Real-World Evidence Analysis of a Hybrid Closed-Loop System.

IF 4.1 Q2 ENDOCRINOLOGY & METABOLISM

Journal of Diabetes Science and Technology Pub Date : 2025-03-01 Epub Date: 2023-07-08 DOI:10.1177/19322968231185348

Heba Alwan, Malgorzata E Wilinska, Yue Ruan, Julien Da Silva, Roman Hovorka

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引用次数: 0

Abstract

Background: We analyzed real-world evidence to assess the performance of the mylife CamAPS FX hybrid closed-loop system.

Methods: 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).

Results: 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].

Conclusions: 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.

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混合闭环系统的实证分析

背景我们分析了真实世界的证据，以评估 mylife CamAPS FX 混合闭环系统的性能：来自 15 个国家不同年龄段的用户在 2022 年 5 月 9 日至 2022 年 12 月 3 日期间使用了该系统，且连续血糖监测数据≥30 天，闭环使用率≥30%：所有用户在血糖范围（3.9-10 mmol/L）内的时间为 72.6 ± 11.5%（平均 ± 标准差），随着年龄的增长，≤6 岁的用户为 66.9 ± 11.7%，≥65 岁的用户为 81.8 ± 8.7%。低血糖时间（结论：本真实世界证据的血糖结果与之前随机对照研究的结果相当，证实了这种混合闭环系统在真实世界环境中的有效性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Diabetes Science and Technology Medicine-Internal Medicine

CiteScore

7.50

自引率

12.00%

发文量

148

期刊介绍： The Journal of Diabetes Science and Technology (JDST) is a bi-monthly, peer-reviewed scientific journal published by the Diabetes Technology Society. JDST covers scientific and clinical aspects of diabetes technology including glucose monitoring, insulin and metabolic peptide delivery, the artificial pancreas, digital health, precision medicine, social media, cybersecurity, software for modeling, physiologic monitoring, technology for managing obesity, and diagnostic tests of glycation. The journal also covers the development and use of mobile applications and wireless communication, as well as bioengineered tools such as MEMS, new biomaterials, and nanotechnology to develop new sensors. Articles in JDST cover both basic research and clinical applications of technologies being developed to help people with diabetes.