联合胰岛素输送和葡萄糖传感器系统的可行性研究,该传感器系统在1型糖尿病患者身上佩戴了7天
Hannah Cunningham1, John Apostolopoulos1, Jennifer Ngan1
1Department of Medicine, St Vincent's Hospital Melbourne, The University of Melbourne, Fitzroy, Victoria, Australia.
Diabetes, obesity & metabolism
|November 25, 2025
概括
这项研究评估了一种用于1型糖尿病 (T1D) 管理的新型持续血糖监测和胰岛素输送装置 (CGM-IS). 虽然传感器的准确性是可以接受的,但在3天后出现了胰岛素输送问题,需要在商业化之前进一步改进.
科学领域:
- 内分泌学 在内分泌学.
- 生物医学工程 生物医学工程
- 糖尿病 技术 技术
背景情况:
- 1型糖尿病 (T1D) 的管理需要精确的葡萄糖监测和及时的胰岛素输送.
- 综合连续血糖监测和胰岛素输送系统 (CGM-IS) 提供了改善血糖控制的潜力.
- 评估新型集成设备的实际性能对于临床采用至关重要.
研究的目的:
- 评估新型CGM-IS装置在T1D成年人7天佩戴期间的传感器准确性和胰岛素输送完整性.
- 确定为集成的CGM和胰岛素输送系统的7天佩戴协议的可行性.
- 确定需要改善设备耐用性和性能的领域.
主要方法:
- 一个单中心,单臂,非随机研究,涉及40名T1D成年人.
- 参与者使用CGM-IS设备7天,包括3天的饮食测试日和4天的自由生活日.
- 主要终点包括传感器精度 (MARD) 和输液组合功能 (TIR,平均BG,TDD).
主要成果:
- 传感器平均相对差异 (MARD) 在穿戴日间从14.8%到17.7%不等.
- 胰岛素输送完整性维持到第3天,随后增加了每日总剂量 (TDD) 和平均血糖 (BG).
- 射程时间 (TIR) 在5-6天下降了7.8%,92.1%的设备持续了超过4天.
结论:
- 该CGM-IS装置显示了在T1D中使用长达7天的潜力,平均存活时间超过6天.
- 胰岛素输送的耐用性和传感器性能需要进一步优化,以实现商业可行性.
- 这项可行性研究为开发下一代综合糖尿病管理系统提供了宝贵的见解.
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