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PARSIPPANY, N.J. — Ascensia Diabetes Care has gained Food and Drug Administration 510(k) clearance for its Contour Next One blood glucose monitoring system.
Ascensia said the approval marks a key step in making the Contour Next One available to Americans with diabetes. The company expects to release the product in the United States early next year.
The Contour Next One system features a user-friendly blood glucose smart meter that links to a mobile device via Bluetooth connectivity. The meter connects to the Contour Diabetes mobile app, which collects, stores and analyzes the user’s blood glucose measurements delivered to it by the meter. The measurements can then be used to identify patterns and trends that may help patients understand how their daily activities affect their glucose levels.
Features include a smartLIGHT on the meter, which provides instant feedback on blood glucose results, as well as reminders and alerts to help support better management of diabetes. An electronic logbook also enables users to record events such as meals, activities and medication.
In addition, users can set up an optional secure online, cloud-based account for the management and storage of their data. They also can email PDF summary reports to their caregiver or health care professional.
Ascensia noted that the Contour Next One is its most accurate system yet, with 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.
“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,” stated Robert Schumm, head of Ascensia Diabetes Care US.
“We believe the future of health care 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,” Schumm added. “Today, fewer than 2% 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.”
The Contour Diabetes app will be available for download from the Apple App Store (iOS) and Google Play (Android).
