Key Highlights
- FDA clears SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC) with Abbott’s Instinct sensor for type 1 diabetes
- FDA approves MiniMed™ 780G system for insulin-requiring type 2 diabetes, expanding access to advanced automated insulin delivery
- First and only AID system with Meal Detection™ technology for type 2 diabetes, signaling a major step forward in patient care
Expanding Integration Through Abbott Partnership
The U.S. FDA has cleared Medtronic’s SmartGuard™ algorithm as an interoperable automated glycemic controller, enabling integration of the MiniMed™ 780G system with Abbott’s Instinct sensor for type 1 diabetes. The Instinct sensor is the world’s smallest and most discreet integrated CGM, with up to 15 days wear time, designed exclusively for MiniMed™ automated insulin delivery. This clearance marks a key milestone in the collaboration between Medtronic and Abbott, giving patients greater choice, flexibility, and convenience.
Broadening Indications to Type 2 Diabetes
In a parallel decision, the FDA also approved the MiniMed™ 780G system for adults with insulin-requiring type 2 diabetes — making it the first automated insulin delivery (AID) system with Meal Detection™ technology available to this population. This regulatory expansion significantly broadens the system’s reach, offering smart insulin dosing solutions to millions of patients who struggle with intensive daily management.
Clinical Data Shows Strong Outcomes
Clinical evidence underscores the impact of the MiniMed™ 780G system in type 2 diabetes care. In a pivotal trial of 95 participants, HbA1c dropped by 0.7% and Time in Range rose to 81%, with minimal hypoglycemia. In a separate study of 236 participants, HbA1c decreased from 7.7% to 6.9% while Time in Range improved to 84.9% over 90 days. Patients also reported better quality of life and lower diabetes-related distress, pointing to both clinical and emotional benefits.
Redefining the Diabetes Technology Landscape
These dual regulatory milestones position Medtronic and Abbott to lead the next phase of connected diabetes care. By combining interoperable pumps, next-generation CGMs, AI-powered algorithms, and Meal Detection™ technology, the partners aim to build a comprehensive, patient-first diabetes management ecosystem. With global diabetes prevalence rising, this integrated platform could redefine standards of care for type 1 and type 2 populations alike.
About Medtronic
Medtronic, headquartered in Galway, Ireland, is a global healthcare technology leader with 95,000+ employees across 150 countries. Its mission is to alleviate pain, restore health, and extend life through innovations spanning surgical robotics, cardiac devices, insulin pumps, and patient monitoring solutions. Medtronic’s technologies treat more than 70 conditions and improve the lives of two people every second worldwide.
About Abbott
Abbott is a global healthcare company that develops life-changing technologies across diagnostics, medical devices, nutritionals, and branded generics. Abbott’s diabetes care business has pioneered leading continuous glucose monitoring (CGM) systems, advancing biowearable innovation to help millions of people live healthier lives with reduced burden of daily disease management.
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