The automated insulin delivery system is now approved for adults with type 2 diabetes and cleared for interoperability with Abbott’s Instinct sensor for type 1 diabetes.
Medtronic announced two US Food and Drug Administration (FDA) regulatory authorizations that broaden the MiniMed 780G system portfolio: clearance of the SmartGuard algorithm as an interoperable automated glycemic controller (iAGC), enabling integration with the Instinct sensor, made by Abbott, for type 1 diabetes, and approval of the MiniMed 780G system for use in adults 18 and older with insulin-requiring type 2 diabetes.
The clearance of the SmartGuard algorithm as an iAGC completes the regulatory pathway for integrating the Abbott-made Instinct sensor with the MiniMed 780G system. The Instinct sensor, designed by Abbott for Medtronic’s automated insulin delivery systems, features a wear time of up to 15 days. This interoperability aims to provide more flexibility for patients and clinicians in managing diabetes technology.
“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,” says Que Dallara, executive vice president and president of Medtronic diabetes and CEO Designate of MiniMed, in a release.
Medtronic and Abbott plan to complete the necessary compliance documentation in the coming weeks to enable sensor integration and marketing. Once finalized, ordering for the Instinct sensor with the MiniMed 780G system will begin.
“Abbott’s biowearable technology has long set the standard for accurate, accessible, easy-to-use continuous glucose monitoring,” says Chris Scoggins, executive vice president of Abbott’s diabetes care business, in a release. “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.”
New Indication for Type 2 Diabetes
The FDA’s approval for the MiniMed 780G system in adults with insulin-requiring type 2 diabetes aligns with recent American Diabetes Association Standards of Care, which now endorse automated insulin delivery systems for individuals with type 2 diabetes who are on intensive insulin therapy.
“This approval extends the benefits of automated insulin delivery to people with type 2 diabetes,” says Natalie Bellini, DNP, FNP, BC-ADM, CDCES, endocrine nurse practitioner and program director for diabetes technology at University Hospitals in Cleveland, Ohio, in a release.
For the type 2 diabetes indication, the MiniMed 780G system is currently available with the Guardian 4 sensor. It will also be compatible with the Simplera Sync sensor when pre-orders open later this month. Medtronic also intends to submit 510(k) applications for an interoperable pump for type 2 diabetes, which would allow for future integration with the Instinct sensor for this population as well.
Photo caption: MiniMed and Instinct sensor
Photo credit: Medtronic
