An interventional study of Insulin in Type 1 Diabetes Mellitus, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 38 sites in 2 countries. Open to participants aged 13 Years to 39 Years. Per ClinicalTrials.gov, last updated 2010-03-02.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Not applicable, Interventional, and Treatment
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.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 1,441 is above the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 537 studies on the registry; 54 are open to participants now.
Of its 80 completed or terminated interventional studies of FDA-regulated products, 51 (64%) have results posted.
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