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NATURAL HISTORY OF TYPE 1 DIABETES: EFFECT OF INTENSIVE MANAGEMENT – RETINOTHERAPY – THE DESIGN OF THE DCCT

The design of the DCCT included a group of recently diagnosed type 1 diabetics with disease duration of 1-5 years and no retinopathy to explore the primary prevention of retinopathy (n = 726 patients). A second group had diabetes of up to 15 years’ duration and only background retinopathy (n = 715 patients). This group afforded the opportunity to study the effect of glycemic control on existing mild retinopathy—a secondary prevention trial.The patients were followed for a mean of 6.5 years (range: 3-9 years), and the appearance of retinopathy was assessed by stereophotographs read by masked observers at a central laboratory. Retinopathy was graded according to a precisely defined 25-step scale. Thus, the primary endpointof the study was objective, unbiased, precise, and clinically significant. Progression of retinopathy in the group assigned to standard therapy was compared with progression in patients treated with intensive glycemic control, and* results in the primary and secondary prevention strata were analyzed separately. The median HbA1c in the conventional group was 9.02% and the median HbA1 c in the intensively treated group was 7.07% at the final visit, demonstrating a clinically significant difference in long-term glycemic control between the two groups.*25\357\8*

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