The clearance comes just a week after BlueStar received its 10th FDA clearance for using connected insulin dosing data in personalized bolus insulin dosing recommendations. Welldoc’s newest clearance enables BlueStar to provide bolus insulin dose recommendations based on continuous glucose readings.
BlueStar can now offer dose recommendations based on the most recent glucose reading and rate of change from a compatible CGM. This feature enhances BlueStar’s existing digital coaching capabilities for guiding dietary and lifestyle decisions in diabetes management.
Welldoc said in a news release that this makes it the first company to receive clearance for a CGM-informed bolus calculator of this kind. The company designed it for adults who manage diabetes with multiple daily injections (MDI) of insulin.
“This 11th 510(k) clearance is a remarkable achievement for Welldoc and demonstrates our steadfast commitment to transforming chronic care,” said Kevin McRaith, Welldoc president and CEO. “We are dedicated to creating new digital health capabilities which leverage the latest innovations like CGM to develop more connected and personalized solutions for individuals with complex health needs.”
Welldoc’s last FDA clearance for BlueStar — its ninth in total — expanded insulin dosing support to most types of insulin. That included bolus and premixed insulin titration for type 2 diabetes. That regulatory victory came in September 2021. Previous FDA clearances include in June 2020 when the FDA cleared the BlueStar Insulin Adjustment Program for basal insulin titration. It also holds clearances for advanced AI capabilities and enhanced product features.
More about the Welldoc BlueStar platform
BlueStar, the flagship product from Welldoc, guides individuals through their management of diabetes. It enables self-management of care while enhancing connections to the user’s healthcare team. Welldoc partners with health plans, systems and employers to extend care, improve health and reduce costs.
The platform utilizes AI to leverage health data to bring many dimensions of diabetes care into one platform.
Welldoc partners with health plans, systems and employers aiming to extend care, improve health and reduce costs. The company sees continued CGM adoption in the diabetes space as a way to enhance functionality with its own platform. It said this will help organizations who support diabetes populations provide extended management services and care.
“A device providing insulin therapy adjustments based on CGM inputs must meet specific requirements to be cleared under the 510(k) program, a higher bar than a calculator using blood glucose meter readings alone,” said Ian Cadieux, head of regulatory affairs at Welldoc. “The Welldoc team rose to the occasion, showcasing their capabilities to satisfy these special controls, which include demonstrating clinical validity, cybersecurity, useability and effective risk mitigation.”
