This is the 7th FDA 510(k) clearance for BlueStar, which was initially cleared for adults with type 2 diabetes
Columbia, MD – November 5, 2019 – Welldoc, a leading digital health company, announced today an additional FDA-clearance for its BlueStar® digital health product. The new enhancements include Continuous Glucose Monitoring (CGM) integration, as well as features to support individuals living with type 1 diabetes. This clearance demonstrates Welldoc’s commitment to providing BlueStar as a digital health product to support more people living with diabetes.
“With this clearance, we are very proud to bring BlueStar to support people living with type 1 diabetes,” said Welldoc Chief Medical Officer Mansur Shomali, MD, CM. “People with type 1 diabetes have unique challenges and needs. They have to manage glucose, food, insulin, and physical activity throughout their hectic daily schedules. They can now use BlueStar to simplify some of their diabetes-related tasks such as calculating carbs, dosing insulin, and connecting to their favorite devices.”
BlueStar’s insulin-dosing support has been further enhanced with the addition of an insulin on board (IOB) feature, which helps minimize the risk of hypoglycemia. In addition, BlueStar users will be able to view and learn from their Dexcom CGM data. Users will receive integrated insights regarding how their food choices, medications, and activity affect their glucose patterns. Healthcare providers will also be able to receive their patient’s CGM data, along with self-management data to make more effective adjustments to the treatment plan.
Type 1 diabetes affects approximately 1.25 million Americans and adds significant burden to patients, their families, and the healthcare system. This form of diabetes occurs when little and no insulin is produced by the pancreas, requiring constant attention to glucose, food, and insulin in order to stay well.
Welldoc®, a founding member of the Digital Therapeutics Alliance, is a pioneer in revolutionizing chronic disease management to help transform lives. BlueStar® was the first FDA-cleared digital health solution that guides individuals through the complicated journey of living with diabetes. By helping individuals with chronic disease self-manage their conditions and connecting them to their own healthcare team, Welldoc streamlines payers, employers and healthcare systems resources by focusing on a digital health solution to help better manage their populations living with multiple and costly chronic diseases. Having conducted several randomized clinical trials, demonstration projects, and real-world studies resulting in more than 40 peer-reviewed publications, Welldoc is based on a life science model. BlueStar has been recognized by IQVIA in 2017 as the “Top App” for type 2 diabetes treatment, awarded Diabetes Technology Society’s 2019 Digital Diabetes Congress Mobile App Contest in the “Established App” category, and MedTech Breakthrough’s 2019 “Best Personal Health App” award. Welldoc has created a suite of products that apply across a chronic disease domain. In 2019, Welldoc received its 10th patent with 9 others pending. For more information, visit www.welldoc.com.