BACKGROUND Closed-loop systems that automate insulin delivery may improve glycemic outcomes in patients with type 1 diabetes. METHODS In 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. RESULTS A 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; P<0.001). The results with regard to the main secondary outcomes (percentage of time that the glucose level was >180 mg per deciliter, mean glucose level, glycated hemoglobin level, and percentage of time that the glucose level was <70 mg per deciliter or <54 mg per deciliter [3.0 mmol per liter]) all met the prespecified hierarchical criterion for significance, favoring the closed-loop system. The mean difference (closed loop minus control) in the percentage of time that the blood glucose level was lower than 70 mg per deciliter was -0.88 percentage points (95% CI, -1.19 to -0.57; P<0.001). The mean adjusted difference in glycated hemoglobin level after 6 months was -0.33 percentage points (95% CI, -0.53 to -0.13; P = 0.001). In the closed-loop group, the median percentage of time that the system was in closed-loop mode was 90% over 6 months. No serious hypoglycemic events occurred in either group; one episode of diabetic ketoacidosis occurred in the closed-loop group. CONCLUSIONS In this 6-month trial involving patients with type 1 diabetes, the use of a closed-loop system was associated with a greater percentage of time spent in a target glycemic range than the use of a sensor-augmented insulin pump. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases; iDCL ClinicalTrials.gov number, NCT03563313.).

中文翻译：

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1 型糖尿病闭环控制的六个月随机、多中心试验。


背景技术自动输送胰岛素的闭环系统可以改善1型糖尿病患者的血糖结果。方法 在这项为期 6 个月的随机、多中心试验中，1 型糖尿病患者按照 2:1 的比例被分配接受闭环系统（闭环组）或传感器增强泵（对照组）的治疗。主要结果是通过连续血糖监测测量血糖水平处于 70 至 180 毫克每分升（3.9 至 10.0 毫摩尔每升）目标范围内的时间百分比。结果 共有 168 名患者接受了随机分组； 112 人被分配到闭环组，56 人被分配到对照组。患者年龄范围为14至71岁，糖化血红蛋白水平为5.4%至10.6%。所有 168 名患者均完成了试验。闭环组中血糖水平处于目标范围内的平均 (±SD) 时间百分比从基线时的 61±17% 增加到 6 个月期间的 71±12%，并且在 2017 年保持不变，为 59±14%。对照组（平均调整差异，11 个百分点；95% 置信区间 [CI]，9 至 14；P<0 id=3>180 毫克/分升，平均血糖水平、糖化血红蛋白水平以及葡萄糖水平<70毫克/分升或<54毫克/分升[3.0毫摩尔/升]）都满足预先指定的显着性分层标准，有利于闭环系统。血糖水平低于 70 mg/dL 的时间百分比的平均差异（闭环减去对照）为 -0.88 个百分点（95% CI，-1.19 至 -0.57；P<0.001）。 6 个月后糖化血红蛋白水平的平均调整差异为 -0.33 个百分点（95% CI，-0.53 至 -0.13；P = 0.001）。 在闭环组中，6 个月内系统处于闭环模式的时间中位数百分比为 90%。两组均未发生严重低血糖事件；闭环组发生1次糖尿病酮症酸中毒。结论 在这项针对 1 型糖尿病患者的为期 6 个月的试验中，与使用传感器增强型胰岛素泵相比，使用闭环系统与在目标血糖范围内花费的时间百分比更高相关。 （由国家糖尿病、消化和肾脏疾病研究所资助；iDCL ClinicalTrials.gov 编号，NCT03563313。）。