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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.
Age
13 - 39 years
Sex
ALL
Healthy Volunteers
No
University of California
La Jolla, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
University of South Florida College of Medicine
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
DCCT Central Autonomic Coding Unit
Springfield, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Maryland
Baltimore, Maryland, United States
George Washington University, Biostatistics Center
Rockville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Joslin Diabetes Center, Inc.
Boston, Massachusetts, United States
Start Date
August 1, 1983
Completion Date
April 1, 1993
Last Updated
March 2, 2010
1,441
Estimated participants
Insulin
BEHAVIORAL
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NCT07051005
NCT06390371
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03228732