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对CareSens Air CGM系统的手动和更新的可选校准算法的比较性能分析

Nina Jendrike¹, Manuel Eichenlaub¹, Manuela Link¹

¹Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.

Journal of diabetes science and technology

|July 3, 2025

概括

与之前的版本相比,更新的CareSens Air连续血糖监测 (CGM) 系统显示了更好的准确性和可靠性. 这种增强的CGM系统适用于糖尿病管理中的非辅助使用.

科学领域:

生物医学工程生物医学工程
医疗器械医疗器械
糖尿病技术技术

背景情况:

凯尔森斯空气持续血糖监测 (CGM) 系统 (CSAir) 最初需要手动校准,并有2小时的预热时间.
产品开发导致了更新的算法,将升温时间缩短到30分钟,并使校准成为可选的.

研究的目的:

为了比较CareSens Air CGM系统使用其原始手动校准算法的性能与更新的算法.
评估更新的CSAir系统的准确性,可靠性和用户满意度.

主要方法:

30名患有糖尿病的成年人参与了这项研究,每人佩戴3个CSAir传感器15天.
临床治疗包括频繁的毛细血管比较器测量和葡萄糖水平操纵.
使用平均绝对相对差异 (MARD) 和20/20协议率 (AR) 评估了准确性.

主要成果:

更新的算法表现出优异的准确性,20/20 AR和8.7%的MARD为93.9%,而手动算法则为90.1%和9.9%.
通过糖尿病技术协会错误网分析 (92.4%在A区的更新算法) 证实了高临床准确性.
该系统显示传感器的磨损时间很好,用户满意度很高,没有安全问题.

结论:

两种CSAir算法都可靠地运行,更新版本显示了更高的准确性.
凯尔森斯空气CGM系统,特别是更新的算法,适用于非辅助的糖尿病管理.

关键词:

准确度准确度准确度准确度算法算法是一种算法.不断监测葡萄糖的情况.非辅助性的使用.可选的校准测试是可选的业绩表现表现的表现表现是什么

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