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Welldoc’s BlueStar digital health platform has received two new clearances from the US Food and Drug Administration (FDA), allowing it to offer personalized insulin dosing recommendations for individuals with type 1 or type 2 diabetes.
The most recent clearance, announced on August 23rd, empowers the app-based platform to furnish bolus insulin dose recommendations based on glucose and trend data from a compatible continuous glucose monitoring (CGM) device. On August 15th, the FDA granted clearance for BlueStar to incorporate connected insulin dosing data into personalized bolus insulin dosing recommendations.
Welldoc stands as the pioneering company to attain clearance for a CGM-informed bolus calculator tailored specifically for adults managing diabetes through multiple daily injections of insulin, as stated by the company.
Grazia Aleppo, an endocrinologist at the Feinberg School of Medicine at Northwestern University, Chicago, noted in the statement that this clearance fills a significant void for individuals requiring complex insulin regimens. By directly interfacing with CGM data and leveraging both glucose values and trend indicators, the BlueStar solution will offer precise and real-time insulin dosing guidance, thereby assisting individuals in achieving their glucose targets.
These novel features build upon the platform’s existing capabilities for digital diet and lifestyle coaching. Previous FDA clearances encompassed expansions to incorporate a wide range of available insulins, including bolus and premixed insulin titration for patients with type 2 diabetes in September 2021, and basal insulin adjustment in June 2020.
Grazia Aleppo served as a principal investigator in Welldoc’s clinical validation study for BlueStar.
Source Medscape.
