Following the FDA clearance of its Tempo Smart Button in September, Eli Lilly and Company is debuting a connected platform to aid in the self-management of type 1 and type 2 diabetes. The platform includes the said Bluetooth-connected device that detects, stores, and transfers data related to insulin doses from a Tempo Pen. This FDA-cleared device from Lilly is a prefilled disposable pen that’s compatible with several insulins from the pharmaceutical company. Lilly’s Tempo Smart app tracks insulin doses, glucose levels, and the user’s lifestyle data. Together, these components form the three pillars of the new Tempo Personalized Diabetes Management Platform, which will roll out in select clinics later this year with plans to go national in 2023.

The new platform meets a rising need in America; according to the most recent data from the Centers for Disease Control and Prevention (CDC), diabetes prevalence significantly increased among U.S. adults from 2001 to 2020. The CDC estimates that 11.3% of the U.S. population — 37.3 million people — have diabetes, and that the cumulative cost in care and lost productivity tops $325 billion each year. The disease disproportionately affects people according to race, education, and income level; adults with a family income that’s below the federal poverty line have the country’s highest prevalence of diabetes. This makes cost-effective self-managed care all the more important.

So how does Lilly’s platform work? The reusable Tempo Smart Button attaches to the top of a disposable Tempo Pen, which is a popular alternative to needles that come pre-filled with insulin cartridges. Via a Bluetooth connection, the Smart Button sends data to the TempoSmart app, which records the insulin dose information and collates the data for sharing with healthcare providers. The app also features medication reminders, insights on blood glucose levels, and, perhaps best of all, integrates with other wearables. TempoSmart is compatible with Dexcom Continuous Glucose Monitoring (CGM) Systems, and syncs data with Fitbit and Garmin devices, as well as with the Google Fit and Apple Health apps.

Eli Lilly’s Kevin Cammack says of the planned rollout, “Launching this platform is an opportunity for us to more broadly support those who rely on our insulins…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.” And that broad support is looking beyond U.S. shores; in August, Lilly got a European Conformity (CE) certificate for the Tempo Smart Button, which clears the device for sale in the member states of the European Union. Small-scale pilot programs in select European countries are in the works.