Abraham Mary B, Smith Grant J, Dart Julie, Clarke Antony, Bebbington Keely, Fairchild Janice M, Ambler Geoffrey R, Cameron Fergus J, Davis Elizabeth A, Jones Timothy W
Children's Diabetes Centre, Telethon Kids Institute, The University of Western Australia, Perth, Australia.
Department of Endocrinology and Diabetes, Perth Children's Hospital, Perth, Australia.
Diabetes Care. 2025 Jan 1;48(1):67-75. doi: 10.2337/dc24-0276.
To determine the efficacy of advanced hybrid closed-loop (AHCL) therapy in a high-risk cohort of youth on continuous subcutaneous insulin infusion (CSII) with or without continuous glucose monitoring (CGM) with suboptimal glycemia.
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.
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.
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.
确定先进混合闭环（AHCL）疗法在血糖控制不佳的接受持续皮下胰岛素输注（CSII）且使用或未使用持续葡萄糖监测（CGM）的高危青年人群中的疗效。
在一项为期6个月的多中心临床试验中，1型糖尿病且平均及最近糖化血红蛋白（HbA1c）>8.5%（65 mmol/mol）的青年被按1:1随机分配至AHCL组或常规治疗组（CSII±CGM）。主要结局是24周时两组间HbA1c的差异。次要结局包括来自隐蔽式CGM的指标以及使用经过验证的问卷评估的心理指标（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）。
共42名参与者被随机分组（平均[标准差]年龄16.2[2.5]岁，HbA1c 9.8[1.1]%或84[12]mmol/mol，PAID评分50.3[19.8]）。在研究结束时，AHCL组的平均（标准差）HbA1c为8.8（1.1）%或73（12）mmol/mol，CSII±CGM组为9.9（1.2）%或85（13.1）mmol/mol，平均调整后组间差异为-0.77%（95%置信区间-1.45至-0.09）或-8.4 mmol/mol（-15.8至-1.0）；P=0.027。AHCL增加了血糖在70-180 mg/dL范围内的时间（差异19.1%；95%置信区间11.1至27.1），减少了血糖>180 mg/dL的时间（差异-17.7%；95%置信区间-26.6至-8.8），而血糖<70 mg/dL的时间没有增加（差异-0.8%；95%置信区间-2.7至0.6）。在研究结束时，没有证据表明两组间心理社会结局存在差异。
对于血糖控制不佳的青年，应鼓励使用AHCL，因为AHCL可改善血糖水平。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糖尿病护理的负担。
