Background Among patients with type 1 diabetes mellitus, intensivetherapy (with the aim of achieving near-normal blood glucoseand glycosylated hemoglobin concentrations) markedly reducesthe risk of microvascular complications as compared with conventionaltherapy. To assess whether these benefits persist, we comparedthe effects of former intensive and conventional therapy onthe occurrence and severity of retinopathy and nephropathy forfour years after the end of the Diabetes Control and ComplicationsTrial (DCCT).
Methods At the end of the DCCT, the patients in the conventional-therapygroup were offered intensive therapy, and the care of all patientswas transferred to their own physicians. Retinopathy was evaluatedon the basis of centrally graded fundus photographs in 1208patients during the fourth year after the DCCT ended, and nephropathywas evaluated on the basis of urine specimens obtained from1302 patients during the third or fourth year, approximatelyhalf of whom were from each treatment group.
Results The difference in the median glycosylated hemoglobinvalues between the conventional-therapy and intensive-therapygroups during the 6.5 years of the DCCT (average, 9.1 percentand 7.2 percent, respectively) narrowed during follow-up (medianduring 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 theneed for laser therapy, was lower in the intensive-therapy groupthan in the conventional-therapy group (odds reduction, 72 percentto 87 percent; P<0.001). The proportion of patients withan increase in urinary albumin excretion was significantly lowerin the intensive-therapy group.
Conclusions The reduction in the risk of progressive retinopathyand nephropathy resulting from intensive therapy in patientswith type 1 diabetes persists for at least four years, despiteincreasing 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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A correction has been published: N Engl J Med 2000;342(18):1376.
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