1 型糖尿病患儿闭环混合控制试验。
Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes.
机构信息
From the Barbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora (R.P.W., G.P.F.); the Jaeb Center for Health Research, Tampa, FL (Z.W.R., J.L., C.K., R.W.B.); the Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Stanford (B.A.B.), and the Division of Pediatric Endocrinology, University of California, San Francisco, San Francisco (L.E.) - both in California; and the University of Virginia Center for Diabetes Technology, Charlottesville (M.D.D., M.S., M.D.B.).
出版信息
N Engl J Med. 2023 Mar 16;388(11):991-1001. doi: 10.1056/NEJMoa2210834.
BACKGROUND
Closed-loop control systems of insulin delivery may improve glycemic outcomes in young children with type 1 diabetes. The efficacy and safety of initiating a closed-loop system virtually are unclear.
METHODS
In this 13-week, multicenter trial, we randomly assigned, in a 2:1 ratio, children who were at least 2 years of age but younger than 6 years of age who had type 1 diabetes to receive treatment with a closed-loop system of insulin delivery or standard care that included either an insulin pump or multiple daily injections of insulin plus a continuous glucose monitor. The primary outcome was the percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter, as measured by continuous glucose monitoring. Secondary outcomes included the percentage of time that the glucose level was above 250 mg per deciliter or below 70 mg per deciliter, the mean glucose level, the glycated hemoglobin level, and safety outcomes.
RESULTS
A total of 102 children underwent randomization (68 to the closed-loop group and 34 to the standard-care group); the glycated hemoglobin levels at baseline ranged from 5.2 to 11.5%. Initiation of the closed-loop system was virtual in 55 patients (81%). The mean (±SD) percentage of time that the glucose level was within the target range increased from 56.7±18.0% at baseline to 69.3±11.1% during the 13-week follow-up period in the closed-loop group and from 54.9±14.7% to 55.9±12.6% in the standard-care group (mean adjusted difference, 12.4 percentage points [equivalent to approximately 3 hours per day]; 95% confidence interval, 9.5 to 15.3; P<0.001). We observed similar treatment effects (favoring the closed-loop system) on the percentage of time that the glucose level was above 250 mg per deciliter, on the mean glucose level, and on the glycated hemoglobin level, with no significant between-group difference in the percentage of time that the glucose level was below 70 mg per deciliter. There were two cases of severe hypoglycemia in the closed-loop group and one case in the standard-care group. One case of diabetic ketoacidosis occurred in the closed-loop group.
CONCLUSIONS
In this trial involving young children with type 1 diabetes, the glucose level was in the target range for a greater percentage of time with a closed-loop system than with standard care. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases; PEDAP ClinicalTrials.gov number, NCT04796779.).
背景
胰岛素输送闭环控制系统可能会改善 1 型糖尿病儿童的血糖控制效果。启动闭环系统的疗效和安全性尚不清楚。
方法
在这项为期 13 周、多中心的试验中，我们按照 2:1 的比例将年龄至少 2 岁但不满 6 岁、患有 1 型糖尿病的儿童随机分配，接受胰岛素输送闭环系统治疗或包括胰岛素泵或多次每日胰岛素注射加连续血糖监测的标准治疗。主要结局是通过连续血糖监测测量的血糖水平处于 70 至 180mg/dL 目标范围内的时间百分比。次要结局包括血糖水平高于 250mg/dL 或低于 70mg/dL 的时间百分比、平均血糖水平、糖化血红蛋白水平和安全性结局。
结果
共有 102 名儿童接受了随机分组（闭环组 68 例，标准护理组 34 例）；基线时糖化血红蛋白水平为 5.2 至 11.5%。在 55 名患者（81%）中，闭环系统的启动是虚拟的。在闭环组中，血糖水平处于目标范围内的时间百分比从基线时的 56.7±18.0%增加到 13 周随访期间的 69.3±11.1%，而在标准护理组中，从 54.9±14.7%增加到 55.9±12.6%（平均调整差异，12.4 个百分点[相当于每天约 3 小时]；95%置信区间，9.5 至 15.3；P<0.001）。我们观察到在血糖水平高于 250mg/dL 的时间百分比、平均血糖水平和糖化血红蛋白水平上，治疗效果（有利于闭环系统）相似，而血糖水平低于 70mg/dL 的时间百分比无显著组间差异。闭环组有 2 例严重低血糖，标准护理组有 1 例。闭环组发生 1 例糖尿病酮症酸中毒。
结论
在这项涉及 1 型糖尿病儿童的试验中，闭环系统使血糖处于目标范围内的时间百分比高于标准护理。（由美国国立糖尿病、消化和肾脏疾病研究所资助；PEDAP ClinicalTrials.gov 编号，NCT04796779。）
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