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Effects of Intensive Diabetes Therapy on Neuropsychological Function in Adults in the Diabetes Control and Complications Trial

The Diabetes Control and Complications Trial Research Group*
[+] Article and Author Information

Copyright ©2004 by the American College of Physicians


Ann Intern Med. 1996;124(4):379-388. doi:10.7326/0003-4819-124-4-199602150-00001
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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.

*A complete listing of members of the DCCT Research Group is available in Archives of Ophthalmology, 1995; 113:49-51.

Figures

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Figure 1.
Association between baseline-centered Z scores for motor speed and glycosylated hemoglobin levels.

Each data point represents approximately 100 patients and is indicated by the year of follow-up visit (asterisk, year 2; diamond, year 5; circle, year 7). A spline function was used to fit a smooth line through the data points of each follow-up year in order to indicate the general trend of association in the year of follow-up visit. Data for year 9 contained only three points and were not plotted.

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Grahic Jump Location
Figure 2.
Distribution of the baseline-centered Z scores for problem solving and motor speed at the year 5 visit.

The diamonds represent patients who had more than one coma or seizure events per year up to the fifth year of study; the small dots represent the remaining patients. Twenty-one study patients had values outside of the range of the coordinates; one was patient A, who had had more than one coma or seizure event per year by year 5.

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