Blood Glucose Monitoring System Approved by FDA

Officials with Ascensia Diabetes Care have announced that the Contour Next One Blood Glucose Monitoring System has received FDA 510(k) clearance.

The system features a blood glucose smart meter that connects to the Contour Diabetes app, which will be available through both the Apple App store and Google Play. The app collects, stores, and analyzes patient blood glucose measurements.

Company officials tout the system’s accuracy, noting that the system has delivered 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 samples.¹

The system features include a smartLIGHT on the meter that provides feedback on blood glucose results, reminders and alerts to help support better management of diabetes, and an 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.

Reference

• Christiansen M. Poster presented at: 15th Annual Meeting of the Diabetes Technology Society (DTS); October 22-24, 2015; Bethesda, MD.