Type 1 Diabetes Mellitus Clinical Trial
Official title:
Diabetes Control and Complications Trial (DCCT)
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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