Ascensia Diabetes Care Receives CE Mark for the State-of-the-Art CONTOUR™ NEXT ONE and CONTOUR™ PLUS ONE Blood Glucose Monitoring Systems
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).
Notes for Editors
About Ascensia Diabetes Care
Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping improve the lives of people with diabetes by empowering them to take charge of their health. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a simple, positive, daily difference for people with diabetes.
Home to the world renowned CONTOURTM portfolio of blood glucose monitoring systems, our products combine advanced technology with user-friendly functionality that help people with diabetes to manage their condition. We are committed to continued research, innovation and development of new products. As a leader in diabetes care and a trusted partner, we collaborate closely with healthcare professionals and other partners to ensure our products meet the highest standards of accuracy and compliance.
Ascensia Diabetes Care was established in 2016 through the sale of Bayer Diabetes Care to Panasonic Healthcare Holdings Co., Ltd. Ascensia Diabetes Care products are sold in more than 125 countries. Following the close of the transaction in all countries, Ascensia Diabetes Care will have around 1,400 employees and operations in 38 countries.
For further information please visit the Ascensia Diabetes Care website at: http://www.ascensia.com .
CONTOUR™ is a registered trademark of Ascensia Diabetes Care Holdings AG.
1. International Organization for Standardization (2013). In vitro diagnostic test systems—requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
2. Christiansen et al. Poster presented at the 15th Annual Meeting of the Diabetes Technology Society, October 22-24, 2015, Bethesda, Maryland.
3. Bailey et al. Poster presented at the 15th Annual Meeting of the Diabetes Technology Society, October 22-24, 2015, Bethesda, Maryland.
Ascensia Diabetes Care
For further information please contact:
Tel: +44 (0)20 3727 1000
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