Type of information: Development agreement
Compound: insulin management solutions.
Company: Ascensia Diabetes Care (Switzerland) Voluntis (France)
Therapeutic area: Metabolic diseases
Type agreement: development
Action mechanism: Insulia® Diabetes Management Companion is a prescription-only medical device that provides people with type 2 diabetes with insulin dose recommendations and educational coaching messages, through a smartphone app, based on blood glucose values and other diabetes-related data. Insulia® supports a wide variety of treatment plan configurations and evidence-based insulin adjustment rules used in routine clinical practice. The personalized treatment plan is initially set-up by the healthcare professional, based on an individual's profile, insulin prescription and blood glucose targets. The dose adjustment algorithm is embedded in the app requiring no further validation from healthcare professionals after the system's initial setup. The patient data can then be automatically shared with the healthcare team, who can remotely monitor the patient's progress toward their goal thanks to tailored notifications. The solution has received both FDA 510(k) clearance from the US FDA and CE Mark approval in Europe in November 2016. The Contour®Next One and Contour® Plus One systems each feature a highly accurate easy-to-use blood glucose smart meter that links to a 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 delivered to it by the meter. The Contour®Next One and Contour® Plus One BGMSs received CE Mark approval in Europe in April 2016, and the Contour® Next One BGMS received 510(k) clearance from the FDA in November 2016.
Disease: type 2 diabetes