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A correction has been published: N Engl J Med 2000;342(18):1376.

Original Article
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Volume 342:381-389 February 10, 2000 Number 6
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Retinopathy and Nephropathy in Patients with Type 1 Diabetes Four Years after a Trial of Intensive Therapy
The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group

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ABSTRACT

Background Among patients with type 1 diabetes mellitus, intensive therapy (with the aim of achieving near-normal blood glucose and glycosylated hemoglobin concentrations) markedly reduces the risk of microvascular complications as compared with conventional therapy. To assess whether these benefits persist, we compared the effects of former intensive and conventional therapy on the occurrence and severity of retinopathy and nephropathy for four years after the end of the Diabetes Control and Complications Trial (DCCT).

Methods At the end of the DCCT, the patients in the conventional-therapy group were offered intensive therapy, and the care of all patients was transferred to their own physicians. Retinopathy was evaluated on the basis of centrally graded fundus photographs in 1208 patients during the fourth year after the DCCT ended, and nephropathy was evaluated on the basis of urine specimens obtained from 1302 patients during the third or fourth year, approximately half of whom were from each treatment group.

Results The difference in the median glycosylated hemoglobin values between the conventional-therapy and intensive-therapy groups during the 6.5 years of the DCCT (average, 9.1 percent and 7.2 percent, respectively) narrowed during follow-up (median during 4 years, 8.2 percent and 7.9 percent, respectively; P<0.001). Nevertheless, the proportion of patients who had worsening retinopathy, including proliferative retinopathy, macular edema, and the need for laser therapy, was lower in the intensive-therapy group than in the conventional-therapy group (odds reduction, 72 percent to 87 percent; P<0.001). The proportion of patients with an increase in urinary albumin excretion was significantly lower in the intensive-therapy group.

Conclusions The reduction in the risk of progressive retinopathy and nephropathy resulting from intensive therapy in patients with type 1 diabetes persists for at least four years, despite increasing hyperglycemia.


Source Information

The writing group (John M. Lachin, Sc.D., Saul Genuth, M.D., Patricia Cleary, M.S., Matthew D. Davis, M.D., and David M. Nathan, M.D.) assumes responsibility for the overall content and integrity of the manuscript. Other members of the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group are listed in the Appendix.

Address reprint requests to the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group, Box NDIC/EDIC, Bethesda, MD 20892, or at nathan{at}gcrc.mgh. harvard.edu.

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