Diabetes Control and Complications Trial (DCCT)
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|ClinicalTrials.gov Identifier: NCT00360815|
Recruitment Status : Completed
First Posted : August 7, 2006
Last Update Posted : March 2, 2010
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 or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Behavioral: Insulin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1441 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diabetes Control and Complications Trial (DCCT)|
|Study Start Date :||August 1983|
|Study Completion Date :||April 1993|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00360815
|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|