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Reducing Risk in Type 1 Diabetes – A Practical Approach

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

2 Aschner P, et al. Int J Clin Pract 2009: in press.
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 Aschner P, et al. Int J Clin Pract 2009: in press.
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 60 54% risk reduction* 60 39% risk reduction* 50 50 40 Conventional 40 Conventional Patients (%) 30 Patients (%) 30 20 20 Intensive Intensive 10 10 1 2 3 4 5 6 7 8 9 1 2 3 4 5 6 7 8 9 Time (years) Time (years) *Intensive vs conventional treatment Median HbA1c during 6.5 year follow-up period: intensive group, 7.3%; conventional group, 9.1%. N = 1441 DCCT Research Group. N Engl J Med 1993; 329:977–986. Copyright 1993 Massachusetts Medical Society. All rights reserved.

6 Cumulative incidence, %
Cumulative incidence of retinopathy over 10 years in EDIC following DCCT: the ‘legacy effect’ 60 Conventional 53% risk reduction with intensive therapy, 95% CI, 43%–61%; P <.001 Intensive 50 40 Cumulative incidence, % 30 20 10 1 2 3 4 5 6 7 8 9 10 12 10 Conventional + HbA1c (%) Intensive 8 + + + + + + + + + + + + + + + + + + + + + 6 P <.001 <.001 <.001 .002 .08 . 12 . 1 2 .64 .84 .36 .01 DCCT 1 2 3 4 5 6 7 8 9 10 closeout EDIC study year Error bars are 95% CI. N = 1211 White NH, et al. Arch Ophthalmol 2008; 126:1707–1715. Copyright © 2008 American Medical Association. All rights reserved.

7 Cumulative incidence of non-fatal MI, stroke or death from CVD
DCCT/EDIC: glycemic control reduces macrovascular complications in T1DM Cumulative incidence of non-fatal MI, stroke or death from CVD Conventional treatment Years 0.06 0.04 0.02 0.00 DCCT (intervention period) EDIC (observational follow-up) 57% risk reduction in non-fatal MI, stroke or CVD death* Intensive treatment *Intensive vs conventional treatment. N = 1441 DCCT/EDIC Study Research Group. N Engl J Med 2005; 353:2643–2653. Copyright 2005 Massachusetts Medical Society. All rights reserved.

8 Clinic vs ‘real-world’ data: incidence of proliferative retinopathy (DCCT-EDIC/EDC)
70 EDC DCCT – Conventional therapy 60 DCCT – Intensive therapy 50 40 Cumulative incidence, % 30 20 10 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 Diabetes duration, years Cumulative incidence of proliferative retinopathy or worse DCCT/EDIC Research Group. Arch Intern Med 2009; 169:1307–1316. Copyright © 2009 American Medical Association. All rights reserved. 8

9 Clinic vs ‘real-world’ data: incidence of nephropathy (DCCT-EDIC/EDC)
40 EDC DCCT – Conventional therapy 35 DCCT – Intensive therapy 30 25 Cumulative incidence, % 20 15 10 5 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 Diabetes duration, years Nephropathy was defined as albumin excretion rate ≥ 300 mg/24 h, serum creatinine ≥ 2 mg/dl, or dialysis or renal transplant DCCT/EDIC Research Group. Arch Intern Med 2009; 169:1307–1316. Copyright © 2009 American Medical Association. All rights reserved. 9

10 Clinic vs ‘real-world’ data: incidence of CVD (DCCT-EDIC/EDC)
20 EDC DCCT – Conventional therapy 18 DCCT – Intensive therapy 15 13 Cumulative incidence, % 10 8 5 3 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 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; 169:1307–1316. Copyright © 2009 American Medical Association. All rights reserved. 10

11 Management of hyperglycemia

12 Glycemic targets for individuals with T1DM
Characteristic ADA CDA IDF NICE (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‡ 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.

