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新型基于葡萄糖脱酶的血糖计的系统准确性和干扰评估,用于患者自我测试

Andreas Pfützner^1,2,3,4, Daiva Kalasauske¹, Mina Hanna¹

¹Pfützner Science & Health Institute, Mainz, Germany.

Journal of diabetes science and technology

|October 3, 2023

概括

威利恩·纽顿血糖计 (BGM) 符合ISO15197:2015标准,在营销后监测中表现出色. 这种葡萄糖测试系统表现出高精度和最小干扰,确保糖尿病患者可靠的血糖监测.

科学领域:

医疗器械医疗器械
临床诊断临床诊断临床诊断
内分泌学在内分泌学.

背景情况:

欧洲医疗器械法规要求对血糖计 (BGM) 进行营销后监测.
ISO15197:2015为BGM系统评估提供了性能标准.
基于葡萄糖脱酶 (GDH) 的BGM需要仔细评估,因为可能会产生干扰.

研究的目的:

根据ISO15197:2015.15的标准来评估Wellion NEWTON BGM的系统性能.
在不同受试者群体中评估BGM的准确性和可靠性.
为了确定与常见物质的任何潜在干扰.

主要方法:

符合ISO15197:2015的系统性能评估.
招募了100名受试者 (健康,1型糖尿病,2型糖尿病).
通过使用操纵的血液样本对十种选定物质进行了实验室干扰测试.

主要成果:

平均绝对相对差异 (MARD) 为4.7%.
100%的结果属于共识错误网格区域A (99.7%) 和B (0.3%).
仅与已知基于GDH的BGM干扰剂西洛斯 (xylose) 发现干扰.

结论:

威利恩·纽顿BGM系统符合ISO15197:2015.15的严格性能要求.
在血糖监测方面,BGM表现出高准确度和可靠性.
克西洛斯干扰是基于GDH的系统的已知限制,并得到证实.

关键词:

血糖计可以测量血糖.葡萄糖脱水酶的使用干扰干扰是干扰的患者进行自我检测.

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