葡萄糖计
2型糖尿病
糖尿病
血糖监测
医学
血糖自我监测
干扰(通信)
内科学
1型糖尿病
内分泌学
计算机科学
连续血糖监测
计算机网络
频道(广播)
作者
Andreas Pfützner,Daiva Kalasauske,Mina Hanna,Daniela Sachsenheimer,Gerhard Raab,Stefan Weissenbacher,Nicole Thomé
标识
DOI:10.1177/19322968231201862
摘要
New European medical device regulations require the performance of postmarketing surveillance evaluations for blood glucose meters (BGMs). We conducted an ISO15197:2015-conform system performance evaluation with the approved glucose dehydrogenase (GDH)-based Wellion NEWTON BGM. One hundred subjects were enrolled into the study (44 female, 56 male, 43 healthy subjects, 23 type 1 diabetes, 34 type 2 diabetes, age: 53.7 ± 15.8 years). In addition, manipulated heparinized whole blood was used for a laboratory interference test with ten selected substances (interference definition: substance-induced bias > 10%). The mean absolute relative difference (MARD) was 4.7%, and 100% of the values were in zones A (99.7%) and B (0.3%), respectively, of the consensus error grid. Interference was observed with xylose only, which is a known interfering substance for GDH-based BGMs.
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