对混合闭环系统的现实世界证据分析
Heba Alwan1,2, Malgorzata E Wilinska1, Yue Ruan1
1Wellcome-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Journal of diabetes science and technology
|July 8, 2023
概括
mylife CamAPS FX混合闭环系统在现实世界使用中证明了有效的葡萄糖控制. 现实世界的数据显示,血糖结果与临床试验相似,证实了系统在不同用户的有效性.
科学领域:
- 内分泌学 在内分泌学.
- 医疗技术 医疗技术 医学技术
- 糖尿病管理 糖尿病管理
背景情况:
- 关于mylife CamAPS FX混合闭环系统的真实世界证据 (RWE) 分析.
- 在一个大规模的国际用户群体中评估系统性能.
研究的目的:
- 为了评估mylife CamAPS FX混合闭环系统的现实世界的有效性.
- 使用该系统,在多样化的人口中比较血糖结果.
主要方法:
- 分析了来自15个国家的1805名用户的RWE.
- 纳入标准:≥30天的连续血糖监测 (CGM) 数据和≥30%的闭环使用.
- 在2022年5月9日至2022年12月3日期间收集的数据.
主要成果:
- 平均时间在范围 (TIR) 72.6% (3.9-10 mmol/L),随着年龄的增长.
- 低血糖的低时间 (<3.9 mmol/L) 在2.3%.
- 闭环系统的高使用率为94.7%.
结论:
- 现实世界的血糖结果与随机对照试验可比.
- mylife CamAPS FX系统在现实世界糖尿病管理中表现出有效性.
- 证实了混合闭环技术在不同人群中的有效性.
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