Alwan Heba, Wilinska Malgorzata E, Ruan Yue, Da Silva Julien, Hovorka Roman
Wellcome-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.
J Diabetes Sci Technol. 2025 Mar;19(2):385-389. doi: 10.1177/19322968231185348. Epub 2023 Jul 8.
We analyzed real-world evidence to assess the performance of the mylife CamAPS FX hybrid closed-loop system.
Users from 15 countries across different age groups who used the system between May 9, 2022, and December 3, 2022, and who had ≥30 days of continuous glucose monitor data, and ≥30% of closed-loop usage were included in the current analysis (N = 1805).
Time in range (3.9-10 mmol/L) was 72.6 ± 11.5% (mean ± SD) for all users and increased by age from 66.9 ± 11.7% for users ≤6 years old to 81.8 ± 8.7% for users ≥65 years. Time spent in hypoglycemia (<3.9 mmol/L) was 2.3% [1.3, 3.6] (median [interquartile range]). Mean glucose and glucose management indicator were 8.4 ± 1.1 mmol/L and 6.9%, respectively. Time using closed-loop was high at 94.7% [90.0, 96.9].
Glycemic outcomes from the present real-world evidence are comparable to results obtained from previous randomized controlled studies and confirm the efficacy of this hybrid closed-loop system in real-world settings.
我们分析了真实世界证据，以评估mylife CamAPS FX混合闭环系统的性能。
纳入了来自15个国家、不同年龄组的用户，这些用户在2022年5月9日至2022年12月3日期间使用该系统，且有≥30天的连续血糖监测数据以及≥30%的闭环使用时间（N = 1805）。
所有用户的血糖在目标范围内（3.9 - 10 mmol/L）的时间为72.6 ± 11.5%（均值±标准差），且随年龄增长而增加，从≤6岁用户的66.9 ± 11.7%增至≥65岁用户的81.8 ± 8.7%。低血糖（<3.9 mmol/L）时间为2.3% [1.3, 3.6]（中位数[四分位间距]）。平均血糖和血糖管理指标分别为8.4 ± 1.1 mmol/L和6.9%。闭环使用时间较高，为94.7% [90.0, 96.9]。
目前真实世界证据中的血糖结果与先前随机对照研究的结果相当，并证实了这种混合闭环系统在真实世界环境中的有效性。
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