Dive Brief:
- Medtronic said Monday it received 510(k) clearance from the Food and Drug Administration for an app to connect its smart insulin pens with a glucose sensor made by Abbott.
- The app, called MiniMed Go, provides alerts for missed insulin doses, a dose calculator and guidance on what to do if a person misses a dose. It also includes software reporting for providers.
- The pairing is part of a partnership Medtronic struck in 2024 for Abbott to make an integrated continuous glucose monitor sold exclusively by Medtronic.
Dive Insight:
Medtronic plans to launch the MiniMed Go app this spring. The company said the feature helps people using insulin pens with glycemic control.
A retrospective analysis found the average time in range, a measurement for the percentage of time a person's blood glucose stays within a target range, was 55.7%. Users responded to just under half of alerts for missed doses or high glucose with a bolus insulin dose, but the analysis found people who acted on the alerts within an hour had a better time in range.
Medtronic Diabetes President Que Dallara said the app is intended to provide access to automated insulin delivery systems for people who prefer insulin pens instead of insulin pumps. Medtronic sells reusable, smart insulin pens that connect with mobile apps to help with dose calculations and tracking, while Abbott’s partnered sensor has a 15-day wear time, longer than Medtronic’s other sensors currently on the market.
In December, Medtronic launched an automated insulin delivery system pairing the Abbott CGM with its latest insulin pump.
Medtronic partnered with Abbott as it navigates growing competition in the market for diabetes devices. Last year, Medtronic announced plans to spin out the segment into a standalone company called MiniMed, with Dallara as CEO.
