Threshold-Based Insulin-Pump Interruption for Reduction of Hypoglycemia
Threshold-Based Insulin-Pump Interruption for Reduction of Hypoglycemia
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DOI：
10.1056/nejmoa1303576
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发表时间：
2013-07-18
影响因子：
158.5
通讯作者：
Kaufman, Francine R.
中科院分区：
文献类型：
--
作者：
Bergenstal, Richard M.;Klonoff, David C.;Kaufman, Francine R.
背景传感器增强胰岛素泵的阈值暂停特征被设计为通过在预设的传感器葡萄糖值处中断胰岛素输送来最小化低血糖症的风险。我们评估了传感器增强胰岛素泵治疗与无阈值暂停功能的患者夜间hypoglycaemia.MethodsWe随机分配患者1型糖尿病和记录夜间低血糖接受传感器增强胰岛素泵治疗与或无阈值暂停功能3个月。主要安全性结局是糖化血红蛋白水平的变化。主要疗效结局为夜间低血糖事件的曲线下面积（AUC）。两个小时的阈值暂停事件进行了分析相对于随后的传感器glucose values.ResultsA共247例患者被随机分配到接受传感器增强胰岛素泵治疗的阈值暂停功能（阈值暂停组，121例）或标准传感器增强胰岛素泵治疗（对照组，126例）。两组糖化血红蛋白值的变化相似。阈值暂停组夜间低血糖事件的平均AUC比对照组低37.5%（980 +/- 1200 mg/dl [54.4 +/- 66.6 mmol/l] x分钟vs. 1568 +/- 1995 mg/dl [87.0 +/- 110.7 mmol/l] x分钟，P
BackgroundThe threshold-suspend feature of sensor-augmented insulin pumps is designed to minimize the risk of hypoglycemia by interrupting insulin delivery at a preset sensor glucose value. We evaluated sensor-augmented insulin-pump therapy with and without the threshold-suspend feature in patients with nocturnal hypoglycemia.MethodsWe randomly assigned patients with type 1 diabetes and documented nocturnal hypoglycemia to receive sensor-augmented insulin-pump therapy with or without the threshold-suspend feature for 3 months. The primary safety outcome was the change in the glycated hemoglobin level. The primary efficacy outcome was the area under the curve (AUC) for nocturnal hypoglycemic events. Two-hour threshold-suspend events were analyzed with respect to subsequent sensor glucose values.ResultsA total of 247 patients were randomly assigned to receive sensor-augmented insulin-pump therapy with the threshold-suspend feature (threshold-suspend group, 121 patients) or standard sensor-augmented insulin-pump therapy (control group, 126 patients). The changes in glycated hemoglobin values were similar in the two groups. The mean AUC for nocturnal hypoglycemic events was 37.5% lower in the threshold-suspend group than in the control group (980 +/- 1200 mg per deciliter [54.4 +/- 66.6 mmol per liter]xminutes vs. 1568 +/- 1995 mg per deciliter [87.0 +/- 110.7 mmol per liter]xminutes, P