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Diabetes Control and Complications Trial (DCCT)

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00360815
First received: August 2, 2006
Last updated: March 1, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention
Type 1 Diabetes Mellitus
 Behavioral: Insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Diabetes Control and Complications Trial (DCCT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment: 1441
Study Start Date: August 1983
Estimated Study Completion Date: April 1993
  Eligibility

Ages Eligible for Study:   13 Years to 39 Years
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00360815

  Show 38 Study Locations
Sponsors and Collaborators
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 Institutes of Health, National Institute of Diabetes, and Digestive and Kidney Diseases
Principal Investigator: Patricia A. Cleary, M.S. George Washington University
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00360815     History of Changes
Other Study ID Numbers: N01-DK-6-2204-A (completed)
Study First Received: August 2, 2006
Last Updated: March 1, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 11, 2013