Welldoc Receives Ninth 510(k) for Award-Winning Diabetes Platform, BlueStar®

New clearance expands insulin management capabilities to include Bolus and Premixed Insulin titration

COLUMBIA, MD, Sept. 22, 2021 — Welldoc, a digital health leader revolutionizing chronic care, today announced the receipt of its ninth 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes platform, BlueStar®. The new clearance expands insulin dosing support to most types of insulin, including Bolus and Premixed Insulin titration for type 2 diabetes. In June 2020, Welldoc announced FDA clearance for the BlueStar Insulin Adjustment Program for basal insulin titration. Welldoc’s previous FDA clearances for its advanced Artificial Intelligence (AI) capabilities and enhanced product features support the company’s continued efforts to simplify complex diabetes management.

According to the Center for Disease Control (CDC), 2.9 million adults aged 20 years or older—nearly 11 percent of all US adults with diabetes—started using insulin within a year of their diagnosis. However, patients often face barriers to insulin acceptance, including fears of injection and hypoglycemia. Further, providers often lack the time and resources for proper diabetes education.¹ Due to the complexity of patient, provider and healthcare barriers, research indicates no single intervention is sufficient for diabetes and insulin management.²

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

Welldoc’s flagship product, BlueStar®, guides individuals through the complicated journey of living with diabetes by integrating personalized, real-time, and actionable insights into their daily lives, enabling improved health and outcomes. Welldoc’s advanced AI leverages the power of health data—medications, labs, diet, activity, symptoms, and psychosocial factors—and brings all the important dimensions of a patient’s care into one platform.

“Our platform is the first to holistically integrate complex insulin management and the many factors that influence a patient’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. “This clearance is yet another validation of the impact and significance of our digital health offering for those living with diabetes.”

About Welldoc
Welldoc®, a digital health leader revolutionizing chronic care, is integrating personalized, real-time and actionable insights into the daily lives of individuals living with chronic conditions, enabling improved health and outcomes. Welldoc’s comprehensive chronic care platform provides multi-condition support across diabetes, hypertension, heart failure and behavioral health. Welldoc’s flagship product, BlueStar®, an FDA-cleared digital health solution, guides individuals through the complicated journey of living with diabetes by enabling them to self-manage their care while enhancing connections to their healthcare team. Welldoc partners with health plans, health systems and employers with the goal of extending care, improving health and reducing costs.

¹Aschner, Pablo MD, MSc* Insulin Therapy in Type 2 Diabetes, American Journal of Therapeutics: January/February 2020 – Volume 27 – Issue 1 – p e79-e90 doi: 10.1097/MJT.0000000000001088
²Okemah J, Peng J, Quiñones M. Addressing Clinical Inertia in Type 2 Diabetes Mellitus: A Review. Adv Ther. 2018;35(11):1735-1745. doi:10.1007/s12325-018-0819-5

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