Diabetes Control and Complications Trial (DCCT)
- Conditions
- Type 1 Diabetes Mellitus
- Registration Number
- NCT00360815
- 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (38)
University of Maryland
🇺🇸Baltimore, Maryland, United States
International Diabetes Center
🇺🇸Minneapolis, Minnesota, United States
DCCT Central Nutrition Coding Unit
🇺🇸Minneapolis, Minnesota, United States
DCCT Central Biochemistry Laboratory
🇺🇸Minneapolis, Minnesota, United States
University of Washington
🇺🇸Seattle, Washington, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Washington University at St. Louis
🇺🇸St. Louis, Missouri, United States
DCCT Central Neurobehavioral Coding Unit
🇺🇸Pittsburgh, Pennsylvania, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
George Washington University, Biostatistics Center
🇺🇸Rockville, Maryland, United States
Mayo Foundation
🇺🇸Rochester, Minnesota, United States
University of Missouri
🇺🇸Columbia, Missouri, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Joslin Diabetes Center, Inc.
🇺🇸Boston, Massachusetts, United States
Case Western Reserve University, Lakeside Hospital
🇺🇸Cleveland, Ohio, United States
DCCT Central Autonomic Coding Unit
🇺🇸Springfield, Illinois, United States
Backup DCCT Central HbA1c Lab
🇺🇸Columbia, Missouri, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Michigan, Sattelite-Henry Ford Hospital
🇺🇸Ann Arbor, Michigan, United States
University of Pittsburgh, Children's Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Cornell University Medical College, The New York Hospital
🇺🇸New York, New York, United States
University of Texas
🇺🇸Dallas, Texas, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
DCCT Central Ophthalmologic Reading Unit, Fundus Photo Reading Center
🇺🇸Madison, Wisconsin, United States
University of Washington (British Columbia Satellite)
🇨🇦Vancouver, British Columbia, Canada
University of Toronto, Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
University of Western Ontario
🇨🇦London, Ontario, Canada
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
University of California
🇺🇸La Jolla, California, United States
University of South Florida College of Medicine
🇺🇸Tampa, Florida, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
DCCT Central ECG Reading Unit
🇺🇸Minneapolis, Minnesota, United States
University of New Mexico School of Medicine
🇺🇸Albuquerque, New Mexico, United States
Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
University of Pennsylvania, The Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Tennessee
🇺🇸Memphis, Tennessee, United States
Vanderbilt University, Diabetes Research and Training Center
🇺🇸Nashville, Tennessee, United States