Medtronic has revealed two U.S. Food and Drug Administration (FDA) regulatory milestones that expand its MiniMed 780G system portfolio.

First is clearance of the SmartGuard algorithm as an interoperable automated glycemic controller (iAGC), enabling integration with the Instinct sensor made by Abbott in partnership with Medtronic, for type 1 diabetes. The second is approval of MiniMed 780G for adults with insulin-requiring type 2 diabetes.

The clearance, along with MiniMed 780G’s previous clearance as an alternate controller enabled (ACE) pump, completes Medtronic’s FDA premarket approval for the Instinct sensor integration with MiniMed 780G for people with type 1 diabetes. Abbott exclusively designed the Instinct sensor for MiniMed automated insulin delivery (AID) and Smart MDI systems. The duo said it’s the world’s smallest, thinnest, and most discreet integrated CGM (iCGM) and has a wear time of up to 15 days.

Medtronic and Abbott said they plan to complete required compliance documentation in the coming weeks to enable sensor integration and marketing. Completing the step finalizes the regulatory process, after which ordering for Instinct with MiniMed 780G will start.

“These milestones mark an important next step in our work to bring the proven performance and outcomes of our MiniMed 780G automated insulin delivery system to more people living with diabetes,” said Que Dallara, Executive Vice President and President of Medtronic Diabetes and CEO Designate of MiniMed. “By enabling integration with the Instinct sensor and expanding the MiniMed 780G system to people with type 2 diabetes, we are advancing a smart dosing ecosystem designed to provide greater choice and flexibility, along with a more seamless experience. We’re excited to expand our ecosystem of solutions under one roof with service our customers can count on around the clock.”

Indication for type 2 diabetes

MiniMed 780G’s approval for insulin-requiring type 2 diabetes makes it the first and only AID system with Meal Detection technology available to this population.

Clinical evidence showed using MiniMed 780G can improve glycemic outcomes and reduce treatment burden. In a recent pivotal trial with the Guardian 4 and Simplera Sync sensors, participants had a 0.7% reduction in HbA1c and increase in Time in Range to 81%, with minimal hypoglycemia. A separate single-arm study showed A1C decreased from 7.7% to 6.9% and Time in Range increased from 76.4% to 84.9% during 90 days of advanced hybrid closed-loop use.

MiniMed 780G is currently available for type 2 diabetes with the Guardian 4 sensor and will be available with the Simplera Sync sensor later this month. Medtronic said it plans to submit 510(k) applications for an interoperable pump indicated for type 2 diabetes, enabling future integration with the Instinct sensor.

“We’re working together to do what’s best for people living with diabetes,” said Chris Scoggins, Executive Vice President of Abbott’s diabetes care business. “Abbott’s biowearable technology has long set the standard for accurate, accessible, easy-to-use continuous glucose monitoring. Connecting it with the MiniMed 780G system aims to reduce the mental load of daily management, making it easier for people to live with diabetes.”