Eli Lilly will begin rollout of its first connected platform, the Tempo Personalized Diabetes Management Platform, later this year in the U.S. The technology aims to help adults living with type 1 or type 2 diabetes and clinicians make informed, data-backed decisions to manage treatment with Lilly insulins.
The platform consists of three key components – the Tempo Smart Button; a compatible app, TempoSmart; and a prefilled insulin pen, Tempo Pen – which work together to deliver personalized guidance for adults with diabetes. The Smart Button was cleared by the U.S. Food and Drug Administration on September 16. The compatible app was developed in partnership with Welldoc and is a private label iteration of the company's BlueStar, a diabetes management app, customized to receive insulin dose-related data from the Tempo Smart Button.
Healthcare providers will have access to a clinician hub, Tempo Insights, where they can access data shared by their patients through the app and track patients' progress.
"Lilly has over a century of knowledge of insulin and its complexities, and recognizes the emotional impact of managing diabetes," said Kevin Cammack, Head of Connected Care, Lilly Diabetes. "Launching this platform is an opportunity for us to more broadly support those who rely on our insulins."
Here's how the platform works: The Tempo Smart Button is a reusable medical device that attaches to the top of a Tempo Pen ― Lilly's prefilled, disposable insulin pens approved in 2019 and 2020. When paired via Bluetooth wireless technology, the Smart Button is intended to detect, store and transfer insulin dose-related data to the compatible app. The app, TempoSmart, will record insulin dose information and facilitate data sharing between adults with diabetes and the healthcare providers who treat them.
Adults with diabetes can access insulin dose information and advanced features through TempoSmart, including:
- Medication reminders, personalized education resources and feedback on blood glucose levels.
- Integration with Dexcom Continuous Glucose Monitoring (CGM) Systems via secondary display, as well as the Tempo Blood Glucose Monitor (BGM) and other compatible BGMs.
- Compatibility to sync data with wearable devices from Fitbit, Garmin, Google Fit and the Apple Health app.
"Despite technological advancements, people continue to experience challenges with the complexities of insulin dosing," said Cammack. "Using the learnings from early adopters of Tempo, we look forward to continually innovating our technology to aid those who use Lilly insulins to manage their diabetes."
Lilly will conduct a phased rollout for the platform to select clinics starting later this year, followed by national availability targeted for 2023. The Tempo Pen is currently available for Lyumjev (insulin lispro-aabc) injection, 100 units/mL, BASAGLAR (insulin glargine) injection, 100 units/mL, and Humalog (insulin lispro injection) 100 units/mL. Lilly continues to work with Welldoc to integrate additional features for TempoSmart in future software updates.
Outside of the U.S., Lilly received CE (Conformité Européenne or European Conformity) marking certification for the Tempo Smart Button on August 10 and plans to begin small-scale pilots in selected countries through partnerships with existing diabetes management ecosystems.