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开源与商业自动化胰岛素输送系统用于1型糖尿病管理:来自加拿大的前性观察性比较研究
Zekai Wu1,2, Maha Lebbar2,3, Anne Bonhoure2,3
1Department of Medicine, Division of Experimental Medicine, McGill University, Montreal, Canada.
Diabetes technology & therapeutics
|March 18, 2025
概括
不受监管的开源自动化胰岛素输送 (AID) 系统在管理1型糖尿病方面与商业系统一样有效. 这两种系统都显示出安全性和可比的葡萄糖控制在现实世界中使用.
科学领域:
- 内分泌学 在内分泌学.
- 代谢疾病 代谢疾病
- 生物医学工程 生物医学工程
背景情况:
- 自动化胰岛素输送 (AID) 系统已经改变了1型糖尿病 (T1D) 的管理.
- 开源 (OS) AID系统提供了商业 (C-AID) 选项的替代方案.
- 对OS-AID与C-AID的真实世界比较数据对于临床指导至关重要.
研究的目的:
- 为了比较OS-AID和C-AID系统在患有T1D的成年人中的有效性和安全性.
- 评估葡萄糖管理,患者报告的结果 (PRO) 和安全性概况.
- 为了确定OS-AID系统是否与C-AID系统在范围内的时间 (TIR) 方面不劣.
主要方法:
- 一项为期12周的前性,观察性,比较性研究.
- 参与了78名T1D成年人使用AID系统至少3个月.
- 通过使用4周的盲目连续血糖监测数据来评估血糖控制.
主要成果:
- 在24小时TIR%方面,OS-AID系统与C-AID系统相比没有劣势 (78.3%与71.2%对比).
- 使用OS-AID的患者在低血糖症 (<3.9 mmol/L) 中经历了更长的时间,但是在推的范围内.
- 大多数PRO没有显著差异,在各组之间安全性和技术问题率相似.
结论:
- 在患有T1D的成年人中,OS-AID系统是安全的,并与TIR%的C-AID系统不逊色.
- 无论是OS-AID还是C-AID系统,都代表了T1D管理的可行选择.
- 现实世界的证据支持在临床实践中考虑OS-AID系统.
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