Original from: Medical Device Network
Astellas Pharma and Roche Diabetes Care Japan have signed an agreement to develop and commercialise the latter¡¯s Accu-Chek Guide Me blood glucose monitoring system as a combined medical product with BlueStar.
Developed by Welldoc, BlueStar is a US Food and Drug Administration (FDA)-approved mobile digital health solution for adult patients with type 1 or type 2 diabetes.
It is currently available in Canada and the US.
The solution provides personalised, artificial intelligence (AI)-driven digital coaching and insights to individuals, allowing them to self-manage their conditions and build better habits.
In Japan, Welldoc and Astellas will jointly develop BlueStar. Astellas intends to secure regulatory approval and reimbursement for the solution as a combined medical product in the future.
Being developed in Japan, the combined solution is intended to manage patients¡¯ diabetes by recording, storing and transmitting blood glucose data that is gathered from the Accu-Chek Guide Me system from Roche Diabetes Care.
It will also monitor medication, diet, activity and exercise in Welldoc¡¯s BlueStar app.
Additionally, the combined solution will help patients self-manage their diabetes with an algorithm designed using AI and customised digital coaching messages that will support the development of better habits over time.
Astellas will conduct the clinical trials for the combined medical product, which are planned to commence this year.
Astellas chief strategy officer Naoki Okamura said: ¡°Under our Corporate Strategic Plan 2021, ¡®Advance the Rx+ businesses¡¯ is one of the strategic goals Astellas is committed to.
¡°We hope that we can deliver greater VALUE to patients by expanding our partnership with Welldoc through BlueStar and connected insights with Roche Diabetes Care¡¯s glucose meters.¡±
The collaboration between Astellas, Roche Diabetes Care Japan and Welldoc aims to offer new treatment options and support to patients suffering from diabetes.
Source: Astellas and Roche partner on Bluestar integrated diabetes solution