OBJECTIVE To determine feasibility and compare acceptance of an investigational Medtronic enhanced Advanced Hybrid Closed Loop (e-AHCL) system in adults with type 1 diabetes with earlier iterations. RESEARCH DESIGN AND METHODS Nonrandomized three-stage (12 weeks each) exploratory study comparing e-AHCL (Bluetooth-enabled MiniMed 780G insulin pump with automatic data upload [780G] incorporating an updated algorithm; calibration-free all-in-one disposable sensor; 7-day infusion set) preceded by a run-in (non-Bluetooth 780G [670G V4.0 insulin pump] requiring manual data upload; Guardian Sensor 3 [GS3] requiring calibration; 3-day infusion set), stage 1 (780G; GS3; 3-day infusion set), and stage 2 (780G; calibration-free Guardian Sensor 4; 3-day infusion set). Treatment satisfaction was assessed by Diabetes Technology Questionnaire (DTQ)-current (primary outcome) and other validated treatment satisfaction tools with glucose outcomes by continuous glucose monitoring metrics. RESULTS Twenty-one of 22 (11 women) participants (baseline HbA1c 6.7%/50 mmol/mol) completed the study. DTQ-current scores favored e-AHCL (123.1 [17.8]) versus run-in (101.6 [24.2]) and versus stage 1 (110.6 [20.8]) (both P < 0.001) but did not differ from stage 2 (119.4 [16.0]; P = 0.271). Diabetes Medication System Rating Questionnaire short-form scores for “Convenience and Efficacy” favored e-AHCL over run-in and all stages. Percent time in range 70–180 mg/dL was greater with e-AHCL versus run-in and stage 2 (+2.9% and +3.6%, respectively; both P < 0.001). Percent times of <70 mg/dL for e-AHCL were significantly lower than run-in, stage 1, and stage 2 (−0.9%, −0.6%, and −0.5%, respectively; all P < 0.01). CONCLUSIONS e-AHCL was feasible. User satisfaction increased compared with earlier Medtronic HCL iterations without compromising glucose control.

中文翻译：

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利用美敦力研究增强型高级混合闭环系统 (e-AHCL) 提高满意度，同时保持安全性和高航程时间 (TIR)

目的 确定美敦力 (Medtronic) 增强型高级混合闭环 (e-AHCL) 系统在成人 1 型糖尿病患者中的可行性并比较其接受度与早期迭代。研究设计和方法非随机三阶段（每阶段 12 周）探索性研究比较 e-AHCL（支持蓝牙的 MiniMed 780G 胰岛素泵，具有自动数据上传 [780G]，并结合了更新的算法；免校准一体式一次性传感器； 7 天输液器），然后是磨合（非蓝牙 780G [670G V4.0 胰岛素泵]，需要手动数据上传；Guardian Sensor 3 [GS3] 需要校准；3 天输液器），第 1 阶段（780G ；GS3；3 天输液器）和第 2 阶段（780G；免校准 Guardian Sensor 4；3 天输液器）。治疗满意度通过当前糖尿病技术问卷（DTQ）（主要结果）和其他经过验证的治疗满意度工具以及通过连续血糖监测指标的血糖结果进行评估。结果 22 名参与者（11 名女性）中的 21 名（基线 HbA1c 6.7%/50 mmol/mol）完成了研究。与磨合期 (101.6 [24.2]) 和第 1 阶段 (110.6 [20.8]) 相比，DTQ 当前得分更倾向于 e-AHCL (123.1 [17.8])（均 P < 0.001），但与第 2 阶段 (119.4) 没有差异[16.0]；P = 0.271）。糖尿病药物系统评级调查问卷的“便利性和有效性”的简短分数比磨合阶段和所有阶段都更倾向于 e-AHCL。e-AHCL 与磨合期和第 2 阶段相比，70–180 mg/dL 范围内的时间百分比更高（分别为 +2.9% 和 +3.6%；均 P < 0.001）。e-AHCL <70 mg/dL 的百分比时间显着低于磨合期、第 1 阶段和第 2 阶段（分别为 -0.9%、-0.6% 和 -0.5%；所有 P < 0.01）。结论 e-AHCL 是可行的。与早期的美敦力 HCL 迭代相比，用户满意度有所提高，且不影响血糖控制。