Astellas Pharma Inc. said that it has reached an agreement with Roche Diabetes Care Japan Co., Ltd. for the development and commercialization of Roche Diabetes Care's Accu-Chek Guide Me blood glucose monitoring system with advanced accuracy as a combined medical product with BlueStar.
BlueStar is an FDA-cleared digital health solution for diabetes patients, developed by Welldoc Inc. and is currently marketed in the U.S. and Canada.
Astellas and Welldoc are jointly developing BlueStar in Japan. Astellas said it will aim to obtain regulatory approval and reimbursement as a combined medical product.
The combined medical product solution, which is being developed in Japan, is expected to support patients with managing their diabetes by capturing, storing, and transmitting blood glucose data which is obtained from Roche Diabetes Care's Accu-Chek Guide Me system and track medication, diet, activity and exercise in Welldoc's BlueStar(app).
It is also expected to support patients' diabetes self-management with a unique algorithm designed using AI, and personalized digital coaching messages, focused on building better habits over time.
Astellas said it is responsible for the clinical trials of the combined medical product, which are scheduled to start during 2023.
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