本期文章：《新英格兰医学杂志》：Vol.387 No.13

美国马萨诸塞州总医院Steven J. Russell团队研究了仿生胰腺治疗1型糖尿病患者的疗效。相关论文于2022年9月28日发表在《新英格兰医学杂志》上。

目前可用的半自动胰岛素输送系统需要个性化的胰岛素方案来初始化治疗，并根据碳水化合物计数来确定日常操作中的膳食量。相比之下，仿生胰腺仅根据体重进行初始化，做出所有计量的决定并自动输送胰岛素，并且使用膳食通知而不计算碳水化合物。

在这项为期13周的多中心随机试验中，研究组将至少6岁的1型糖尿病患者按2:1的比例随机分为两组，一组接受天冬氨酸胰岛素或赖脯胰岛素的仿生胰腺治疗，另一组接受标准护理（定义为无盲、实时连续血糖监测的任何胰岛素给药方法）。主要结局是13周时糖化血红蛋白水平。关键次要结局是通过持续血糖监测评估的血糖水平低于54 mg/dl的时间百分比；该结果预先指定非劣效性限值为1个百分点。研究组对安全性也进行了评估。

共有219名6至79岁的参与者被分配到仿生胰腺组，107名被分配到标准护理组。仿生胰腺组糖化血红蛋白水平从7.9%降至7.3%，而标准护理组的糖化血红蛋白水平（两个时间点均为7.7%）没有变化，组间差异显著。两组之间通过持续血糖监测评估的血糖水平低于54 mg/dl的时间百分比没有显著差异。仿生胰腺组的严重低血糖发生率为17.7/100参与者-年，标准护理组为10.8/100参与者-年。两组均未发生糖尿病酮症酸中毒。

研究结果表明，在这项为期13周的随机试验中，成人和儿童1型糖尿病患者使用仿生胰腺，与标准护理相比，糖化血红蛋白水平降低更多。

附：英文原文

Title: Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes

Author: Bionic Pancreas Research Group

Issue&Volume: 2022-09-28

Abstract:

Background

Currently available semiautomated insulin-delivery systems require individualized insulin regimens for the initialization of therapy and meal doses based on carbohydrate counting for routine operation. In contrast, the bionic pancreas is initialized only on the basis of body weight, makes all dose decisions and delivers insulin autonomously, and uses meal announcements without carbohydrate counting.

Methods

In this 13-week, multicenter, randomized trial, we randomly assigned in a 2:1 ratio persons at least 6 years of age with type 1 diabetes either to receive bionic pancreas treatment with insulin aspart or insulin lispro or to receive standard care (defined as any insulin-delivery method with unblinded, real-time continuous glucose monitoring). The primary outcome was the glycated hemoglobin level at 13 weeks. The key secondary outcome was the percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter; the prespecified noninferiority limit for this outcome was 1 percentage point. Safety was also assessed.

Results

A total of 219 participants 6 to 79 years of age were assigned to the bionic-pancreas group, and 107 to the standard-care group. The glycated hemoglobin level decreased from 7.9% to 7.3% in the bionic-pancreas group and did not change (was at 7.7% at both time points) in the standard-care group (mean adjusted difference at 13 weeks, 0.5 percentage points; 95% confidence interval [CI], 0.6 to 0.3; P<0.001). The percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter did not differ significantly between the two groups (13-week adjusted difference, 0.0 percentage points; 95% CI, 0.1 to 0.04; P<0.001 for noninferiority). The rate of severe hypoglycemia was 17.7 events per 100 participant-years in the bionic-pancreas group and 10.8 events per 100 participant-years in the standard-care group (P=0.39). No episodes of diabetic ketoacidosis occurred in either group.

Conclusions

In this 13-week, randomized trial involving adults and children with type 1 diabetes, use of a bionic pancreas was associated with a greater reduction than standard care in the glycated hemoglobin level.

DOI: 10.1056/NEJMoa2205225