Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes
Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes
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DOI：
10.1056/nejmoa1907863
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发表时间：
2019-10-31
影响因子：
158.5
通讯作者：
Beck, R. W.
中科院分区：
文献类型：
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作者：
Brown, S. A.;Kovatchev, B. P.;Beck, R. W.
闭环系统，自动胰岛素输送可能会改善1型diabetes. METHODS患者的血糖结果在这个6个月的随机，多中心试验中，1型糖尿病患者被分配在2：1的比例接受治疗与闭环系统（闭环组）或传感器增强泵（对照组）。主要结果是血糖水平在70 - 180 mg/dl（3.9 - 10.0 mmol/L）目标范围内的时间百分比，通过连续血糖监测进行测量。共有168例患者接受了随机分组; 112例被分配到闭环组，56例被分配到对照组。患者的年龄范围为14至71岁，糖化血红蛋白水平范围为5.4%至10.6%。所有168例患者均完成了试验。闭环组血糖水平在目标范围内的平均（+/- SD）时间百分比从基线时的61 +/- 17%增加到6个月期间的71 +/- 12%，对照组保持不变，为59 +/- 14%（平均校正差异，11个百分点; 95%置信区间[CI]，9 - 14; P180 mg/dl、平均葡萄糖水平、糖化血红蛋白水平和葡萄糖水平低于
BACKGROUNDClosed-loop systems that automate insulin delivery may improve glycemic outcomes in patients with type 1 diabetes.METHODSIn this 6-month randomized, multicenter trial, patients with type 1 diabetes were assigned in a 2:1 ratio to receive treatment with a closed-loop system (closed-loop group) or a sensor-augmented pump (control group). The primary outcome was the percentage of time that the blood glucose level was within the target range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter), as measured by continuous glucose monitoring.RESULTSA total of 168 patients underwent randomization; 112 were assigned to the closed-loop group, and 56 were assigned to the control group. The age range of the patients was 14 to 71 years, and the glycated hemoglobin level ranged from 5.4 to 10.6%. All 168 patients completed the trial. The mean (+/- SD) percentage of time that the glucose level was within the target range increased in the closed-loop group from 61 +/- 17% at baseline to 71 +/- 12% during the 6 months and remained unchanged at 59 +/- 14% in the control group (mean adjusted difference, 11 percentage points; 95% confidence interval [CI], 9 to 14; P180 mg per deciliter, mean glucose level, glycated hemoglobin level, and percentage of time that the glucose level was