Basel, Switzerland, 17 May 2016 – Today, Ascensia Diabetes Care announced that it has received CE Mark (Conformité Européenne) for the new CONTOUR™ NEXT ONE and CONTOUR™ PLUS ONE blood glucose monitoring systems, the next exciting development in the evolution of self-monitoring of blood glucose for people with diabetes.
The CONTOUR™ NEXT ONE and CONTOUR™ PLUS ONE systems feature an easy-to-use wireless-enabled blood glucose smart meter that links to a smart 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 received from the meter. Blood glucose results can be analyzed for patterns and trends that may help patients understand how certain aspects of their daily activities affect their blood glucose.
Michael Kloss, CEO, Ascensia Diabetes Care, said: “We believe that the CONTOUR™ NEXT ONE and CONTOUR™ PLUS ONE blood glucose monitoring systems can be a significant advance for people with diabetes. These systems combine the remarkable accuracy of our CONTOUR™ NEXT and CONTOUR™ PLUS meter platforms with the easy-to-use features of the CONTOUR™ Diabetes App to provide insights that help patients to better manage their condition. These systems enable people with diabetes to learn more about their condition and make the appropriate management decisions.”
He added: “This approval will allow us to start bringing these innovative solutions to the patients that need them in Europe. As the first product approval for Ascensia Diabetes Care this demonstrates our commitment to empowering people living with diabetes through our innovative solutions. This is our first step to enabling continuous care and helping patients to manage diabetes, smarter.”
The CONTOUR™ NEXT ONE and CONTOUR™ PLUS ONE meters have been demonstrated to be two of the most accurate systems that have been developed by Ascensia Diabetes Care to date. Both meters have shown remarkable accuracy that exceeds the ISO 15197:2013 accuracy criteria1 in the laboratory and clinical setting.2,3 In a clinical study for CONTOUR™ NEXT ONE, 95% of meter results were within 8.4 mg/dL or 8.4% of the reference result for subject fingertip tests.2 In a similar CONTOUR™ PLUS ONE clinical study, 95% of meter results were within 8.5 mg/dL or 8.5% of the reference result for subject fingertip tests.3
Features of the system include a smart light on the meter that gives instant feedback on blood glucose results, reminders and alerts to help support better management of diabetes, and an extensive electronic logbook that records events such as meals, activities and medication. Users can set-up an optional cloud account for management and storage of data and have the ability to email PDF summary reports to their healthcare professionals for discussion. This system will also continue to evolve in the future bringing new features to help people with diabetes manage their condition.
Now that Ascensia Diabetes Care has received the CE Mark for both meters and the CONTOUR™ Diabetes App, they will be launched initially in two European markets and later in 2016 across further European countries. CONTOUR™ NEXT ONE will be launched in countries where the CONTOUR™ NEXT test strips are already available and CONTOUR™ PLUS ONE will be launched where the CONTOUR™ PLUS test strips are available. The CONTOUR™ Diabetes App will be available in the Apple App Store (iOS) and Google Play (Android).