13 Majority of patients with T1DM do not reach glycemic targets
87% 83% 81% 74% Percentage not reaching HbA1c target (%) UK1 HbA1c > 7.5% DCCT-EDIC Intensive EDC Conventional US2 HbA1c > 7.0% 1. Calvert M, et al. BMJ 2009; 338:b1870. 2. DCCT/EDIC Study Research Group. Arch Intern Med 2009; 169:1307–1316.

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; 353:2643–2653. 3. DCCT Research Study Group. Ann Intern Med 1998; 128:517–523.

17 Duration of T1DM (years)
DCCT: C-peptide levels decrease with increasing duration of T1DM 0.1 0.2 0.3 0.4 0.5 0.6 Basal C-peptide Stimulated C-peptide C-peptide (nmol/L) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 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 Reproduced with permission from DCCT Research Study Group. J Clin Endocrinol Metab 1987; 65:30–36.

18 DCCT: Intensive therapy preserves residual β-cell function
1 Probability of maintaining C-peptide > 0.2 pmol/mL 0.9 0.8 0.7 0.6 0.5 0.4 0.3 Intensive therapy Conventional therapy 0.2 0.1 Eligibility Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Number of patients in each treatment group who were evaluated Intensive Conventional DCCT Research Study Group. Ann Intern Med 1998; 128:517–523. Copyright © 1998 American Medical Association. All rights reserved.

19 HbA1c in T1DM is better with continuous subcutaneous insulin infusion (CSII)
Study SMD (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) 7.90 4.46 10.17 9.67 7.21 10.41 6.62 12.35 8.60 8.10 100.00 -0.92 (-1.64, -0.20) -3.19 (-4.43, -1.95) -0.81 (-1.28, -0.35) 0.16 (-0.36, 0.68) -0.29 (-1.01, 0.42) 0.33 (-0.47, 1.13) -0.56 (-1.00, -0.12) -0.84 (-1.72, 0.04) -0.22 (-0.40, -0.04) 0.00 (-0.64, 0.64) -0.41 (-1.10, 0.28) -1.36 (-2.24, -0.48) -0.55 (-0.87, -0.22) -5.00 -4.00 -3.00 -2.00 -1.00 1.00 2.00 Favors CSII Favors MDI Jeitler K, et al. Diabetologia 2008; 51:941–951.

20 Incidence of severe hypoglycemia is reduced with CSII
Study Severe hypoglycemia rate ratio Weight (%) 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) 5.84 4.66 5.11 3.34 3.26 2.19 5.23 5.07 5.87 5.13 2.04 5.75 3.04 6.03 5.60 2.17 3.58 5.40 3.61 5.61 5.73 100.00 5.55 (3.57, 8.61) 10.50 (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) 13.92 (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) 35.41 (29.94, 57.15) 3.50 (2.04, 6.01) 2.50 (1.53, 4.08) 4.19 (2.86, 6.13) 0.5 1.0 2.0 5.0 10 25 Favors MDI Favors CSII Pickup JC & Sutton AJ. Diabet Med 2008; 25:765–774. Reprinted by permission of John Wiley & Sons, Inc.

21 Aschner P, et al. Int J Clin Pract 2009: in press.
Initiation of insulin The Global Partnership recommends: Initiate basal-bolus regimen as early as possible 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 hypoglycaemia1,2 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
HbA1c Severe hypoglycemia 10 0.7 0.6 9 0.5 Severe hypoglycemic episodes (events per patient-year) HbA1c (%) 8 0.4 7 0.3 0.2 6 0.1 5 Baseline 1 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.

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-monitor1 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
9.5 Estimated HbA1c (%) 9.0 8.5 8.0 7.5 7.0 No utilization Less than daily Daily At least 3x daily Adjusted HbA1c by strip use (average strips per day) Reproduced from Karter AJ, et al. Am J Med 2001; 111:1–9. Copyright 2001 with permission from Elsevier.

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

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

29 Self-monitoring of blood glucose
The Global Partnership recommends: 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.

