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The major adverse event in the DCCT was a threefold increase in the incidence of severe hypoglycemia in the intensively treated group. Severe hypoglycemia was defined as an episode with symptoms consistent with hypoglycemia, in which the patient required the assistance of another person and which was associated with a blood glucose level <50 mg/dl or prompt recovery after oral carbohydrate, glucagon, or IV glucose. A total of 65% of patients in the intensive group had at least one episode of severe hypoglycemia vs. 35% of patients in the conventional therapy group. Overall rates were 61.2 per 100 years in the intensive group and 18.7 per 100 years in the conventional group. A history of severe hypoglycemia in the past was the best predictor.

Subgroup analyses showed that males, adolescents, and patients with no residual c-peptide secretion had a particularly high rate of severe hypoglycemia in both treatment groups. Intensive treatment was also associated with an increased risk of multiple episodes of severe hypoglycemia within the same patient. Approximately 25-30% of intensively treated patients vs. 5-11 % of the conventional group had severe hypoglycemia year, and about 10-12% vs. 3-5% resulted in a coma or seizure respectively in the two treatment groups. No changes in neuropsychological function were noted.

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