System Accuracy and Interference Evaluation of a New Glucose Dehydrogenase-Based Blood Glucose Meter for Patient Self-Testing.

IF 4.1 Q2 ENDOCRINOLOGY & METABOLISM

Journal of Diabetes Science and Technology Pub Date : 2025-03-01 Epub Date: 2023-10-02 DOI:10.1177/19322968231201862

Andreas Pfützner, Daiva Kalasauske, Mina Hanna, Daniela Sachsenheimer, Gerhard Raab, Silvia Weissenbacher, Nicole Thomé

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Abstract

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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用于患者自检的新型葡萄糖脱氢酶血糖仪的系统准确性和干扰评估。

新的欧洲医疗器械法规要求对血糖仪进行上市后监测评估。我们使用经批准的基于葡萄糖脱氢酶（GDH）的Wellion NEWTON BGM进行了符合ISO15197:2015的系统性能评估。100名受试者被纳入研究（44名女性，56名男性，43名健康受试者，23名1型糖尿病患者，34名2型糖尿病患者。年龄：53.7±15.8岁）。此外，使用经操作的肝素化全血进行实验室干扰试验，其中有十种选定物质（干扰定义：物质诱导的偏差>10%）。平均绝对相对差（MARD）为4.7%，100%的值分别位于一致误差网格的A区（99.7%）和B区（0.3%）。仅用木糖观察到干扰，木糖是基于GDH的BGM的已知干扰物质。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Diabetes Science and Technology Medicine-Internal Medicine

CiteScore

7.50

自引率

12.00%

发文量

148

期刊介绍： The Journal of Diabetes Science and Technology (JDST) is a bi-monthly, peer-reviewed scientific journal published by the Diabetes Technology Society. JDST covers scientific and clinical aspects of diabetes technology including glucose monitoring, insulin and metabolic peptide delivery, the artificial pancreas, digital health, precision medicine, social media, cybersecurity, software for modeling, physiologic monitoring, technology for managing obesity, and diagnostic tests of glycation. The journal also covers the development and use of mobile applications and wireless communication, as well as bioengineered tools such as MEMS, new biomaterials, and nanotechnology to develop new sensors. Articles in JDST cover both basic research and clinical applications of technologies being developed to help people with diabetes.