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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00360815 |
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 |
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Type 1 Diabetes Mellitus |
Behavioral: Insulin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Diabetes Control and Complications Trial (DCCT) |
Ages Eligible for Study: | 13 Years to 39 Years |
Genders Eligible for Study: | Both |
Eligibility Criteria:
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 |
Study ID Numbers: | N01-DK-6-2204-A |
Study First Received: | August 2, 2006 |
Last Updated: | August 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00360815 |
Health Authority: | United States: Federal Government |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Immune System Diseases |