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FDA Grants Clearance for New App-Enabled Blood Glucose Monitoring System

The U.S. Food and Drug Administration (FDA) last week granted 510(k) clearance for a new app-enabled blood glucose monitoring system. Ascensia Diabetes Care The device will be marketed as the CONTOUR® NEXT ONE Blood Glucose Monitoring System (BGMS)  by Ascencia Diabetes Care.

The CONTOUR NEXT ONE system features an blood glucose smart meter that links to a mobile device via Bluetooth®connectivity. The meter connects to the CONTOUR™ DIABETES app, a mobile app that collects, stores, and analyzes patient blood glucose measurements delivered to it by the meter.

Robert Schumm, head of Ascensia Diabetes Care US, says: “This is an innovative new option for people living with diabetes. The system combines the remarkable accuracy of the CONTOUR NEXT ONE meter with the easy-to-use features of the CONTOUR DIABETES app and is designed to provide insights that may help people manage their diabetes in a better way.”

He adds: “We believe the future of healthcare lies in connecting points of care. The first step in that journey for diabetes is to provide a connected system which can add value for people living with diabetes. Today, fewer than two percent of people living with diabetes use a connected meter. CONTOUR NEXT ONE is designed to be simple-to-use, and can meet the needs of a broad group of users. The FDA clearance paves the way to providing this option for all those who may benefit from it.”

Ascensia Diabetes Care expects to make the CONTOUR NEXT ONE system available in the U.S. in early 2017. The CONTOUR DIABETES app will be available for download from the Apple App Store (iOS) and Google Play (Android). Ascensia Diabetes Care says CONTOUR NEXT ONE is the most accurate system they’ve developed.  The device was shown to deliver  95% of results within ±8.4 mg/dL or ±8.4% of the laboratory reference values for glucose concentrations < 100 mg/dL or ≥ 100 mg/dL, respectively, when tested via subject obtained fingerstick results.1

The system also features include a smartLIGHT on the meter which provides instant feedback on blood glucose results, reminders, and alerts to help support better management of diabetes, and a simple but thorough electronic logbook where an individual can record events such as meals, activities and medication. Users can set up an optional secure online, cloud-based account for the management and storage of their data, and have the ability to email PDF summary reports to their caregiver or healthcare professional for discussion.