OBJECTIVE:Identify factors predictive of severe hypoglycemia (SH) and assess the clinical utility of continuous glucose monitoring (CGM) to warn of impending SH. RESEARCH DESIGN AND METHODS:In a multicenter randomized clinical trial, 436 children and adults with type 1 diabetes were randomized to a treatment group that used CGM (N = 224), or a control group that used standard home blood glucose monitoring (N = 212) and completed 12 months of follow-up. After 6 months, the original control group initiated CGM while the treatment group continued use of CGM for 6 months. Baseline risk factors for SH were evaluated over 12 months of follow-up using proportional hazards regression. CGM-derived indices of hypoglycemia were used to predict episodes of SH over a 24-h time horizon. RESULTS:The SH rate was 17.9 per 100 person-years, and a higher rate was associated with the occurrence of SH in the prior 6 months and female sex. SH frequency increased eightfold when 30% of CGM values were ≤ 70 mg/dL on the prior day (4.5 vs. 0.5%; P < 0.001), but the positive predictive value (PPV) was low (<5%). Results were similar for hypoglycemic area under the curve and the low blood glucose index calculated by CGM. CONCLUSIONS:SH in the 6 months prior to the study was the strongest predictor of SH during the study. CGM-measured hypoglycemia over a 24-h span is highly associated with SH the following day (P < 0.001), but the PPV is low.

译文

目的:确定可预测严重低血糖(SH)的因素,并评估连续血糖监测(CGM)来警告即将发生的SH的临床实用性。
研究设计和方法:在一项多中心随机临床试验中,将436名1型糖尿病儿童和成人随机分为使用CGM(N = 224)的治疗组或使用标准家庭血糖监测(N = 212)的对照组。 ),并完成了12个月的随访。 6个月后,原始对照组开始CGM,而治疗组继续使用CGM 6个月。在12个月的随访中,使用比例风险回归对SH的基线危险因素进行了评估。 CGM衍生的低血糖指数用于预测24小时内的SH发作。
结果:SH的发生率为每100人年17.9,而较高的发生率与前6个月的SH发生以及女性有关。前一天,当CGM值的30%≤70 mg / dL时,SH频率增加了八倍(4.5对0.5%; P <0.001),但阳性预测值(PPV)低(<5%)。曲线下的降血糖面积和CGM计算的低血糖指数的结果相似。
结论:研究前6个月的SH是研究期间SH的最强预测因子。 CGM在24小时内测量的低血糖与第二天的SH高度相关(P <0.001),但PPV较低。

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