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Welldoc’s BlueStar: an innovative tool for the self-management of diabetes

September 7, 2023

What’s new in continuous glucose monitoring devices?

Welldoc’s flagship product, BlueStar, received its 11th FDA 510(k) clearance last month. This latest clearance allows the digital health platform to deliver personalized bolus insulin dosing recommendations based on glucose trend data from a compatible real-time, continuous glucose monitoring (RT-CGM) device. The system was previously cleared for basal insulin adjustment and for use with most types of available insulins, including bolus and premixed insulin titration for patients with type 2 diabetes (T2D). (Whooley, 2023)

According to its news release, Welldoc is 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. (Welldoc, 2023)

What’s the potential patient impact?

According to the CDC, 37.3 million Americans – about one in ten – have diabetes. The eighth leading cause of death in the United States, diabetes is responsible for an estimated $327 billion in medical costs and lost work and wages. Management of the disease is complex and involves a careful balance of medications, glucose monitoring, activity, and diet. The American Diabetes Association’s 2023 Standards of Care in Diabetes recommends the use of digital health technology solutions, including CGMs, in treating diabetes for some individuals. (ADA, 2023)

How does it work?

The BlueStar digital health solution, intended for use in patients 18 and older with type 1 or T2D, incorporates glucose data from multiple devices and generates coaching messages using artificial intelligence to aid in diabetes self-management. The software can be used on mobile phones or personal computers. (Welldoc, 2023; Kumbara, 2023)

What’s the evidence?

Findings from a recent real-world study of the BlueStar system and its effect on glycemic control and participant engagement with the program were published in JMIR Diabetes in August 2023. Participants were current or former enrollees in an employer-sponsored health plan, were 18 years of age or older, had a T2D diagnosis, and were not using prandial insulin. Outcomes included CGM-based glycemic metrics and engagement with the BlueStar app, including logging of medications, exercise, food details, blood pressure, weight, and hours of sleep. Researchers found that the combination of the AI-powered digital health solution and RT-CGM helped people with T2D improve their glycemic outcomes and their diabetes self-management behaviors. (Kumbara, 2023)

Sources:

Whooley, S. (2023, Aug 23). Drug Delivery Business News. Welldoc gets FDA nod for CGM-guided insulin bolus dosing software. https://www.drugdeliverybusiness.com/welldoc-fda-cgm-guided-insulin-dosing-software/

(2023, Aug 23). BusinessWire. Welldoc receives 11th 510(k) clearance from FDA for award-winning diabetes platform BlueStar. https://www.businesswire.com/news/home/20230823298365/en/Welldoc-Receives-11th-510-k-Clearance-from-FDA-for-Award-Winning-Diabetes-Platform-BlueStar%C2%AE

Nuha A., et al, on behalf of the American Diabetes Association. (2023, Jan 1). Diabetes Care. Diabetes Technology: Standards of Care in Diabetes—2023.  https://diabetesjournals.org/care/article/46/Supplement_1/S111/148041/7-Diabetes-Technology-Standards-of-Care-in

Kumbara AB, et al. (2023, Aug 16). JMIR Diabetes. Impact of a Combined Continuous Glucose Monitoring - Digital Health Solution on Glucose Metrics and Self-Management Behavior for Adults with Type 2 Diabetes. https://pubmed.ncbi.nlm.nih.gov/37590491/