The US Food and Drug Administration (FDA) has granted two new clearances to Welldoc's BlueStar digital health platform to enable personalized insulin dosing recommendations for people with type 1 or type 2 diabetes.
The latest clearance, announced on August 23, enables the app-based platform to provide bolus insulin dose recommendations that are based on glucose and trend data from a compatible continuous glucose monitoring (CGM) device. On August 15, the FDA cleared the BlueStar to use connected insulin dosing data in personalized bolus insulin dosing recommendations.
"Welldoc is the first company to receive clearance for a CGM-informed bolus calculator specifically designed for adults who manage their diabetes with multiple daily injections of insulin," according to a company statement.
"With this clearance, Welldoc is filling a significant gap for people who require complex insulin regimens. By connecting directly with CGM data and using both glucose values and trend arrows, the BlueStar solution will provide precise and in-the-moment insulin dosing guidance directly to individuals, helping them reach their glucose targets," said endocrinologist Grazia Aleppo, of the Feinberg School of Medicine at Northwestern University, Chicago, in the statement.
The new features extend the platform's existing digital diet and lifestyle coaching capabilities. Previous FDA clearances included expansions to use most types of available insulins, including bolus and premixed insulin titration for patients with type 2 diabetes, in September 2021 and for basal insulin adjustment in June 2020.
Aleppo was a principal investigator in Welldoc's clinical validation study for BlueStar.
Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape. Other work of hers has appeared in the Washington Post, NPR's Shots blog, and Diabetes Forecast magazine. She can be found on Twitter @MiriamETucker.
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Cite this: FDA Clears New Capabilities for Diabetes App BlueStar - Medscape - Aug 30, 2023.