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The Diabetes Control and Complications Trial (DCCT). Design and methodologic considerations for the feasibility phase. The DCCT Research Group.
Diabetes. 1986 May; 35(5):530-45.D

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 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.

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

2869996

Citation

"The Diabetes Control and Complications Trial (DCCT). Design and Methodologic Considerations for the Feasibility Phase. the DCCT Research Group." Diabetes, vol. 35, no. 5, 1986, pp. 530-45.
The Diabetes Control and Complications Trial (DCCT). Design and methodologic considerations for the feasibility phase. The DCCT Research Group. Diabetes. 1986;35(5):530-45.
(1986). The Diabetes Control and Complications Trial (DCCT). Design and methodologic considerations for the feasibility phase. The DCCT Research Group. Diabetes, 35(5), 530-45.
The Diabetes Control and Complications Trial (DCCT). Design and Methodologic Considerations for the Feasibility Phase. the DCCT Research Group. Diabetes. 1986;35(5):530-45. PubMed PMID: 2869996.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Diabetes Control and Complications Trial (DCCT). Design and methodologic considerations for the feasibility phase. The DCCT Research Group. PY - 1986/5/1/pubmed PY - 1986/5/1/medline PY - 1986/5/1/entrez SP - 530 EP - 45 JF - Diabetes JO - Diabetes VL - 35 IS - 5 N2 - 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 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. SN - 0012-1797 UR - https://www.unboundmedicine.com/medline/citation/2869996/The_Diabetes_Control_and_Complications_Trial__DCCT___Design_and_methodologic_considerations_for_the_feasibility_phase__The_DCCT_Research_Group_ L2 - https://diabetes.diabetesjournals.org/lookup/pmidlookup?view=long&pmid=2869996 DB - PRIME DP - Unbound Medicine ER -