Diabetes Control and Complications Trial (DCCT)

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Diabetes Control and Complications Trial (DCCT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360815
• Other study ID #: N01-DK-6-2204-A (completed)
• Status: Completed
• Phase: N/A
• First received: August 2, 2006
• Last updated: March 1, 2010
• Start date: August 1983
• Est. completion date: April 1993

Study information

• Verified date: March 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1441
• Est. completion date: April 1993
• Gender: Both
• Age group: 13 Years to 39 Years

Eligibility

Eligibility Criteria:

• The major criteria for eligibility included insulin dependence, as evidenced by deficient C-peptide secretion; an age of 13 to 39 years; and the absence of hypertension, hypercholesterolemia, and severe diabetic complications or medical conditions. To be eligible for the primary-prevention cohort, patients were required to have had insulin dependent diabetes mellitus (IDDM) for one to five years, to have no retinopathy as detected by seven-field stereoscopic fundus photography, and to have urinary albumin excretion of less than 40 mg per 24 hours. To be eligible for the secondary-intervention cohort, the patients were required to have IDDM for 1 to 15 years, to have very-mild to moderate nonproliferative retinopathy, and to have urinary albumin excretion of less than 200 mg per 24 hours.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• Insulin

Locations

Country	Name	City	State
Canada	University of Western Ontario	London	Ontario
Canada	University of Toronto, Mount Sinai Hospital	Toronto	Ontario
Canada	University of Washington (British Columbia Satellite)	Vancouver	British Columbia
United States	University of New Mexico School of Medicine	Albuquerque	New Mexico
United States	University of Michigan, Sattelite-Henry Ford Hospital	Ann Arbor	Michigan
United States	University of Maryland	Baltimore	Maryland
United States	Joslin Diabetes Center, Inc.	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Albert Einstein College of Medicine	Bronx	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	Case Western Reserve University, Lakeside Hospital	Cleveland	Ohio
United States	Backup DCCT Central HbA1c Lab	Columbia	Missouri
United States	University of Missouri	Columbia	Missouri
United States	University of Texas	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	University of Iowa	Iowa City	Iowa
United States	University of California	La Jolla	California
United States	DCCT Central Ophthalmologic Reading Unit, Fundus Photo Reading Center	Madison	Wisconsin
United States	University of Tennessee	Memphis	Tennessee
United States	DCCT Central Biochemistry Laboratory	Minneapolis	Minnesota
United States	DCCT Central ECG Reading Unit	Minneapolis	Minnesota
United States	DCCT Central Nutrition Coding Unit	Minneapolis	Minnesota
United States	International Diabetes Center	Minneapolis	Minnesota
United States	University of Minnesota	Minneapolis	Minnesota
United States	Vanderbilt University	Nashville	Tennessee
United States	Vanderbilt University, Diabetes Research and Training Center	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Cornell University Medical College, The New York Hospital	New York	New York
United States	University of Pennsylvania, The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	DCCT Central Neurobehavioral Coding Unit	Pittsburgh	Pennsylvania
United States	University of Pittsburgh, Children's Hospital	Pittsburgh	Pennsylvania
United States	Mayo Foundation	Rochester	Minnesota
United States	George Washington University, Biostatistics Center	Rockville	Maryland
United States	University of Washington	Seattle	Washington
United States	DCCT Central Autonomic Coding Unit	Springfield	Illinois
United States	Washington University at St. Louis	St. Louis	Missouri
United States	University of South Florida College of Medicine	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Countries where clinical trial is conducted

United States,  Canada,