Medtronic plc announced two significant FDA regulatory milestones that expand access to its MiniMed 780G automated insulin delivery system. The FDA cleared the company's SmartGuard algorithm as an interoperable automated glycemic controller (iAGC), enabling integration with Abbott's Instinct sensor for type 1 diabetes, and approved the MiniMed 780G system for use in adults 18 and older with insulin-requiring type 2 diabetes.
Breakthrough Integration with Abbott's Instinct Sensor
The FDA clearance, combined with the previously cleared MiniMed 780G insulin pump as an alternate controller enabled (ACE) pump, completes Medtronic's FDA pre-market approval pathway for Instinct sensor integration with the MiniMed 780G system for people living with type 1 diabetes. The Instinct sensor, designed exclusively by Abbott for MiniMed automated insulin delivery and Smart MDI systems, represents the world's smallest, thinnest, most discreet integrated CGM (iCGM) and offers a wear time of up to 15 days.
"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."
In the coming weeks, Medtronic and Abbott plan to complete their required compliance documentation enabling sensor integration and marketing. Completion of this step will promptly finalize the regulatory process, after which ordering for the Instinct sensor with the MiniMed 780G system will begin. Existing customers will have priority access through the Innovations Program, with pre-orders for Simplera Sync sensor also beginning later this month.
First AID System for Type 2 Diabetes with Meal Detection
The FDA approval for type 2 diabetes makes the MiniMed 780G system the first and only automated insulin delivery (AID) system with Meal Detection technology available to this population. This approval aligns with the American Diabetes Association Standards of Care, which now formally endorse AID systems for individuals with type 2 diabetes on intensive insulin therapy.
"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."
Clinical Evidence Demonstrates Significant Improvements
Clinical evidence from recent studies demonstrates substantial improvements in glycemic outcomes for type 2 diabetes patients using the MiniMed 780G system. In a recently published pivotal trial with 95 participants using the Guardian 4 sensor and Simplera Sync sensor, participants experienced a 0.7% reduction in HbA1c from a baseline of 7.9% and an increase in Time in Range to 81% from a baseline of 72%, with minimal hypoglycemia.
A separate single-arm study involving 236 participants showed even more dramatic results, with A1C decreasing from 7.7% to 6.9%, and Time in Range increasing from 76.4% to 84.9% during 90 days of advanced hybrid closed-loop use with low time-below-range (70 mg/dL) of 0.3%. Participants also reported improvements in quality of life and reductions in diabetes distress.
Expanding Treatment Options
People living with type 2 diabetes who require insulin face daily challenges that affect both their physical health and emotional well-being, including frequent injections, meal planning, and glucose monitoring. The MiniMed 780G system addresses these challenges by reducing treatment burden while improving glycemic outcomes.
"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 MiniMed 780G system is currently available for type 2 diabetes with the Guardian 4 sensor and will be available with Simplera Sync sensor when pre-orders begin later this month. Medtronic also plans to submit 510(k) applications seeking clearance for an interoperable pump indicated for type 2 diabetes, which would enable future integration with the Instinct sensor.
