The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus

D M Nathan; S Genuth; J Lachin; P Cleary; O Crofford; M Davis; L Rand; C Siebert; Diabetes Control and Complications Trial Research Group

doi:10.1056/NEJM199309303291401

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The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus

Journal article

Open access

Peer reviewed

The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus

D M Nathan, S Genuth, J Lachin, P Cleary, O Crofford, M Davis, L Rand, C Siebert and Diabetes Control and Complications Trial Research Group

The New England journal of medicine, Vol.329(14), pp.977-986

09/30/1993

DOI: 10.1056/NEJM199309303291401

PMID: 8366922

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Abstract

Long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus (IDDM). We examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications. A total of 1441 patients with IDDM--726 with no retinopathy at base line (the primary-prevention cohort) and 715 with mild retinopathy (the secondary-intervention cohort) were randomly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections. The patients were followed for a mean of 6.5 years, and the appearance and progression of retinopathy and other complications were assessed regularly. In the primary-prevention cohort, intensive therapy reduced the adjusted mean risk for the development of retinopathy by 76 percent (95 percent confidence interval, 62 to 85 percent), as compared with conventional therapy. In the secondary-intervention cohort, intensive therapy slowed the progression of retinopathy by 54 percent (95 percent confidence interval, 39 to 66 percent) and reduced the development of proliferative or severe nonproliferative retinopathy by 47 percent (95 percent confidence interval, 14 to 67 percent). In the two cohorts combined, intensive therapy reduced the occurrence of microalbuminuria (urinary albumin excretion of > or = 40 mg per 24 hours) by 39 percent (95 percent confidence interval, 21 to 52 percent), that of albuminuria (urinary albumin excretion of > or = 300 mg per 24 hours) by 54 percent (95 percent confidence interval 19 to 74 percent), and that of clinical neuropathy by 60 percent (95 percent confidence interval, 38 to 74 percent). The chief adverse event associated with intensive therapy was a two-to-threefold increase in severe hypoglycemia. Intensive therapy effectively delays the onset and slows the progression of diabetic retinopathy, nephropathy, and neuropathy in patients with IDDM.

Confidence Intervals

Blood Glucose - analysis

Diabetic Neuropathies - prevention & control

Follow-Up Studies

Humans

Insulin - administration & dosage

Male

Treatment Outcome

Diabetes Mellitus, Type 1 - complications

Diabetes Mellitus, Type 1 - drug therapy

Diabetic Retinopathy - prevention & control

Diabetes Mellitus, Type 1 - blood

Adolescent

Adult

Female

Insulin Infusion Systems

Diabetic Nephropathies - prevention & control

Insulin - adverse effects

Insulin - therapeutic use

Details

Title: Subtitle: The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus
Creators: D M Nathan
S Genuth
J Lachin
P Cleary
O Crofford
M Davis
L Rand
C Siebert
Diabetes Control and Complications Trial Research Group
Contributors: Rodney R Zeitler (Contributor) - University of Iowa, Internal Medicine
Resource Type: Journal article
Publication Details: The New England journal of medicine, Vol.329(14), pp.977-986
DOI: 10.1056/NEJM199309303291401
PMID: 8366922
NLM abbreviation: N Engl J Med
ISSN: 0028-4793
eISSN: 1533-4406
Language: English
Date published: 09/30/1993
Academic Unit: General Internal Medicine; Internal Medicine
Record Identifier: 9984094382002771

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