BlueStar's eighth FDA clearance adds long-acting basal insulin support for Type 2 patients

Healthcare providers use a web interface to prescribe an initial dose "and BlueStar does the rest," according to Welldoc's chief medical officer.
By Dave Muoio
02:51 pm

WellDoc's BlueStar chronic disease-management tool has picked up another 510(k) FDA clearance that will allow it to support adult Type 2 diabetes patients using long-acting basal insulin. The feature was announced by WellDoc this morning, but cleared by the agency in April, according to a listing on its website.

The new capability takes the form of a new program within the prescription BlueStar app, called the Insulin Adjustment Program. Healthcare providers use a web-based interface to prescribe an initial dose of long-acting basal insulin, which the new feature then uses to guide patients with subsequent titrations.

A representative from Welldoc told MobiHealthNews that the new feature can be turned on for any clients "within a few weeks," but that the company's commercialization plans won't kick off until Q4.


As the first mobile health product to secure reimbursement as a diabetes therapy, WellDoc's BlueStar has long been a go-to digital tool for chronic disease management. The platform already boasts a robust set of capabilities for Type 1 and Type 2 diabetes management – such as integration with a number of connect health-monitoring devices – and its eighth FDA clearance looks to similarly lighten the load on patients and providers alike.

“With BlueStar’s Insulin Adjustment Program, a provider prescribes a safe starting dose of insulin for the patient, and BlueStar does the rest,” Dr. Mansur Shomali, Welldoc’s chief medical officer, said in a statement. “The patient no longer has to wait to talk to his or her provider to adjust the insulin. The next time the patient meets with his or her health care provider, the insulin dose has been optimized and they can spend their visit focusing on other important elements of the patient’s care.”


WellDoc has released a steady stream of updates to its BlueStar platform since it launched 2013. Among the most recent was the addition of Type 1 diabetes management in November, and an integration with the Dexcom G6 continuous glucose monitor that allowed for data-driven glucose level insights in March.

On the business side of things, Welldoc struck a commercialization and development deal with Astellas Pharma late last year that would see the disease-management tool expand into East Asia. Not too long after, Express Scripts announced that BlueStar would be among the inaugural cohort of its digital health formulary.

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