Severe hypoglycemia during maximized insulin treatment of diabetes in a randomized clinical trial.

Our experience with hypoglycemia during a randomized clinical trial testing the hypothesis of a causal relationship between hyperglycemia and diabetic complications is described. Patients under maximized control experienced hypoglycemia much more often than patients under standard control. There were five episodes of serious hypoglycemia, none of them on pumps, in the former group, but none in the latter. Lack of compliance (or overcompliance) with certain aspects of intensive treatment increases the danger of grave hypoglycemia and should be part of exclusion criteria when considering maximized control.