Background Long-term microvascular and neurologic complicationscause major morbidity and mortality in patients with insulin-dependentdiabetes mellitus (IDDM). We examined whether intensive treatmentwith the goal of maintaining blood glucose concentrations closeto the normal range could decrease the frequency and severityof these complications.
Methods A total of 1441 patients with IDDM -- 726 with no retinopathyat base line (the primary-prevention cohort) and 715 with mildretinopathy (the secondary-intervention cohort) were randomlyassigned to intensive therapy administered either with an externalinsulin pump or by three or more daily insulin injections andguided by frequent blood glucose monitoring or to conventionaltherapy with one or two daily insulin injections. The patientswere followed for a mean of 6.5 years, and the appearance andprogression of retinopathy and other complications were assessedregularly.
Results In the primary-prevention cohort, intensive therapyreduced the adjusted mean risk for the development of retinopathyby 76 percent (95 percent confidence interval, 62 to 85 percent),as compared with conventional therapy. In the secondary-interventioncohort, intensive therapy slowed the progression of retinopathyby 54 percent (95 percent confidence interval, 39 to 66 percent)and reduced the development of proliferative or severe nonproliferativeretinopathy by 47 percent (95 percent confidence interval, 14to 67 percent). In the two cohorts combined, intensive therapyreduced the occurrence of microalbuminuria (urinary albuminexcretion of 40 mg per 24 hours) by 39 percent (95 percentconfidence interval, 21 to 52 percent), that of albuminuria(urinary albumin excretion of 300 mg per 24 hours) by 54 percent(95 percent confidence interval, 19 to 74 percent), and thatof clinical neuropathy by 60 percent (95 percent confidenceinterval, 38 to 74 percent). The chief adverse event associatedwith intensive therapy was a two-to-threefold increase in severehypoglycemia.
Conclusions Intensive therapy effectively delays the onset andslows the progression of diabetic retinopathy, nephropathy,and neuropathy in patients with IDDM.
Source Information
A complete list of the persons and institutions participating in the Diabetes Control and Complications Trial Research Group appears in the Appendix.
Address reprint requests to the DCCT Research Group, Box NDIC/DCCT, Bethesda, MD 20892.
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