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Abstract OBJECTIVE: To examine the effect of intensive therapy on neuropsychological performance in patients who participated in the Diabetes Control and Complications Trial (DCCT). DESIGN: Multicenter, randomized, controlled clinical trial. SETTING: 29 DCCT clinical centers. PATIENTS: 1441 patients with insulin-dependent diabetes mellitus (IDDM) between 13 and 39 years of age who had had IDDM for 1 to 15 years and had no or minimal retinopathy or nephropathy at baseline. Volunteers were excluded if they had a history of substance abuse, psychological disturbance, or recurrent hypoglycemia with coma or seizure. INTERVENTION: Intensive therapy with 3 or more daily insulin injections or continuous subcutaneous insulin infusion, guided by 4 or more glucose tests per day, compared with conventional therapy with 1 or 2 daily insulin injections. OUTCOME MEASURES: Neuropsychological assessments were done at baseline; years 2, 5, and 7; and the end of the study. Eight cognitive domain scores were developed from the test results and were used to identify patients whose neuropsychological performance had clinically worsened. RESULTS: Intensive therapy did not affect neuropsychological performance. In addition, patients who had repeated episodes of hypoglycemia did not perform differently than patients who did not have repeated episodes. CONCLUSION: Intensive therapy and the attendant risk for hypoglycemia were not associated with neuropsychological impairment in the DCCT.
This article was published in Ann Intern Med
and referenced in Journal of Diabetes & Metabolism