OBJECTIVE Continuous glucose monitoring (CGM) combined with continuous subcutaneous insulin infusion (CSII) achieves better glycemic control than multi-injection therapy in people with type 2 diabetes. The effectiveness of closed-loop therapy needs to be further evaluated in this population. RESEARCH DESIGN AND METHODS The study objective was to measure the impact of a hybrid closed-loop device (DBLG1) compared with CSII + CGM on glycemic control in people with type 2 diabetes previously treated with CSII. The randomized, controlled, crossover, two-period, open-label, and multicenter study was conducted from August 2022 to July 2023 in 17 individuals (9 to receive 6 weeks of CSII + CGM first and 8 to receive 6 weeks of closed-loop therapy first). The primary end point was the percentage time in range (TIR: 70–180 mg/dL). Secondary outcomes were other CGM-glucose metrics, physical activity, and sleep objectively measured using 1-week actimetry. RESULTS Data were analyzed using a modified intention-to-treat approach. Mean age was 63 (SD 9) years and 35% were women. Mean HbA1c at inclusion was 7.9% (SD 0.9). TIR increased to 76.0% (interquartile range 69.0–84.0) during the closed-loop condition vs. 61.0% (interquartile range 55.0–70.0) during the CSII + CGM condition; mean difference was 15.0 percentage points (interquartile range 8.0–22.0; P < 0.001). Analyses of secondary end points showed a decrease in time above range, in glucose management indicator, in glucose variability, and an increase in daily insulin dose. Actimetric sleep analysis showed an improvement in sleep fragmentation during closed-loop treatment. CONCLUSIONS Closed-loop therapy improved glycemic control above than did CSII + CGM in people with type 2 diabetes.

中文翻译：

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使用胰岛素泵治疗 2 型糖尿病患者的闭环胰岛素疗法：为期 12 周的多中心、开放标签随机、对照、交叉试验


目的 连续血糖监测 (CGM) 联合连续皮下胰岛素输注 (CSII) 对 2 型糖尿病患者的血糖控制效果优于多次注射治疗。闭环治疗的有效性需要在该人群中进一步评估。研究设计和方法 该研究的目的是测量混合闭环装置 (DBLG1) 与 CSII + CGM 相比对既往接受 CSII 治疗的 2 型糖尿病患者血糖控制的影响。这项随机、对照、交叉、两阶段、开放标签、多中心研究于 2022 年 8 月至 2023 年 7 月在 17 名受试者中进行（其中 9 名首先接受 6 周的 CSII + CGM，8 名接受 6 周的闭环治疗）先治疗）。主要终点是范围内的时间百分比（TIR：70-180 mg/dL）。次要结果是使用 1 周活动测定法客观测量的其他 CGM 血糖指标、体力活动和睡眠。结果 使用改良的意向治疗方法分析数据。平均年龄为 63 (SD 9) 岁，其中 35% 为女性。纳入时的平均 HbA1c 为 7.9% (SD 0.9)。在闭环条件下，TIR 增加到 76.0%（四分位距 69.0–84.0），而在 CSII + CGM 条件下，TIR 增加到 61.0%（四分位距 55.0–70.0）；平均差异为 15.0 个百分点（四分位数范围 8.0–22.0；P < 0.001）。次要终点的分析显示，超出范围的时间、血糖管理指标、血糖变异性均有所减少，并且每日胰岛素剂量有所增加。活动睡眠分析显示闭环治疗期间睡眠碎片化有所改善。结论 对于 2 型糖尿病患者，闭环疗法比 CSII + CGM 更能改善血糖控制。