Highlights the need for improved regulatory oversight as many marketed blood glucose meters fail to meet ISO accuracy standards despite FDA clearance.
In this issue of Journal of Diabetes Science and Technology, Christiansen and colleagues report results from two studies, laboratory and clinical, that assessed the accuracy of a new blood glucose monitoring system, the Contour®Next ONE (Ascensia Diabetes Care, Parsippany, NJ, USA). The new system comprises a blood glucose meter that can link (via Bluetooth®) to the Contour™ Diabetes app, which operates on a smartphone or tablet. Results from both studies showed that the system exceeded the accuracy standards defined by the International Organization for Standardization (ISO) 15197:2013. It is worrisome, however, that many FDA-cleared (and marketed) blood glucose monitoring systems do not meet ISO accuracy criteria. Significant improvements in regulatory oversight and enforcement are needed.
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Christopher G. Parkin (2017) studied this question.
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