Diabetes Control and Complications Trial (DCCT)

March 1, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1441

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3N9
        • University of Washington (British Columbia Satellite)
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • University of Western Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • University of Toronto, Mount Sinai Hospital
  • United States
    • California
      • La Jolla, California, United States, 92093-0620
        • University of California
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine
    • Florida
      • Tampa, Florida, United States, 33612
        • University of South Florida College of Medicine
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Springfield, Illinois, United States, 62702
        • DCCT Central Autonomic Coding Unit
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
      • Rockville, Maryland, United States, 20852
        • George Washington University, Biostatistics Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center, Inc.
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0832
        • University of Michigan, Sattelite-Henry Ford Hospital
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • International Diabetes Center
      • Minneapolis, Minnesota, United States, 55454-1015
        • DCCT Central Nutrition Coding Unit
      • Minneapolis, Minnesota, United States, 55455-1015
        • DCCT Central ECG Reading Unit
      • Minneapolis, Minnesota, United States, 55455-9980
        • DCCT Central Biochemistry Laboratory
      • Rochester, Minnesota, United States, 55905
        • Mayo Foundation
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri
      • Columbia, Missouri, United States, 65201
        • Backup DCCT Central HbA1c Lab
      • St. Louis, Missouri, United States, 63110
        • Washington University at St. Louis
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico School of Medicine
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein College of Medicine
      • New York, New York, United States, 10021
        • Cornell University Medical College, The New York Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University, Lakeside Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania, The Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15213-3417
        • University of Pittsburgh, Children's Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • DCCT Central Neurobehavioral Coding Unit
    • South Carolina
      • Charleston, South Carolina, United States, 29403-5851
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University, Diabetes Research and Training Center
      • Nashville, Tennessee, United States, 37232-2230
        • Vanderbilt University
    • Texas
      • Dallas, Texas, United States, 75235
        • University of Texas
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington
    • Wisconsin
      • Madison, Wisconsin, United States, 53705-0240
        • DCCT Central Ophthalmologic Reading Unit, Fundus Photo Reading Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 39 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Chair: Oscar B. Crofford, M.D., Vanderbilt University
  • Study Director: Carolyn Siebert, M.P.H., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Principal Investigator: Patricia A. Cleary, M.S., George Washington University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1983

Study Completion

April 1, 1993

Study Registration Dates

First Submitted

August 2, 2006

First Submitted That Met QC Criteria

August 4, 2006

First Posted (Estimate)

August 7, 2006

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

March 1, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N01-DK-6-2204-A (completed)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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