Diabetes Care. 1990 Apr;13(4):427-33. doi: 10.2337/diacare.13.4.427.
The Diabetes Control and Complications Trial (DCCT) is a prospective randomized multicenter clinical trial to compare the effects of intensive insulin therapy aimed at near normalization of blood glucose levels with the effects of conventional therapy on the early microvascular complications of insulin-dependent diabetes mellitus. With the successful completion of its planning and feasibility phases, the DCCT is currently conducting the full-scale long-term trial. The total study cohort (n = 1441) has been recruited and randomized to either intensive or standard therapy. The range of follow-up for all subjects will be 5-10 yr, with a median of 7 yr at the trial's end in 1993. Adherence to the study protocol and prescribed regimens remains excellent. Glycemic separation between the randomized treatments, demonstrated during the 1-yr feasibility phase, remains over the first 3 yr of the study. This update reviews the rationale and design of the DCCT, changes in the protocol since its inception, study progress to date, including baseline characteristics of the entire study population, and the results of analyses of baseline data.
糖尿病控制与并发症试验（DCCT）是一项前瞻性随机多中心临床试验，旨在比较旨在使血糖水平接近正常化的强化胰岛素治疗与传统治疗对胰岛素依赖型糖尿病早期微血管并发症的影响。随着其规划和可行性阶段的成功完成，DCCT目前正在进行全面的长期试验。已招募了全部研究队列（n = 1441）并将其随机分为强化治疗组或标准治疗组。所有受试者的随访时间为5至10年，到1993年试验结束时中位数为7年。对研究方案和规定治疗方案的依从性仍然很好。在1年可行性阶段所显示的随机治疗之间的血糖差异在研究的前3年中仍然存在。本更新内容回顾了DCCT的基本原理和设计、自开始以来方案的变化、迄今为止的研究进展，包括整个研究人群的基线特征，以及基线数据分析结果。
