Welldoc, Inc., and Eli Lilly and Company announced a collaboration and licensing agreement to integrate Welldoc’s software into Lilly’s connected insulin solutions, currently in development. Under the terms of the agreement, Lilly and Welldoc will collaborate to create a new version of the BlueStar insulin management solution that integrates insulin dosing data for several Lilly insulins. Lilly will commercialize the pen platform, which will include the new app and Lilly’s connected insulin pen solutions.
Welldoc’s BlueStar app is a digital health solution cleared by the U.S. Food and Drug Administration (FDA) for use by adults with type 1 or type 2 diabetes. The app has both prescription and non-prescription features such as insulin titration support, a bolus calculator and personalized health coaching, and integrates blood glucose monitoring and continuous glucose monitoring for people who use insulin.
The new app will integrate insulin dosing data for several Lilly insulins. In the first version of the 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 fully 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.
“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 Kevin McRaith, President and CEO of Welldoc. “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 in 2021 for the data transfer module, and Welldoc plans to submit to the FDA in 2021 for the new app. The prefilled, disposable insulin pen to be used in the first version of the pen platform was approved by the FDA in late 2019. If cleared, Lilly plans to commercialize the initial pen platform in the United States and will evaluate opportunities to launch the platform in other geographies. 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, vice president 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.”