30 Hypoglycemia: can affect many aspects of care in T1DM
In DCCT, severe hypoglycemia three times higher with intensive vs conventional therapy1,2 Almost one-third of patients who experience severe hypoglycemia have a second episode within 4 months2 Almost half of severe hypoglycemic episodes occur at night1 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 function3 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 DCCT: Risk of severe hypoglycemia versus HbA1c in intensive and conventional groups
100 80 60 Rate per 100 years 40 20 I n t e n s i v e C o n v e n t i o n a l 5 6 7 8 9 1 1 1 1 2 1 3 1 4 H b A 1 c ( % ) d u r i n g s t u d y N = 1,441 DCCT Research Study Group. Diabetes 1997; 46:271–286. Copyright 1997 American Diabetes Association. Reprinted with permission from The American Diabetes Association.

32 Incidence of hypoglycemia in the DCCT
14.0 Rate of hypoglycemia ± SE per 100 participant-years* 12.0 10.0 8.0 6.0 4.0 2.0 Undetectable Minimal Baseline-only Sustained Stimulated C-peptide group *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 thereafter); sustained (> 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 Steffes M, et al. Diabetes Care 2003; 26:832–836. Copyright 2003 American Diabetes Association. Reprinted with permission from The American Diabetes Association.

33 Effect of impaired awareness of hypoglycemia in T1DM
Normal Impaired 100 2.5 Subjects (%) 80 2.0 60 1.5 Number of events per year 40 1.0 20 0.5 0.0 Percentage Events Geddes J, et al. Diabetic Med 2008; 25:501–504.

34 Aschner P, et al. Int J Clin Pract 2009: in press.
Hypoglycemia The Global Partnership recommends: Provide education about prevention, recognition and treatment of hypoglycemia at initiation of insulin therapy and thereafter 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
MEN Absolute CVD risk per 1000 person-years WOMEN Absolute CVD risk per 1000 person-years T1DM Without diabetes ≤35 years 0.8 ( ) 0.07 ( ) 0.5 ( ) 0.05 ( ) 35-45 years 4.8 ( ) 1.1 ( ) 3.5 ( ) 0.2 ( ) 45-55 years 10.6 ( ) 3.6 ( ) 10.2 ( ) 1.1 ( ) 65-75 years 35.2 ( ) 15.3 ( ) 38.7 ( ) 4.9 ( ) >75 years 122.2 ( ) 34.2 ( ) 87.3 ( ) 28.2 ( ) Soedamah-Muthu SS, et al. Diabetes Care 2006; 29:798–804. 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, % ACCORD1,4 127/67 2.35 (91) 88 76 ADVANCE2,4 136/74 2.64 (102) 47 56 VADT3,4 127/68 2.07 (80) 84 87 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 Managing cardiovascular risk factors
Patients with T1DM of ≥ 15 years’ duration and aged >30 should be considered at high risk of CVD CDA. Can J Diabetes 2008; 32(Suppl. 1):S1–S201. 38

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

40 Psychological aspects

41 Depressive symptoms significantly related to HbA1c in T1DM
Significant positive relationship between BDI score and HbA1c (r = 0.44, P < 0.02) HbA1c (%) 12 11 10 9 8 7 6 5 10 15 20 Beck Depression Inventory (BDI) score BDI score ≥16 indicates possible clinical depression Reproduced with permission from Van Tilburg MA, et al. Psychosom Med 2001; 63:551–555.

42 Disordered eating behavior associated with higher risk of retinopathy & nephropathy in young women with T1DM Disordered-eating status at baseline Diabetic retinopathy at follow-up* Abnormal urinary albumin excretion at follow-up Highly disordered 86% (6/7) 43% (3/7) Moderately disordered 43% (6/14) 20% (3/15) Nondisordered 24% (12/50) 18% (9/50) Values are % (n with complications/total n) Mean age at baseline (±SD): 15±2 years (range 12–18) Rydall AC, et al. N Engl J Med 1997; 336:1849–1854. Copyright 1997 Massachusetts Medical Society. All rights reserved.

43 Psychological aspects of type 1 diabetes
The Global Partnership recommends: Explore psychological issues associated with type 1 diabetes and treat/refer, as appropriate 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
The Global Partnership recommends: Adopt a multidisciplinary team approach with shared goals and recommendations 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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