The Laboratory embarked upon the business of research in addition to its clinical responsibilities, with the Diabetes Control and Complications Trial (DCCT) in 1983.
In its report to the Congress in 1975, the National Commission on Diabetes recommended that the National Institute of Arthritis, Metabolism and Digestive Diseases (NIAMDD) and the National Heart, Lung, and Blood Institute (NHLBI) initiate and support a five-year clinical study to assess the effect of treatment of insulin-dependent diabetes mellitus (IDDM) on the development of microvascular and macrovascular complications.
If warranted by the results of the feasibility study, the seven- to ten-year full scale trial would follow, and it did.
In 1977, the NIAMDD and the NHLBI convened an ad hoc committee to consider whether, how, and when such a clinical trial should be initiated. In 1978, that committee issued its report recommending that such an undertaking was both ethical and feasible and that the Institutes should proceed with a phased clinical trial to compare the effects of "strict" versus "conventional" treatment regimens.
Phase II of the DCCT began as a two-year, randomized, controlled, unmasked feasibility study with several objectives. One objective was to determine whether a clinically and statistically significant difference in level of blood glucose control could be achieved between standard and experimental therapy groups as assessed by hemoglobin A1c and blood glucose measurements. A second objective was to determine whether the biochemical and pathologic characteristics of IDDM could be measured and documented with acceptable precision and accuracy.