Lilly and Welldoc will create a new version of Welldoc’s BlueStar insulin management software, which will integrate insulin dosing data for several Lilly insulins.
The BlueStar app has FDA 510(k) clearance for use by adults with type 1 or type 2 diabetes. The app has both prescription and non-prescription features, including insulin titration support, a bolus calculator and personalized health coaching, and integrates blood glucose monitoring and continuous glucose monitoring for people who use insulin.
In the first version of the Lilly pen platform, a data-transfer module will attach to the top of a prefilled, disposable insulin pen. When paired with the compatible app, the module will automatically transfer insulin dosing data. Lilly is also developing a disposable connected insulin pen to be used in future versions of the platform. The app will aggregate various dimensions of personalized data and connect with healthcare providers to deliver actionable insights and provide new opportunities to optimize diabetes care, according to the companies.
“Insulin dosing data are a critical piece of the diabetes management puzzle for people who use insulin to manage their diabetes, and Lilly has made significant progress in developing connected insulin pen solutions to provide access to those data,” said Welldoc president & CEO Kevin McRaith in a news release. “Our software will now bring all of the most important diabetes data directly into the hands of people living with the condition, their caregivers and their healthcare providers. Bringing various elements of a patient’s care under one platform is critical for those who are managing multiple comorbidities and providers who are working to effectively manage population health. Welldoc’s platform combines a holistic approach with an evidence-based care model tailored to specific chronic conditions including diabetes, hypertension, behavioral health and more.”
Lilly plans to submit to the FDA this year for the data-transfer module, and Welldoc plans to submit to the FDA this year for the new app. The agency approved the prefilled, disposable insulin pen to be used in the first version of the pen platform in late 2019. If cleared, Lilly plans to commercialize the initial pen platform in the U.S. and will evaluate launch opportunities abroad. Welldoc will continue to separately commercialize the BlueStar app.
“Today, less than half of people who use insulins are achieving their target A1C goals. We want to simplify the experience of using insulin by integrating our medicines with the most innovative technology available,” said Marie Schiller, VP of product development for connected care and insulins at Lilly. “We are excited to collaborate with Welldoc. Together, we will combine their advanced software capabilities and expansive insulin management features with our connected insulin pen solutions with the goal of easing the burden of diabetes care on people living with the condition.”