Medtronic plc announced that the U.S. Food and Drug Administration (FDA) has cleared its SmartGuard algorithm as an interoperable automated glycemic controller, which will allow integration with Abbott’s Instinct sensor for people with type 1 diabetes. The FDA also approved the MiniMed 780G system for use in adults aged 18 and older with insulin-requiring type 2 diabetes.
“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. 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,” said Que Dallara, Executive Vice President and President of Medtronic Diabetes and CEO Designate of MiniMed. “We’re excited to expand our ecosystem of solutions under one roof with service our customers can count on around the clock.”
The clearance finalizes Medtronic’s FDA pre-market approval pathway for integrating the Instinct sensor into its MiniMed 780G system for those living with type 1 diabetes. The Instinct sensor is designed by Abbott specifically for use with MiniMed systems, offering up to a 15-day wear time and being among the smallest and thinnest integrated continuous glucose monitors available.
In upcoming weeks, Medtronic and Abbott plan to complete compliance documentation needed for marketing the integrated solution. Once this process is finished, ordering for the Instinct sensor used alongside the MiniMed 780G system will begin, prioritizing existing customers through Medtronic’s Innovations Program. Pre-orders for another sensor, Simplera Sync, are expected later this month.
“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.”
The FDA’s approval now allows adults who require insulin due to type 2 diabetes access to an automated insulin delivery (AID) system that features Meal Detection technology. This makes it currently the only AID system available to this population that includes such technology.
“This approval extends the benefits of automated insulin delivery to people with type 2 diabetes,” said Natalie Bellini, DNP, FNP, BC-ADM, CDCES, Endocrine Nurse Practitioner and Program Director for Diabetes Technology at University Hospitals in Cleveland, Ohio. “It also aligns with the ADA Standards of Care, which now formally endorse AID systems for individuals with type 2 diabetes on intensive insulin therapy.”
Adults managing type 2 diabetes who require insulin often deal with multiple daily injections as well as ongoing meal planning and glucose monitoring tasks. Recent clinical studies have shown that using Medtronic’s MiniMed 780G system can help improve blood sugar control while reducing treatment demands.
A pivotal trial found participants using Guardian 4 or Simplera Sync sensors experienced a reduction in HbA1c from a baseline of about 7.9% by approximately 0.7%, alongside increased time spent within target glucose range from roughly 72% up to about 81%. Another study reported similar improvements over three months: average A1C dropped from around 7.7% down to nearly 6.9%, while time in range rose from about 76% up toward almost 85%. Participants also noted better quality of life and less distress related to their condition.
Currently available for those managing type 2 diabetes when paired with Guardian 4 sensors—and soon available via pre-ordering when used alongside Simplera Sync—Medtronic intends further regulatory submissions seeking clearance for an interoperable pump indicated specifically for type 2 diabetes patients.
For additional information about Medtronic plc or its technologies across various health conditions including cardiac devices and surgical robotics—which are used globally—visit www.Medtronic.com or follow Medtronic on LinkedIn.
