开源自动化胰岛素输送在 1 型糖尿病中的应用。
Open-Source Automated Insulin Delivery in Type 1 Diabetes.
机构信息
From the Departments of Pediatrics (M.J.B., R.A.M., O.J.S., M.I.B.) and Population Health (J.A.W.), University of Otago, and the Department of Pediatrics, Canterbury District Health Board (M.J.B., O.J.S., M.I.B.), Christchurch, Te Huataki Waiora School of Health, Sport and Human Performance, University of Waikato (H.R.C.), and Waikato Regional Diabetes Service, Waikato District Health Board (R.G.P., C.S.L., S.K.J.P.), Hamilton, the Department of Pediatric Endocrinology, Starship Children's Health, Auckland District Health Board (C.A.J., A.M.F., C.L.), and the Liggins Institute, University of Auckland (C.A.J.), Auckland, the Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago (C.M.F., S.D.J., B.J.W.), and the Pediatric Department, Southern District Health Board (B.J.W.), Dunedin, and Nightscout New Zealand, Hamilton (T.C.G.) - all in New Zealand; and OpenAPS, Seattle (D.M.L.).
出版信息
N Engl J Med. 2022 Sep 8;387(10):869-881. doi: 10.1056/NEJMoa2203913.
BACKGROUND
Open-source automated insulin delivery (AID) systems are used by many patients with type 1 diabetes. Data are needed on the efficacy and safety of an open-source AID system.
METHODS
In this multicenter, open-label, randomized, controlled trial, we assigned patients with type 1 diabetes in a 1:1 ratio to use an open-source AID system or a sensor-augmented insulin pump (control). The patients included both children (defined as 7 to 15 years of age) and adults (defined as 16 to 70 years of age). The AID system was a modified version of AndroidAPS 2.8 (with a standard OpenAPS 0.7.0 algorithm) paired with a preproduction DANA-i insulin pump and Dexcom G6 CGM, which has an Android smartphone application as the user interface. The primary outcome was the percentage of time in the target glucose range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter) between days 155 and 168 (the final 2 weeks of the trial).
RESULTS
A total of 97 patients (48 children and 49 adults) underwent randomization (44 to open-source AID and 53 to the control group). At 24 weeks, the mean (±SD) time in the target range increased from 61.2±12.3% to 71.2±12.1% in the AID group and decreased from 57.7±14.3% to 54.5±16.0% in the control group (adjusted difference, 14 percentage points; 95% confidence interval, 9.2 to 18.8; P<0.001), with no treatment effect according to age (P = 0.56). Patients in the AID group spent 3 hours 21 minutes more in the target range per day than those in the control group. No severe hypoglycemia or diabetic ketoacidosis occurred in either group. Two patients in the AID group withdrew from the trial owing to connectivity issues.
CONCLUSIONS
In children and adults with type 1 diabetes, the use of an open-source AID system resulted in a significantly higher percentage of time in the target glucose range than the use of a sensor-augmented insulin pump at 24 weeks. (Supported by the Health Research Council of New Zealand; Australian New Zealand Clinical Trials Registry number, ACTRN12620000034932.).
背景
许多 1 型糖尿病患者使用开源自动化胰岛素输送（AID）系统。我们需要了解开源 AID 系统的疗效和安全性数据。
方法
在这项多中心、开放标签、随机对照试验中，我们将 1 型糖尿病患者按照 1:1 的比例随机分配至使用开源 AID 系统或传感器增强型胰岛素泵（对照组）。患者包括儿童（定义为 7 至 15 岁）和成人（定义为 16 至 70 岁）。AID 系统是 AndroidAPS 2.8 的修改版本（带有标准 OpenAPS 0.7.0 算法），与预生产的 DANA-i 胰岛素泵和 Dexcom G6 CGM 配对，后者具有 Android 智能手机应用程序作为用户界面。主要结局是在第 155 天至 168 天（试验的最后 2 周）期间，目标血糖范围（70 至 180mg/dL，3.9 至 10.0mmol/L）的时间百分比。
结果
共有 97 名患者（48 名儿童和 49 名成人）接受了随机分组（44 名至开源 AID 组和 53 名至对照组）。在 24 周时，AID 组的目标范围内时间从 61.2±12.3%增加到 71.2±12.1%，对照组从 57.7±14.3%下降至 54.5±16.0%（调整差异，14 个百分点；95%置信区间，9.2 至 18.8；P<0.001），且与年龄无关（P=0.56）。AID 组患者每天在目标范围内的时间比对照组多 3 小时 21 分钟。两组均未发生严重低血糖或糖尿病酮症酸中毒。AID 组有 2 名患者因连接问题退出试验。
结论
在 1 型糖尿病儿童和成人中，与使用传感器增强型胰岛素泵相比，使用开源 AID 系统在 24 周时可使目标血糖范围内的时间百分比显著提高。（由新西兰健康研究委员会资助；澳大利亚和新西兰临床试验注册编号，ACTRN12620000034932.）。
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