MD-Logic Overnight Control for 6 Weeks of Home Use in Patients With Type 1 Diabetes: Randomized Crossover Trial
MD-Logic Overnight Control for 6 Weeks of Home Use in Patients With Type 1 Diabetes: Randomized Crossover Trial
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DOI：
10.2337/dc14-0835
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发表时间：
2014-11-01
期刊：
影响因子：
16.2
通讯作者：
Phillip, Moshe
中科院分区：
文献类型：
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作者：
Nimri, Revital;Muller, Ido;Phillip, Moshe
我们评估了MD-Logic系统在患者家中过夜血糖控制的效果。研究设计和方法（年龄12-43岁;平均A（1c）7.5 +/-0.8%，58.1 +/- 8.4 mmol/mol）被随机分配参加两个过夜交叉期，每个交叉期包括6周的连续夜晚：一个在闭环下，第二个在现实生活条件下在患者家中的传感器增强泵（SAP）治疗下。主要终点是传感器葡萄糖水平低于70 mg/dL（3.9 mmol/L）过夜的时间。结果与使用SAP治疗的夜晚相比，闭环夜晚显著减少了低血糖的时间（P = 0.02），并增加了目标范围70-140 mg/dL（P = 0.003）的时间百分比。与SAP治疗相比，在闭环控制下，240 mg/dL以上的高血糖持续时间中位数减少52.2%（四分位距[IQR] 4.8，72.9%; P = 0.001）。与SAP组相比，闭环组的夜间总胰岛素剂量较低（P = 0.04）。闭环手术后的平均日间血糖水平降低了10.0 mg/dL（IQR - 2.7，19.2; P = 0.017），而使用的总胰岛素剂量较低（P = 0.038）。在闭环控制过程中没有发生严重的不良事件，有一个单一的严重低血糖事件，在控制night.CONCLUSIONS长期家庭使用的自动化过夜胰岛素输送的MD逻辑系统被发现是一个可行的，安全的，有效的工具，以减少夜间低血糖和改善1型糖尿病患者的夜间血糖控制。
OBJECTIVEWe evaluated the effect of the MD-Logic system on overnight glycemic control at patients' homes.RESEARCH DESIGN AND METHODS Twenty-four patients (aged 12-43 years; average A(1c) 7.5 +/- 0.8%, 58.1 +/- 8.4 mmol/mol) were randomly assigned to participate in two overnight crossover periods, each including 6 weeks of consecutive nights: one under closed loop and the second under sensor-augmented pump (SAP) therapy at patients' homes in real-life conditions. The primary end point was time spent with sensor glucose levels below 70 mg/dL (3.9 mmol/L) overnight.RESULTS Closed-loop nights significantly reduced time spent in hypoglycemia (P = 0.02) and increased the percentage of time spent in the target range of 70-140 mg/dL (P = 0.003) compared with nights when the SAP therapy was used. The time spent in substantial hyperglycemia above 240 mg/dL was reduced by a median of 52.2% (interquartile range [IQR] 4.8, 72.9%; P = 0.001) under closed-loop control compared with SAP therapy. Overnight total insulin doses were lower in the closed-loop nights compared with the SAP nights (P = 0.04). The average daytime glucose levels after closed-loop operation were reduced by a median of 10.0 mg/dL (IQR - 2.7, 19.2; P = 0.017) while lower total insulin doses were used (P = 0.038). No severe adverse events occurred during closed-loop control; there was a single event of severe hypoglycemia during a control night.CONCLUSIONS The long-term home use of automated overnight insulin delivery by the MD-Logic system was found to be a feasible, safe, and an effective tool to reduce nocturnal hypoglycemia and improve overnight glycemic control in subjects with type 1 diabetes.