1 / 8

DCCT: study design

DCCT: study design. Patients with type 1 diabetes (n = 1441). Secondary intervention (n = 715). Primary prevention (n = 726). Randomise. Randomise. Conventional. Intensive. Conventional. Intensive. DCCT: N Engl J Med 1993;329:977–86. Intensive group (n = 711):

gada
Download Presentation

DCCT: study design

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  1. DCCT: study design Patients with type 1 diabetes (n = 1441) Secondary intervention (n = 715) Primary prevention (n = 726) Randomise Randomise Conventional Intensive Conventional Intensive DCCT: N Engl J Med 1993;329:977–86

  2. Intensive group(n = 711): Aim: symptom-free + plasma glucose 3.9-6.7 mmol/L before meals, < 10 mmol/L after meals, > 4.0 mmol/l at 03.00 a.m. and HbA1c < 6.5%  3 insulin injections / day or insulin pump  4 daily blood glucose tests Hospitalisation for initiation Comprehensive education programme Frequent dietary instructions Monthly clinic visits Conventional group(n = 730): Aim: to avoid symptoms of hyper / hypoglycaemia 1 or 2 insulin injections per day Daily self-monitoring Initial diet and exercise education Quarterly visits DCCT: treatment conditions DCCT: N Engl J Med 1993;329:977–86

  3. Conventional group encouraged to switch to intensive treatment Conventional 11 Intensive 10 9 HbA1c (%) 8 7 6 0 1 2 3 4 5 6 7 8 9 1 2 3 4 5 6 7 DCCT end DCCT EDIC Year DCCT: intensive therapy significantly reduces and maintains HbA1c Adapted from: N Engl J Med 1993;329:977–86, EDIC: JAMA 2002287:2563–9

  4. Intensive 60 30 Conventional 40 20 20 10 0 0 0 2 4 6 8 10 0 2 4 6 8 10 DCCT: intensive therapy reduces microvascular complications Retinopathy: 76% reduction Microalbuminuria*: 34% reduction Patients (%) Patients (%) Years *urinary albumin excretion ≥40 mg per 24 hours Adapted from: N Engl J Med 1993;329:977–86

  5. Risk of developing microalbuminuria Risk of retinopathy progression 16 16 12 12 Rate per 100 patient years Rate per 100 patient years 8 8 4 4 0 0 0 5 6 7 8 9 10 11 12 0 5 6 7 8 9 10 11 12 DCCT: microvascular complications increase as HbA1c increases HbA1c (%) DCCT: N Engl J Med 1993;329:977–86

  6. 0.4 DCCT Intensive DCCT Conventional 0.3 0.2 0.1 0 1 2 3 4 5 6 7 DCCT end Years of follow-up (EDIC) Retinopathy 7 years after the DCCT Cumulative incidence of retinopathy progression Adapted from: JAMA 2002287:2563–9

  7. 12 120 severe hypoglycaemia 10 8 6 60 risk of retinopathy 4 2 0 0 5.5 6 6.5 7 7.5 8 8.5 9 9.5 10 10.5 0 HbA1c (%) DCCT: the price of improved diabetic control – hypoglycaemia Rate pf progression of retinopathy (per 100 patient years) Rate of severe hypoglycaemia (per 100 patient years) Adapted from: N Engl J Med 1993;329:977–86

  8. Economic analysis - DCCT • “From a health care system perspective, intensive therapy represents a good monetary value for the investment”1 • “Although intensive therapy is expensive, when the costs of complications are factored in, it becomes cost-effective for the treatment of type 1 diabetes”2 1. DCCT Research Group. JAMA 1996;276:1409-15 2. Herman WH, Eastman RC. Diabetes Care 1998;21(suppl 3):C19-24

More Related