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Diabetes Control and Complications Trial (DCCT)

Not Applicable
Completed
Conditions
Type 1 Diabetes Mellitus
Registration Number
NCT00360815
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1441
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (38)

University of California

πŸ‡ΊπŸ‡Έ

La Jolla, California, United States

Yale University School of Medicine

πŸ‡ΊπŸ‡Έ

New Haven, Connecticut, United States

University of South Florida College of Medicine

πŸ‡ΊπŸ‡Έ

Tampa, Florida, United States

Northwestern University

πŸ‡ΊπŸ‡Έ

Chicago, Illinois, United States

DCCT Central Autonomic Coding Unit

πŸ‡ΊπŸ‡Έ

Springfield, Illinois, United States

University of Iowa

πŸ‡ΊπŸ‡Έ

Iowa City, Iowa, United States

University of Maryland

πŸ‡ΊπŸ‡Έ

Baltimore, Maryland, United States

George Washington University, Biostatistics Center

πŸ‡ΊπŸ‡Έ

Rockville, Maryland, United States

Massachusetts General Hospital

πŸ‡ΊπŸ‡Έ

Boston, Massachusetts, United States

Joslin Diabetes Center, Inc.

πŸ‡ΊπŸ‡Έ

Boston, Massachusetts, United States

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University of California
πŸ‡ΊπŸ‡ΈLa Jolla, California, United States

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