Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes.
Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes.
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DOI：
10.1056/nejmoa2210834
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发表时间：
2023-03-16
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胰岛素输送的闭环控制系统可改善1型糖尿病幼儿的血糖结果。启动闭环系统的有效性和安全性实际上尚不清楚。在这项为期13周的多中心试验中，我们以2：1的比例随机分配了至少2岁但小于6岁的1型糖尿病儿童，接受胰岛素输送闭环系统治疗或标准护理，包括胰岛素泵或每日多次注射胰岛素加连续葡萄糖监测仪。主要结局是通过连续血糖监测测量的血糖水平在70 - 180 mg/dl目标范围内的时间百分比。次要结局包括血糖水平高于250 mg/dl或低于70 mg/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。共有102名儿童接受了随机分组（68名进入闭环组，34名进入标准治疗组）;基线糖化血红蛋白水平范围为5.2%至11.5%。55例患者（81%）的闭环系统启动是虚拟的。闭环治疗组血糖水平在目标范围内的平均（±SD）时间百分比从基线时的56.7±18.0%增加至13周随访期间的69.3±11.1%，标准治疗组从54.9±14.7%增加至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）。我们在血糖水平高于250 mg/dl的时间百分比、平均血糖水平和糖化血红蛋白水平方面观察到相似的治疗效果（有利于闭环系统），在血糖水平低于70 mg/dl的时间百分比方面无显著组间差异。闭环组有2例重度低血糖，标准治疗组有1例。闭环组发生1例糖尿病酮症酸中毒。在这项涉及1型糖尿病幼儿的试验中，与标准护理相比，闭环系统的葡萄糖水平在目标范围内的时间百分比更大。（由国家糖尿病、消化和肾脏疾病研究所资助; PEDAP ClinicalTrials.gov编号，NCT 04796779。
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. 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. 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. 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.)