Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz

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SHR Neuro Krebs Kardio Lipid Stoffw Microb

Mader, JK; Baumstark, A; Tüting, J; Sokol, G; Schuebel, R; Tong, Y; Roetschke, J; Slingerland, RJ.
Monitoring of the Analytical Performance of Four Different Blood Glucose Monitoring Systems: A Post-market Performance Follow-Up Study.
Diabetes Ther. 2024; 15(12):2525-2535 Doi: 10.1007/s13300-024-01665-9 [OPEN ACCESS]
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Führende Autor*innen der Med Uni Graz: Mader Julia
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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.
Find related publications in this database (Keywords): Blood glucose meter; Accuracy; ISO 15197; Food and Drug Administration; Post-market performance; Safety