The US Food and Drug Administration (FDA) has granted 510(k) clearance to Ascencia Diabetes Care for the Contour®Next One Blood Glucose Monitoring System, according to a press release from the manufacturer.1
The Contour®Next One system includes a blood glucose smart meter, linked via Bluetooth to a patient’s mobile device. The meter is connected to the Contour™ Diabetes app, which collects, stores, and analyzes blood glucose measurements as they are delivered by the meter.
Research presented at the 15th Annual Meeting of the Diabetes Technology Society found that 95% of measurements made by the Contour®Next One were within ±8.4 mg/dL or ±8.4% of laboratory reference values for glucose concentrations less than 100 mg/dL or 100 mg/dL or greater, respectively.2
A smartLIGHT on the meter provides patient’s with instant blood glucose feedback, as well as reminders and alerts to encourage better diabetes management. An electronic logbook allows users to record meals, activities, and medication.
“This is an innovative new option for people living with diabetes,” said Robert Schumm, head of Ascencia Diabetes Care US. “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.”
The Contour®Next One system will be available throughout the US in early 2017. The Contour™ Diabetes app will be available for download for both iOS and Android devices.
- Ascensia diabetes care receives FDA clearance for the app-enabled Contour®Next One blood glucose monitoring system [news release]. Parsippany, NJ: Ascensia Diabetes Care. Published November 21, 2016. Accessed November 22, 2016.
- Christiansen M, et al. Accuracy and user performance evaluation of a new blood-glucose monitoring system in development for use with CONTOUR®NEXT test strips. Poster presented at : 15th Annual Meeting of the Diabetes Technology Society (DTS); October 22-24, 2015; Bethesda, MD.