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Diabetes Control and Complications Trial (DCCT)

NCT00360815 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1441

Last updated 2010-03-02

No results posted yet for this study

Summary

Background. 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.

Methods. 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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

BEHAVIORAL

Insulin

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Oscar B. Crofford, M.D. · Vanderbilt University

  • Carolyn Siebert, M.P.H. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  • Patricia A. Cleary, M.S. · George Washington University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1983-08-31
Completion
1993-04-30

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00360815 on ClinicalTrials.gov