009: in press.

35 Management of CV risk factors

36 Higher absolute risk of CVD in T1DM at younger age in men and women Soedamah-Muthu SS, et al. Diabetes Care 2006; 29:798–804. MEN Absolute CVD risk per 1000 person-years WOMEN Absolute CVD risk per 1000 person-years T1DMWithout diabetesT1DMWithout diabetes ≤35 years 0.8 ( )0.07 ( )0.5 ( )0.05 ( ) years 4.8 ( )1.1 ( )3.5 ( )0.2 ( ) years 10.6 ( )3.6 ( )10.2 ( )1.1 ( ) years 35.2 ( )15.3 ( )38.7 ( )4.9 ( ) >75 years ( )34.2 ( )87.3 ( )28.2 ( ) Copyright 2006 American Diabetes Association. Reprinted with permission from The American Diabetes Association.

37 Blood pressure, lipid and aspirin therapy Study SBP mmHg LDL-C mmol/L (mg/dL)On statins, %On aspirin, % ACCORD 1,4 127/ (91)8876 ADVANCE 2,4 136/ (102)4756 VADT 3,4 127/ (80)8487 SBP = systolic blood pressure; LDL-C = LDL-cholesterol 1. ACCORD Study Group. N Engl J Med 2008; 358:2545– ADVANCE Collaborative Group. N Engl J Med 2008; 358:2560– Duckworth W, et al. N Engl J Med 2009; 360:129– Skyler JS, et al. Diabetes Care 2009; 32:187–192.

38 Patients with T1DM of ≥ 15 years’ duration and aged >30 should be considered at high risk of CVD Managing cardiovascular risk factors CDA. Can J Diabetes 2008; 32(Suppl. 1):S1–S201.

39 Other risk factors Manage all CV risk factors The Global Partnership recommends: Aschner P, et al. Int J Clin Pract 2009: in press.

40 Psychological aspects

41 Depressive symptoms significantly related to HbA1c in T1DM Reproduced with permission from Van Tilburg MA, et al. Psychosom Med 2001; 63:551–555. Beck Depression Inventory (BDI) score Significant positive relationship between BDI score and HbA1c (r = 0.44, P < 0.02) BDI score ≥16 indicates possible clinical depression HbA1c (%)

42 Disordered eating behavior associated with higher risk of retinopathy & nephropathy in young women with T1DM Rydall AC, et al. N Engl J Med 1997; 336:1849–1854. Disordered-eating status at baseline Diabetic retinopathy at follow-up* Abnormal urinary albumin excretion at follow-up Highly disordered86% (6/7)43% (3/7) Moderately disordered43% (6/14)20% (3/15) Nondisordered24% (12/50) 18% (9/50) Values are % (n with complications/total n) Mean age at baseline (±SD): 15±2 years (range 12–18) Copyright 1997 Massachusetts Medical Society. All rights reserved.

43 Psychological aspects of type 1 diabetes Explore psychological issues associated with type 1 diabetes and treat/refer, as appropriate The Global Partnership recommends: Aschner P, et al. Int J Clin Pract 2009: in press.

44 Team approach to care

45 A multidisciplinary approach to care Many complexities involved in treating patients with T1DM Adopting a team approach that involves a broad range of disciplines is essential Where possible, team should include: patient, diabetes specialist, primary care physician, nurse, dietitian, podiatrist and psychologist/psychiatrist, as well as family and friends. All members of the team should work together to ensure continuity of care Aschner P, et al. Int J Clin Pract 2009: in press.

46 A team approach to diabetes care Adopt a multidisciplinary team approach with shared goals and recommendations The Global Partnership recommends: Aschner P, et al. Int J Clin Pract 2009: in press.

47 Practical recommendations for the management of adults with T1DM Aim for as good glycemic control as possible while minimizing the risk of hypoglycemia Ensure regular and appropriate monitoring for complications Initiate basal-bolus regimen as early as possible Provide all patients with a structured educational programme at initiation of insulin and thereafter Ensure that self-monitoring is universally adopted as an integral part of insulin therapy Aschner P, et al. Int J Clin Pract 2009: in press.

48 Practical recommendations for the management of adults with T1DM Provide education about prevention, recognition and treatment of hypoglycaemia at initiation of insulin therapy and thereafter Manage all CV risk factors Explore psychological issues associated with T1DM and treat/refer, as appropriate Adopt a multidisciplinary team approach with shared goals and recommendations Aschner P, et al. Int J Clin Pract 2009: in press.


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