Publication Description
The Diabetes Control and Complications Trial (1983–1993) of 1,441 subjects followed for an average of 6.5 years assessed the effects of intensive therapy aimed at maintaining near normal levels of blood glucose versus conventional therapy on the risks of diabetes complications of the eyes, kidneys, and nerves. The study was designed to test the hypothesis that the higher than normal blood glucose levels associated with conventional insulin therapy caused these complications. The study was terminated one year ahead of schedule by the monitoring board. This paper describes the medical, ethical, and statistical challenges faced by the study group and the monitoring board.