Monitoring of the Analytical Performance of Four Different Blood Glucose Monitoring Systems: A Post-market Performance Follow-Up Study.

IF 3.8 3区医学 Q2 Medicine

Diabetes Therapy Pub Date : 2024-12-01 Epub Date: 2024-10-28 DOI:10.1007/s13300-024-01665-9

Julia K Mader, Annette Baumstark, Johannes Tüting, Günter Sokol, Ruth Schuebel, Yuhong Tong, Julia Roetschke, Robbert J Slingerland

{"title":"Monitoring of the Analytical Performance of Four Different Blood Glucose Monitoring Systems: A Post-market Performance Follow-Up Study.","authors":"Julia K Mader, Annette Baumstark, Johannes Tüting, Günter Sokol, Ruth Schuebel, Yuhong Tong, Julia Roetschke, Robbert J Slingerland","doi":"10.1007/s13300-024-01665-9","DOIUrl":null,"url":null,"abstract":"Introduction: A sizeable minority of commercially available blood glucose monitoring (BGM) systems fail to satisfy regulatory accuracy requirements, such as ISO 15197:2013, after approval. This study assessed whether the BGMs tested could consistently meet these ISO requirements by investigating their accuracy in a non-standardized setting.Methods: In this 18-month post-market performance study, using the ISO criteria, healthcare professionals tested the accuracy of four CE-marked BGM systems (Roche Diabetes Care, Mannheim, Germany) on European adults with diabetes mellitus. ISO criteria included 95% of blood glucose (BG) values being within ± 15 mg/dl of a reference measurement for BG < 100 mg/dl or ± 15% for BG ≥ 100 mg/dl and, in the Parkes Consensus Error grid for type 1 diabetes comparing capillary BGM measurements versus reference method, 99% of BG values falling within zone A (no effect on clinical action or outcome) and zone B (altered clinical action with little or no effect on clinical outcome).Results: BGM readings were obtained from 1650 participants, and the number of readings per BGM system was between 1712 and 2376. The percentage of BGM readings that fell within ISO 15197:2013 limits ranged from 99.4 to 99.9%. For all meter types, 100% of data points fell within zone A or zone B, and most data points for each meter (≥ 99.9%) were in zone A.Conclusion: All four CE-marked BGM models showed results within the accuracy limits defined by ISO 15197 in a non-standardized setting and thus consistently met regulatory accuracy requirements.","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2525-2535"},"PeriodicalIF":3.8000,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11561228/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diabetes Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s13300-024-01665-9","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/10/28 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"Medicine","Score":null,"Total":0}

引用次数: 0

Abstract

Introduction: A sizeable minority of commercially available blood glucose monitoring (BGM) systems fail to satisfy regulatory accuracy requirements, such as ISO 15197:2013, after approval. This study assessed whether the BGMs tested could consistently meet these ISO requirements by investigating their accuracy in a non-standardized setting.

Methods: In this 18-month post-market performance study, using the ISO criteria, healthcare professionals tested the accuracy of four CE-marked BGM systems (Roche Diabetes Care, Mannheim, Germany) on European adults with diabetes mellitus. ISO criteria included 95% of blood glucose (BG) values being within ± 15 mg/dl of a reference measurement for BG < 100 mg/dl or ± 15% for BG ≥ 100 mg/dl and, in the Parkes Consensus Error grid for type 1 diabetes comparing capillary BGM measurements versus reference method, 99% of BG values falling within zone A (no effect on clinical action or outcome) and zone B (altered clinical action with little or no effect on clinical outcome).

Results: BGM readings were obtained from 1650 participants, and the number of readings per BGM system was between 1712 and 2376. The percentage of BGM readings that fell within ISO 15197:2013 limits ranged from 99.4 to 99.9%. For all meter types, 100% of data points fell within zone A or zone B, and most data points for each meter (≥ 99.9%) were in zone A.

Conclusion: All four CE-marked BGM models showed results within the accuracy limits defined by ISO 15197 in a non-standardized setting and thus consistently met regulatory accuracy requirements.

查看原文本刊更多论文

监测四种不同血糖监测系统的分析性能：上市后性能跟踪研究。

导言：相当一部分市售血糖监测系统（BGM）在获得批准后无法满足 ISO 15197:2013 等法规对准确度的要求。本研究通过调查血糖监测系统在非标准化环境中的准确性，评估所测试的血糖监测系统能否始终满足 ISO 的这些要求：在这项为期 18 个月的上市后性能研究中，医护人员采用 ISO 标准对四款获得 CE 认证的 BGM 系统（罗氏糖尿病护理公司，德国曼海姆）的准确性进行了测试，测试对象为欧洲成年糖尿病患者。ISO 标准包括 95% 的血糖 (BG) 值在 BG 参考测量值的± 15 mg/dl 范围内：1650 名参与者获得了血糖仪读数，每个血糖仪系统的读数在 1712 到 2376 之间。符合 ISO 15197:2013 限制的血糖仪读数百分比从 99.4% 到 99.9% 不等。对于所有类型的仪表，100% 的数据点都位于 A 区或 B 区，每种仪表的大多数数据点（≥ 99.9%）都位于 A 区：结论：所有四种获得 CE 认证的 BGM 型号在非标准化环境下显示的结果都在 ISO 15197 规定的准确度范围内，因此始终符合法规对准确度的要求。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Diabetes Therapy Medicine-Endocrinology, Diabetes and Metabolism

CiteScore

6.90

自引率

7.90%

发文量

130

审稿时长

6 weeks

期刊介绍： Diabetes Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all areas of diabetes. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Diabetes Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.