Key result
Two CE-marked blood glucose monitoring systems achieved over 95% accuracy using strict ISO 15197:2015 criteria, with 99.5% of results falling in zone A of the error grid.
Why the study?
Manufacturing quality standards for blood glucose monitoring systems may decline after FDA or EU approval, necessitating evaluation of device accuracy and precision.
Are two commercially available CE-marked blood glucose monitoring systems accurate and precise according to ISO 15197:2015 criteria?
Observational (n=100)
Are two commercially available CE-marked blood glucose monitoring systems accurate and precise according to ISO 15197:2015 criteria?
Two commercially available CE-marked blood glucose monitoring systems demonstrated high accuracy and precision, meeting strict ISO 15197:2015 criteria.
Supports accuracy of these CE-marked systems; leaves open broader validation across populations.
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.
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Kim et al. (2021) conducted an observational in Diabetes (n=100). Two CE-Marked Blood Glucose Monitoring Systems vs. Reference measurement procedure was evaluated on Accuracy according to ISO 15197:2015 criteria (values within ±10 mg/dL or ±10% of reference). Two CE-marked blood glucose monitoring systems achieved over 95% accuracy using strict ISO 15197:2015 criteria, with 99.5% of results falling in zone A of the error grid.
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