Accuracy of Two CE-Marked Blood Glucose Monitoring System Based on EN ISO 15197:2015

Abstract

Blood glucose monitoring systems (BGMS) are essential for the management of diabetic patients. Although International Organization for Standardization (ISO) 15197:2015 criteria require rigorous monitoring of BGMS devices before commercialization, manufacturing quality standards may decline after FDA or EU approval. This work aimed to demonstrate the accuracy and precision of two BGMS devices currently available on the market. A laboratory study was conducted from June to August 2021 using two BGMS devices. One hundred samples were collected and evaluated according to ISO 15197:2015 guidelines. Over 95% accuracy was achieved by both devices using stricter ISO criteria (at least 95% of values within ±10 mg/dL or ±10% of the results of the reference measurement procedure). Analysis of the error grid showed that 99.5% of the results were in zone A. Surveillance of the accuracy and precision of BGMS devices after FDA and EU approval is an essential procedure to help patients and physicians manage glycemia and determine an appropriate outcome and personalized approach to diabetes treatment.