Importance Hybrid closed-loop (HCL) therapy has improved glycemic control in children and adolescents with type 1 diabetes; however, the efficacy of HCL on glycemic and psychosocial outcomes has not yet been established in a long-term randomized clinical trial. Objective To determine the percentage of time spent in the target glucose range using HCL vs current conventional therapies of continuous subcutaneous insulin infusion or multiple daily insulin injections with or without continuous glucose monitoring (CGM). Design, Setting, and Participants This 6-month, multicenter, randomized clinical trial included 172 children and adolescents with type 1 diabetes; patients were recruited between April 18, 2017, and October 4, 2019, in Australia. Data were analyzed from July 25, 2020, to February 26, 2021. Interventions Eligible participants were randomly assigned to either the control group for conventional therapy (continuous subcutaneous insulin infusion or multiple daily insulin injections with or without CGM) or the intervention group for HCL therapy. Main Outcomes and Measures The primary outcome was the percentage of time in range (TIR) within a glucose range of 70 to 180 mg/dL, measured by 3-week masked CGM collected at the end of the study in both groups. Secondary outcomes included CGM metrics for hypoglycemia, hyperglycemia, and glycemic variability and psychosocial measures collected by validated questionnaires. Results A total of 135 patients (mean [SD] age, 15.3 [3.1] years; 76 girls [56%]) were included, with 68 randomized to the control group and 67 to the HCL group. Patients had a mean (SD) diabetes duration of 7.7 (4.3) years and mean hemoglobin A1c of 64 (11) mmol/mol, with 110 participants (81%) receiving continuous subcutaneous insulin infusion and 72 (53%) receiving CGM. In the intention-to-treat analyses, TIR increased from a mean (SD) of 53.1% (13.0%) at baseline to 62.5% (12.0%) at the end of the study in the HCL group and from 54.6% (12.5%) to 56.1% (12.2%) in the control group, with a mean adjusted difference between the 2 groups of 6.7% (95% CI, 2.7%-10.8%; P = .002). Hybrid closed-loop therapy also reduced the time that patients spent in a hypoglycemic (<70 mg/dL) range (difference, -1.9%; 95% CI, -2.5% to -1.3%) and improved glycemic variability (coefficient of variation difference, -5.7%; 95% CI, -10.2% to -0.9%). Hybrid closed-loop therapy was associated with improved diabetes-specific quality of life (difference, 4.4 points; 95% CI, 0.4-8.4 points), with no change in diabetes distress. There were no episodes of severe hypoglycemia or diabetic ketoacidosis in either group. Conclusions and Relevance In this randomized clinical trial, 6 months of HCL therapy significantly improved glycemic control and quality of life compared with conventional therapy in children and adolescents with type 1 diabetes. Trial Registration ANZCTR identifier: ACTRN12616000753459.

中文翻译：

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混合闭环系统对 1 型糖尿病儿童和青少年血糖和心理社会结果的影响：一项随机临床试验。

重要性 混合闭环 (HCL) 疗法改善了 1 型糖尿病儿童和青少年的血糖控制；然而，HCL 对血糖和心理社会结果的疗效尚未在长期随机临床试验中确定。目的 确定使用 HCL 与当前的连续皮下胰岛素输注或每日多次胰岛素注射（有或没有连续血糖监测 (CGM)）的常规疗法相比，在目标血糖范围内花费的时间百分比。设计、地点和参与者 这项为期 6 个月的多中心随机临床试验包括 172 名患有 1 型糖尿病的儿童和青少年；患者于 2017 年 4 月 18 日至 2019 年 10 月 4 日期间在澳大利亚招募。数据分析时间为 2020 年 7 月 25 日至 2021 年 2 月 26 日。干预 符合条件的参与者被随机分配到常规治疗的对照组（连续皮下胰岛素输注或每日多次注射胰岛素，加或不加 CGM）或 HCL 治疗的干预组。主要结果和测量 主要结果是在 70 至 180 mg/dL 的葡萄糖范围内的时间范围 (TIR) 百分比，通过在研究结束时在两组中收集的 3 周掩蔽 CGM 测量。次要结果包括低血糖、高血糖和血糖变异性的 CGM 指标以及通过验证问卷收集的社会心理指标。结果共纳入 135 例患者（平均 [SD] 年龄，15.3 [3.1] 岁；76 名女孩 [56%]），其中对照组 68 例，HCL 组 67 例。患者的平均 (SD) 糖尿病病程为 7.7 (4. 3) 年，平均血红蛋白 A1c 为 64 (11) mmol/mol，其中 110 名参与者 (81%) 接受持续皮下胰岛素输注，72 名参与者 (53%) 接受 CGM。在意向治疗分析中，HCL 组的 TIR 从基线时的平均 (SD) 53.1% (13.0%) 增加到研究结束时的 62.5% (12.0%) 和从 54.6% (12.5%) ) 至对照组的 56.1% (12.2%)，两组之间的平均调整差异为 6.7% (95% CI, 2.7%-10.8%; P = .002)。混合闭环治疗还减少了患者在低血糖 (<70 mg/dL) 范围内花费的时间（差异，-1.9%；95% CI，-2.5% 至 -1.3%）并改善了血糖变异性（变异系数差异，-5.7%；95% CI，-10.2% 至 -0.9%）。混合闭环治疗与改善糖尿病特异性生活质量相关（差异，4.4 分；95% CI，0.4-8。4 分），糖尿病困扰没有变化。两组均未发生严重低血糖或糖尿病酮症酸中毒。结论和相关性 在这项随机临床试验中，与常规治疗相比，6 个月的 HCL 治疗显着改善了患有 1 型糖尿病的儿童和青少年的血糖控制和生活质量。试用注册 ANZCTR 标识符：ACTRN12616000753459。