Diabetes Care. 1995 Mar;18(3):361-76. doi: 10.2337/diacare.18.3.361.
To describe the methods used to implement intensive and conventional therapies in the Diabetes Control and Complications Trial (DCCT) and the metabolic results that occurred with the different treatment regimens.
The DCCT was a controlled clinical trial that demonstrated the beneficial effect of intensive therapy on the long-term complications of insulin-dependent diabetes mellitus (IDDM). A total of 1,441 volunteers with IDDM, aged 13-39, from 29 centers in the U.S. and Canada, were randomly assigned to conventional or intensive diabetes therapy. Intensive therapy, which used multiple daily injections (MDI) of insulin ( > or = 3 injections/day) or continuous subcutaneous insulin infusion (CSII), was implemented by a team that included diabetes nurses, dietitians, behavioral experts, and diabetologists. Volunteers in the intensive treatment group could use MDI or CSII, based on patient and clinic preference, and could switch between therapies over the course of the study. The volunteers were followed for a mean of 6.5 years (range 3-9 years).
A detailed analysis of implementation of the two treatments indicates that intensive and conventional treatment subjects adhered to their respective insulin injection regimens > 97% of the time. Adherence to other elements of intensive treatment was similarly high and resulted in median HbA1c values between 6.7 and 7.2, compared with 8.7-9.2 with conventional therapy, over the course of the study. Severe hypoglycemia occurred three times more often in intensively treated subjects. Although subjects on intensive treatment were not randomly assigned to MDI or CSII, we compared those subjects who used either of these methods for > or = 90% of the study time. CSII-treated patients maintained a mean HbA1c of 6.8 vs. 7.0 in MDI-treated subjects during the trial (P < 0.05). The frequency of hypoglycemia with coma and seizure and diabetic ketoacidosis was modestly higher with CSII than with MDI.
Intensive therapy was implemented successfully in the DCCT. The detailed description herein will serve to facilitate translation of the DCCT results to the clinical setting.
描述在糖尿病控制与并发症试验（DCCT）中实施强化治疗和常规治疗的方法，以及不同治疗方案所产生的代谢结果。
DCCT是一项对照临床试验，证明了强化治疗对胰岛素依赖型糖尿病（IDDM）长期并发症的有益作用。来自美国和加拿大29个中心的1441名年龄在13 - 39岁的IDDM志愿者被随机分配接受常规或强化糖尿病治疗。强化治疗采用每日多次注射（MDI）胰岛素（≥3次/天）或持续皮下胰岛素输注（CSII），由包括糖尿病护士、营养师、行为专家和糖尿病专家的团队实施。强化治疗组的志愿者可根据患者和诊所的偏好使用MDI或CSII，并可在研究过程中在两种治疗方法之间切换。志愿者平均随访6.5年（范围3 - 9年）。
对两种治疗实施情况的详细分析表明，强化治疗和常规治疗的受试者在超过97%的时间里坚持各自的胰岛素注射方案。对强化治疗其他要素的依从性同样很高，在研究过程中，强化治疗组的糖化血红蛋白（HbA1c）中位数在6.7至7.2之间，而常规治疗组为8.7 - 9.2。强化治疗的受试者严重低血糖发生率高出三倍。尽管强化治疗的受试者并非随机分配接受MDI或CSII，但我们比较了那些在研究时间的≥90%使用这两种方法之一的受试者。在试验期间，接受CSII治疗的患者平均HbA1c为6.8，而接受MDI治疗的受试者为7.0（P < 0.05）。CSII治疗导致昏迷、癫痫发作和糖尿病酮症酸中毒的低血糖发生率略高于MDI。
DCCT成功实施了强化治疗。本文的详细描述将有助于把DCCT的结果转化应用于临床。
