Diabetes Control and Complications Trial - Methods

Methods

A total of 1,441 volunteers with type 1 diabetes were recruited from 29 medical centers in the United States and Canada between 1983 and 1989, and were followed up until 1993. Each were randomly assigned to receive standard therapy or intensive control therapy. Patients with type 2 diabetes were excluded from the study, as were those who had been diagnosed less than one year ago or more than 15 years before.

Of those studied, 726 had no retinopathy at the beginning of the trial, and 715 had limited retinopathy. Those with greater degrees of retinopathy were excluded from the trial.

The volunteers were randomly assigned to one of two groups. The conventional diabetes therapy group received one or two daily insulin injections. The intensive therapy group frequently monitored blood glucose levels and received at least three daily insulin injections; a few wore an external pump.

Patients in the study were followed for an average of 6.5 years. The appearance and progression of retinopathy and certain other complications were regularly assessed.

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