Welldoc’s Bluestar lands FDA clearance for expanded insulin dosing support


Digital chronic care company Welldoc has received its ninth FDA 510(k) clearance for its diabetes management platform BlueStar. 

The new clearance, which was announced by Welldoc Wednesday, but approved by the FDA earlier this month, expands its earlier approval for insulin dosing support to include bolus and premixed insulin titration for Type 2 diabetes.

The Insulin Adjustment Program with basal insulin support was announced in June last year and approved by the FDA in April.

“Our platform holistically integrates complex insulin management and the many factors that influence a person’s health. By translating the best of medical science into a digital health solution, clinicians will be able to manage insulin adjustment in a safe, effective, and efficient manner, while simultaneously caring for the whole person,” Kevin McRaith, president and CEO of Welldoc, said in a statement.

“This clearance is yet another validation of the impact and significance of our digital health offering for those living with diabetes.”


Nearly 27 million people of all ages in the U.S. had diagnosed diabetes in 2018, according to the Centers for Disease Control and Prevention’s 2020 national statistics report. Nearly three million adults age 20 or older – nearly 11% of all U.S. adults with diagnosed diabetes – started using insulin within a year of their diagnosis.

A study published in Clinical Diabetes in 2016 found errors in self-administering insulin, including using the wrong dosage, were common. 

“Insulin dosing is a constant challenge for people with diabetes and their care teams,” Welldoc’s Chief Medical Officer Dr. Mansur Shomali said in a statement.

“Our new bolus and premixed insulin titration offering will help clinicians optimize insulin management and reduce the burden of care coordination. The program’s comprehensive solutions will ensure individuals are more confident in their insulin dosing, while also enhancing crucial connections to their care teams.”


Earlier this year, Welldoc announced it was teaming up with pharma company Eli Lilly to use Welldoc software in Lilly’s connected insulin products. 

In 2020, Welldoc and Dexcom collaborated to integrate BlueStar with the G6 continuing glucose monitor. The companies signed their initial data partnership agreement in 2019. 

The company also added digital behavioral health tools to its platform late last year, including improving problem solving, developing social skills, aiding sleep and reducing anxiety. 

Other players in the digital diabetes management space include Glooko, Steady Health, which was recently acquired by Carbon Health, and 9am.health, which launched earlier this week. 



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