A Novo Nordisk-supported study reveals that the MyGlucoHealth blood glucose monitorr failed to meet regulatory standards and in fact, may actually overestimate values in the hypoglycemic range. Hannah Dellabella of Endocrinology Advisor reports that in randomized clinical trials the device dialed to meet the analytical accuracy level required by International Organization for Standardization (ISO) 15197:2015 or Food and Drug Administration (FDA) guidelines according to results published recently in the Journal of Diabetes Science and Technology.
The study included 10 of 3088 glucose meters and 6 of 23 strip lots used in the randomized clinical trials. Follow the link here for the original source.
Filiz Demircik, PhD
Valeria Kirsch, BScSource: Endocrinologyadvisor