Adverse Events and Their Association With Treatment Regimens in the Diabetes Control and Complications Trial

Abstract

The major adverse effect of intensive therapy of IDDM is a threefold increase in the risk of severe hypoglycemia with potentially serious sequelae. An increased incidence of becoming overweight, the long-term significance of which has yet to be determined, was also observed. Because the results of the DCCT were attained in highly selected, healthy IDDM patients who received attentive clinical management and frequent health education, DCCT adverse event rates may not reflect incidence or prevalence rates that would be expected in nonselected populations or in other clinical settings.