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Cited by 331

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The Diabetes Control and Complications Trial (DCCT): Design and Methodologic Considerations for the Feasibility Phase

The DCCT Research Group·1986·Diabetes
DOI 10.2337/diab.35.5.530
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Abstract

The Diabetes Control and Complications Trial (DCCT) is a randomized, controlled clinical trial designed to assess the'relationship between glycemic control and the development, progression, or amelioration of early vascular complications in persons with insulin-dependent diabetes mellitus (IDDM). The DCCT consists of two parallel studies: a primary prevention study and a secondary intervention study. The principal outcome in the primary prevention study is the initial appearance and subsequent progression of background retinopathy. In the secondary intervention study, the principal outcome is the progression or amelioration of preexistent minimal retinopathy. Subjects are randomly assigned to receive either experimental or standard therapy. Experimental therapy involves the use of an intensive insulin regimen designed to maintain near-normal glycemic levels in the absence of severe hypoglycemia. Standard treatment is designed to maintain subjects free of clinical symptoms related to hyper- or hypoglycemia while receiving up to two insulin injections daily. Two hundred seventy-eight volunteers have been enrolled in 21 centers in the United States and Canada in a preliminary study to assess the feasibility of conducting a full-scale, long-term clinical trial. Based on an external review of the feasibility study results, the DCCT will be expanded to include over 1400 subjects treated for a period of up to 10 yr. This article describes the DCCT and the considerations that led to the choice of specific design features for the feasibility phase.

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Metadata

Authors
The DCCT Research Group
Venue
Diabetes
Publisher
American Diabetes Association
Published
1986-05-01
Volume
35
Issue
5
Pages
530-545
ISSN
  • 0012-1797 (ISSN-L)
  • 1939-327X
DOI
10.2337/diab.35.5.530
OpenAlex
W4234917751
Cited by
331
References
0
FWCI
7.20
Type
journal article
Language
en
Open access
closed

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