Welldoc BlueStar app FDA Cleared to Integrate Retrospective CGM Data & Support Type 1 Diabetes – November 20, 2019

Goes live in December; Ten-month FDA review; CGM “daily insights” will integrate medication, food, activity coaching (focus on TIR); Dexcom CGM data via API/Apple Health

Welldoc announced that its BlueStar app has received FDA 510(k) clearance to add CGM integration and new features to support type 1 diabetes. The FDA review lasted ten months (listing here). The Agency has not posted the decision summary. We’re very excited to see this – we’ve been asking about type 1 for years, though certainly understand type 2 has been a much bigger priority to start.

The integration will go live next month and be offered in the same model as the type 2 diabetes version – through payers/employers (i.e., no direct-to-consumer option).

As noted earlier this year, this clearance enables BlueStar users to connect a CGM and “receive daily insights that integrate medication, food and activity coaching with their glucose data.” The screenshots below show a nice and very valuable focus on AGP and Time in Range! Insights will focus on patterns from the previous day and actions users can take to stay healthy – i.e., this is retrospective CGM data. BlueStar currently syncs with Dexcom’s API and Apple Health, and inclusion of other CGMs will require additional partnerships. (We hope to see all the CGM companies offer API and Apple Health integration, allowing companies like Welldoc to add value to the whole CGM ecosystem.) CGM data will also flow into BlueStar’s HCP-focused SMART Visit report.

For type 1 diabetes, Welldoc has added insulin on board (IOB) to its bolus calculator. Insulin doses will be calculated based on current glucose (integrated meter or manual entry), carbs, and insulin regimen; if there is IOB, the recommended dose will be decreased, just like pump bolus calculators. Over time, presumably BlueStar could read smart pen data and add CGM trend-based bolus calculation.

The BlueStar app on Apple iOS and Android does not appear to have be updated yet to reflect the clearance. Since the type 1 diabetes support includes a bolus calculator, it will require a prescription.

This expansion is a great move for Welldoc’s FDA-cleared BlueStar, which originally launched in 2014 as a prescribed app for people with type 2 diabetes using glucose meters. BlueStar’s key features – 25,000+ automated and personalized coaching messages, educational content, motivational support, and ability to chat with one’s care team – could help many with type 1 diabetes.

BlueStar App With CGM Integration



--by Adam Brown and Kelly Close