Am J Med. 1991 Apr;90(4):450-9.
The present study describes the epidemiology of severe hypoglycemia and identifies patient characteristics or behaviors associated with severe hypoglycemia in patients with insulin-dependent diabetes mellitus (IDDM) participating in the Diabetes Control and Complications Trial (DCCT).
The DCCT is a multicenter randomized clinical trial designed to compare the benefits and risks of intensive therapy with those of conventional management of IDDM. The DCCT's feasibility phase demonstrated that intensive therapy, with the aim of achieving glucose levels as close to the non-diabetic range as possible, was accompanied by a threefold increase in severe hypoglycemia compared with conventional therapy. This report is based on the first 817 subjects who entered the DCCT, with a mean follow-up of 21 months.
Two hundred sixteen subjects reported 714 episodes of severe hypoglycemia; 549 (77%) occurred in intensively treated subjects. The incidence of severe hypoglycemia in the intensive treatment group ranged from two to six times that observed with conventional treatment. Severe hypoglycemia occurred more often during sleep (55%); 43% of all episodes occurred between midnight and 8 AM. Of episodes that occurred while subjects were awake, 36% were not accompanied by warning symptoms. In intensively treated subjects, predictors of severe hypoglycemia included history of severe hypoglycemia, longer duration of IDDM, higher baseline glycosylated hemoglobin (HbA1c) levels, and a lower recent HbA1c. Multivariate analyses failed to yield predictive models with high sensitivity.
In the DCCT, intensive treatment of IDDM increased the frequency of severe hypoglycemia relative to conventional therapy. Intensive treatment may cause even more frequent severe hypoglycemia when applied to less selected and less motivated populations in the clinical practice setting. These findings underscore the importance of determining the benefit-risk ratio of intensive and standard therapy of IDDM.
本研究描述了严重低血糖的流行病学情况，并确定了参与糖尿病控制与并发症试验（DCCT）的胰岛素依赖型糖尿病（IDDM）患者中与严重低血糖相关的患者特征或行为。
DCCT是一项多中心随机临床试验，旨在比较强化治疗与IDDM传统管理的益处和风险。DCCT的可行性阶段表明，旨在使血糖水平尽可能接近非糖尿病范围的强化治疗，与传统治疗相比，严重低血糖的发生率增加了两倍。本报告基于最初进入DCCT的817名受试者，平均随访21个月。
216名受试者报告了714次严重低血糖发作；549次（77%）发生在接受强化治疗的受试者中。强化治疗组严重低血糖的发生率是传统治疗组观察到的发生率的两到六倍。严重低血糖在睡眠期间更常发生（55%）；所有发作的43%发生在午夜至上午8点之间。在受试者清醒时发生的发作中，36%没有伴随警告症状。在接受强化治疗的受试者中，严重低血糖的预测因素包括严重低血糖病史、IDDM病程较长、基线糖化血红蛋白（HbA1c）水平较高以及近期HbA1c较低。多变量分析未能产生具有高敏感性的预测模型。
在DCCT中，IDDM的强化治疗相对于传统治疗增加了严重低血糖的发生频率。在临床实践环境中，当强化治疗应用于选择较少且积极性较低的人群时，可能会导致更频繁的严重低血糖。这些发现强调了确定IDDM强化治疗和标准治疗的效益风险比的重要性。
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