英国剑桥大学Charlotte K. Boughton等研究人员完成在需要透析的成人2型糖尿病患者中，全自动闭环血糖控制与标准胰岛素治疗相比的临床试验。相关论文于2021年8月4日在线发表在《自然—医学》杂志上。

研究人员评估了在需要透析的2型糖尿病成人患者中，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。在一项开放标签的多国双中心随机交叉试验中，26名需要透析的2型糖尿病成人患者（17名男性，9名女性，平均年龄68±11岁（平均数±SD），糖尿病病程20±10年）接受了两次为期20天的无限制生活，按随机顺序比较了剑桥全闭环系统使用更快的天冬胰岛素（'闭环'）与标准胰岛素治疗和蒙版连续血糖监测仪（'对照'）。主要终点是目标血糖范围（5.6-10.0 mmol l^-1）的时间。

13名参与者先接受闭环治疗，13名参与者先接受对照治疗。在目标葡萄糖范围（5.6-10.0 mmol l^-1；主要终点）的时间比例，闭环疗法为52.8±12.5%，对照疗法为37.7±20.5%；平均差异为15.1个百分点（95%CI为8.0-22.2；P＜0.001）。闭环系统的平均血糖低于对照组（10.1±1.3对11.6±2.8 mmol l^-1；P=0.003）。与对照组相比，闭环系统的低血糖时间（<3.9 mmol l^-1）有所减少（中位数（IQR）0.1（0.0-0.4%）对0.2（0.0-0.9%）；P=0.040）。对照组期间没有发生严重的低血糖事件，而闭环组期间发生了一次严重的低血糖事件，但在闭环操作期间没有发生。

与标准的胰岛素治疗相比，全闭环改善了需要透析的2型糖尿病成年门诊患者的血糖控制，并减少了低血糖的发生。该试验注册号为NCT04025775。

附：英文原文

Title: 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

Author: Boughton, Charlotte K., Tripyla, Afroditi, Hartnell, Sara, Daly, Aideen, Herzig, David, Wilinska, Malgorzata E., Czerlau, Cecilia, Fry, Andrew, Bally, Lia, Hovorka, Roman

Issue&Volume: 2021-08-04

Abstract: 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±11years (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 (5.6–10.0mmoll1). Thirteen participants received closed-loop first and thirteen received control therapy first. The proportion of time in target glucose range (5.6–10.0mmoll1; 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±2.8mmoll1; P=0.003). Time in hypoglycemia (<3.9mmoll1) 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.

DOI: 10.1038/s41591-021-01453-z

Source: https://www.nature.com/articles/s41591-021-01453-z