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Fully automated closed-loop glucose control compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis: an open-label, randomized crossover trial
Nature Medicine ( IF 82.9 ) Pub Date : 2021-08-04 , DOI: 10.1038/s41591-021-01453-z
Charlotte K Boughton 1, 2 , Afroditi Tripyla 3 , Sara Hartnell 2 , Aideen Daly 1 , David Herzig 3 , Malgorzata E Wilinska 1 , Cecilia Czerlau 4 , Andrew Fry 5 , Lia Bally 3 , Roman Hovorka 1
Affiliation  

We evaluated the safety and efficacy of fully closed-loop insulin therapy compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis. In an open-label, multinational, two-center, randomized crossover trial, 26 adults with type 2 diabetes requiring dialysis (17 men, 9 women, average age 68 ± 11 years (mean ± s.d.), diabetes duration of 20 ± 10 years) underwent two 20-day periods of unrestricted living, comparing the Cambridge fully closed-loop system using faster insulin aspart (‘closed-loop’) with standard insulin therapy and a masked continuous glucose monitor (‘control’) in random order. The primary endpoint was time in target glucose range (5.6–10.0 mmol l−1). Thirteen participants received closed-loop first and thirteen received control therapy first. The proportion of time in target glucose range (5.6–10.0 mmol l−1; primary endpoint) was 52.8 ± 12.5% with closed-loop versus 37.7 ± 20.5% with control; mean difference, 15.1 percentage points (95% CI 8.0–22.2; P < 0.001). Mean glucose was lower with closed-loop than control (10.1 ± 1.3 versus 11.6 ± 2.8 mmol l−1; P = 0.003). Time in hypoglycemia (<3.9 mmol l−1) was reduced with closed-loop versus control (median (IQR) 0.1 (0.0–0.4%) versus 0.2 (0.0–0.9%); P = 0.040). No severe hypoglycemia events occurred during the control period, whereas one severe hypoglycemic event occurred during the closed-loop period, but not during closed-loop operation. Fully closed-loop improved glucose control and reduced hypoglycemia compared with standard insulin therapy in adult outpatients with type 2 diabetes requiring dialysis. The trial registration number is NCT04025775.



中文翻译:

全自动闭环血糖控制与标准胰岛素治疗在需要透析的 2 型糖尿病成人患者中的比较:一项开放标签、随机交叉试验

我们在需要透析的 2 型糖尿病成人中评估了完全闭环胰岛素治疗与标准胰岛素治疗相比的安全性和有效性。在一项开放标签、多国、两中心、随机交叉试验中,26 名需要透析的 2 型糖尿病成年人(17 名男性,9 名女性,平均年龄 68 ± 11 岁(平均值 ± 标准差),糖尿病病程 20 ± 10 年) 经历了两次为期 20 天的无限制生活,比较了剑桥全闭环系统,使用更快的门冬胰岛素(“闭环”)与标准胰岛素治疗和蒙面连续血糖监测仪(“控制”)以随机顺序进行。主要终点是目标葡萄糖范围内的时间(5.6-10.0 mmol l -1)。十三名参与者首先接受闭环治疗,十三名首先接受对照治疗。目标葡萄糖范围内的时间比例(5.6-10.0 mmol l -1;主要终点)闭环为 52.8 ± 12.5%,而对照为 37.7 ± 20.5%;平均差,15.1 个百分点(95% CI 8.0–22.2;P  < 0.001)。闭环的平均葡萄糖低于对照(10.1 ± 1.3 对 11.6 ± 2.8 mmol l -1P  = 0.003)。闭环与对照相比,低血糖时间 (<3.9 mmol l -1 ) 减少(中位数 (IQR) 0.1 (0.0–0.4%) 与 0.2 (0.0–0.9%); P = 0.040)。在控制期间没有发生严重低血糖事件,而在闭环期间发生了1次严重低血糖事件,但在闭环操作期间没有发生。与需要透析的成人 2 型糖尿病门诊患者的标准胰岛素治疗相比,完全闭环改善了血糖控制并减少了低血糖。试用注册号为 NCT04025775。

更新日期:2021-08-04
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