美国弗吉尼亚大学糖尿病技术中心Boris P. Kovatchev课题组，进行了一项闭环控制治疗1型糖尿病的6个月随机多中心试验。 2019年10月16日，《新英格兰医学杂志》在线发表了这一成果。

闭环自动胰岛素输送系统或许可改善1型糖尿病患者的血糖结局。

在这项为期6个月的随机多中心试验中，研究组共招募了168名1型糖尿病患者，年龄为14-71岁，糖化血红蛋白水平为5.4-10.6%。将其按2：1随机分配，其中112名接受闭环胰岛素输送系统治疗（闭环组），56名接受传感器增强泵疗法（对照组）。血糖控制的目标范围为70-180 mg/dL（3.9-10.0 mmol/L），低于此范围为低血糖，高于此范围为高血糖。

6个月后，闭环组血糖水平控制在目标范围内的时间所占百分比从基线时的61±17%增至71±12%，而对照组则保持在59±14%不变，两组间差异显著。闭环组的高血糖时间所占百分比、血糖水平、糖化血红蛋白水平、低血糖时间所占百分比等指标均优于对照组，其中低血糖时间百分比比对照组少0.88个百分点，6个月后糖化血红蛋白水平比对照组低0.33个百分点。两组均未发生严重低血糖事件，闭环组中发生1例糖尿病酮症酸中毒。

综上，与传感器增强胰岛素泵相比，闭环系统更有助于将1型糖尿病患者的血糖控制在目标范围之内。

附：英文原文

Title: Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes

Author: Sue A. Brown, Boris P. Kovatchev, Dan Raghinaru, John W. Lum, Bruce A. Buckingham, Yogish C. Kudva, Lori M. Laffel, Carol J. Levy, Jordan E. Pinsker, R. Paul Wadwa, Eyal Dassau, Francis J. Doyle III, Stacey M. Anderson, Mei Mei Church, Vikash Dadlani, Laya Ekhlaspour, Gregory P. Forlenza, Elvira Isganaitis, David W. Lam, Craig Kollman, Roy W. Beck

Issue&Volume: 2019-10-16

Abstract: 

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. 

DOI: 10.1056/NEJMoa1907863

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1907863