OBJECTIVE To determine the efficacy of advanced hybrid closed loop (AHCL) therapy in a high-risk cohort of youth on continuous subcutaneous insulin infusion (CSII) ± continuous glucose monitoring (CGM) with suboptimal glycemia. RESEARCH DESIGN AND METHODS In a 6-month multicenter clinical trial, youth with type 1 diabetes with mean and most recent HbA1c > 8.5% (65 mmol/mol) were randomly assigned 1:1 to AHCL or treatment as usual (CSII ± CGM). The primary outcome was the 24-week between-group difference in HbA1c. Secondary outcomes included CGM metrics from masked CGM and psychological measures (youth-reported problem areas in diabetes [PAID], quality of life, anxiety, depression, and hypoglycemia fear) assessed using validated questionnaires. RESULTS A total of 42 participants were randomized (mean [SD] age 16.2 [2.5] years, HbA1c 9.8 [1.1]% or 84 [12] mmol/mol, PAID score 50.3 [19.8]). At study end, the mean (SD) HbA1c was 8.8 (1.1)% or 73 (12) mmol/mol with AHCL and 9.9 (1.2)% or 85 (13.1) mmol/mol with CSII ± CGM, with mean adjusted group difference of −0.77% (95% CI −1.45 to −0.09) or −8.4 mmol/mol (−15.8 to −1.0); P = 0.027. AHCL increased time in range 70–180 mg/dL (difference 19.1%; 95% CI 11.1 to 27.1), reduced time >180 mg/dL (difference −17.7%; 95% CI −26.6 to −8.8), with no increase in time spent <70 mg/dL (difference −0.8%; 95% CI −2.7 to 0.6). There was no evidence for difference in psychosocial outcomes between the two groups at study end. CONCLUSIONS AHCL should be encouraged in youth with suboptimal glycemia, as AHCL improves glycemia. However, psychological support remains vital, as technology alone may not be able to reduce the burden of diabetes care in this subgroup.

中文翻译：

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高级混合闭环疗法对高 HbA1c 青少年的血糖和心理社会结果：一项随机临床试验


目的 确定先进混合闭环 (AHCL) 疗法在高危青年群体中连续皮下胰岛素输注 (CSII) ± 连续血糖监测 (CGM) 和血糖次优的疗效。研究设计和方法 在一项为期 6 个月的多中心临床试验中，平均和最近 HbA1c > 8.5% (65 mmol/mol) 的 1 型糖尿病青年被随机分配至 AHCL 或照常治疗 (CSII ± CGM) ）。主要结局是 24 周组间 HbA1c 差异。次要结局包括使用经过验证的问卷评估的隐藏 CGM 的 CGM 指标和心理测量（青少年报告的糖尿病问题领域 [PAID]、生活质量、焦虑、抑郁和低血糖恐惧）。结果 共有 42 名参与者被随机分组​​（平均 [SD] 年龄 16.2 [2.5] 岁，HbA1c 9.8 [1.1]% 或 84 [12] mmol/mol，PAID 评分 50.3 [19.8]）。研究结束时，AHCL 的平均 (SD) HbA1c 为 8.8 (1.1)% 或 73 (12) mmol/mol，CSII ± CGM 的平均 (SD) HbA1c 为 9.9 (1.2)% 或 85 (13.1) mmol/mol，平均调整组间差异-0.77%（95% CI -1.45至-0.09）或-8.4 mmol/mol（-15.8至-1.0）； P = 0.027。 AHCL 在 70–180 mg/dL 范围内增加时间（差异 19.1%；95% CI 11.1 至 27.1），时间减少 >180 mg/dL（差异 -17.7%；95% CI -26.6 至 -8.8），没有增加花费的时间<70 mg/dL（差异-0.8%；95% CI -2.7至0.6）。在研究结束时，没有证据表明两组之间的心理社会结果存在差异。结论 应鼓励血糖未达到最佳水平的青少年进行 AHCL，因为 AHCL 可改善血糖。然而，心理支持仍然至关重要，因为仅靠技术可能无法减轻该亚组的糖尿病护理负担。