A Randomized Trial of a Home System to Reduce Nocturnal Hypoglycemia in Type 1 Diabetes
A Randomized Trial of a Home System to Reduce Nocturnal Hypoglycemia in Type 1 Diabetes
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DOI：
10.2337/dc13-2159
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发表时间：
2014-07-01
期刊：
影响因子：
16.2
通讯作者：
Beck, Roy W.
中科院分区：
文献类型：
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作者：
Maahs, David M.;Calhoun, Peter;Beck, Roy W.
目的 1 型糖尿病患者经常发生夜间低血糖，并可能导致意识丧失、癫痫发作，甚至死亡。我们进行了一项家庭随机试验，以确定当通过基于连续血糖监测 (CGM) 血糖水平的算法预测低血糖时，是否可以通过暂时停止泵胰岛素输送来安全地减少夜间低血糖。 研究设计和方法在初始磨合阶段后，在 45 名 15-45 岁 1 型糖尿病患者中进行了为期 42 晚的试验，其中每晚被随机分配为具有预测性的受试者低血糖暂停系统活跃（干预之夜）或不活跃（控制之夜）。主要结果是 2 小时 CGM 血糖值 >= 1 的夜晚比例降低了 74%。 57% 的对照夜间和 59% 的干预夜间，夜间传感器血糖 > 180 mg/dL (P = 0.17)，而分别在 21% 和 27% 的夜晚后早晨血糖 > 180 mg/dL (P < 0.001)，在 6% 和 6% 的夜晚分别 > 250 mg/dL。每组中早晨酮症出现的时间< 1%。 结论 使用夜间低血糖暂停系统可以显着减少夜间低血糖，而不会增加早晨酮症。
OBJECTIVEOvernight hypoglycemia occurs frequently in individuals with type 1 diabetes and can result in loss of consciousness, seizure, or even death. We conducted an in-home randomized trial to determine whether nocturnal hypoglycemia could be safely reduced by temporarily suspending pump insulin delivery when hypoglycemia was predicted by an algorithm based on continuous glucose monitoring (CGM) glucose levels.RESEARCH DESIGN AND METHODSFollowing an initial run-in phase, a 42-night trial was conducted in 45 individuals aged 15-45 years with type 1 diabetes in which each night was assigned randomly to either having the predictive low-glucose suspend system active (intervention night) or inactive (control night). The primary outcome was the proportion of nights in which >= 1 CGM glucose values 2 h was reduced by 74%. Overnight sensor glucose was > 180 mg/dL during 57% of control nights and 59% of intervention nights (P = 0.17), while morning blood glucose was > 180 mg/dL following 21% and 27% of nights, respectively (P < 0.001), and > 250 mg/dL following 6% and 6%, respectively. Morning ketosis was present < 1% of the time in each arm.CONCLUSIONSUse of a nocturnal low-glucose suspend system can substantially reduce overnight hypoglycemia without an increase in morning ketosis.