FDA Approves Automated Insulin Delivery System for Adults With Type 2 Diabetes

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The US FDA has cleared Medtronic’s MiniMed 780G automated insulin delivery (AID) system to integrate with Abbott’s Instinct continuous glucose monitoring (CGM) sensor for individuals with type 1 diabetes (T1D) and approved the system for use in adults with insulin-requiring type 2 diabetes (T2D), the company announced September 2, 2025.¹

The clearance enables Medtronic’s SmartGuard algorithm to function as an interoperable automated glycemic controller with the Instinct sensor. The device, described as the smallest and thinnest integrated CGM available, offers up to 15 days of wear. Medtronic and Abbott plan to complete compliance documentation in the coming weeks, after which ordering for the Instinct sensor with MiniMed 780G will begin, with priority access for existing customers.¹

Separately, the FDA approved MiniMed 780G for adults with insulin-requiring T2D, making it the first and only AID system with Meal Detection technology available for this population.¹ Clinical evidence published earlier this year from the IMPACT2D clinical trial demonstrated improved outcomes, including HbA_1c reductions of 0.7% from a baseline of 7.9% and an increase in time-in-range to 81% in one pivotal trial. In another single-arm study, HbA_1C decreased from 7.7% to 6.9% and time-in-range increased from 76.4% to 84.9% over 90 days, with minimal hypoglycemia.²

"This approval extends the benefits of automated insulin delivery to people with type 2 diabetes," Natalie Bellini, DNP, Endocrine Nurse Practitioner and Program Director for Diabetes Technology at University Hospitals in Cleveland, Ohio, said in a press release. "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."¹

The MiniMed 780G system is already available for T2D when used with Medtronic’s Guardian 4 sensor and will also be compatible with the Simplera Sync sensor later this year. The company reported plans to seek additional FDA clearance for an interoperable pump for T2D to enable future integration with the Instinct sensor.¹

Medtronic stated that these milestones reflect an expansion of its automated insulin delivery ecosystem, aiming to provide more choice, flexibility, and integration for people with type 1 diabetes and T2D.¹

"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," Que Dallara, Executive Vice President and President of Medtronic Diabetes and CEO Designate of MiniMed, said in the press release. "We're excited to expand our ecosystem of solutions under one roof with service our customers can count on around the clock."¹

References:

1. Medtronic. FDA clears MiniMed 780G system to enable integration with the Instinct sensor, made by Abbott, and approves use in type 2 diabetes. News release. September 2, 2025. Accessed September 3, 2025. https://news.medtronic.com/2025-09-02-FDA-Clears-MiniMed-TM-780G-System-to-Enable-Integration-with-the-Instinct-Sensor,-Made-by-Abbott,-and-Approves-Use-in-Type-2-Diabetes
2. Bhargava A, Bergenstal RM, Warren ML, et al. Safety and Effectiveness of MiniMedTM 780G Advanced Hybrid Closed-Loop Insulin Intensification in Adults with Insulin-Requiring Type 2 Diabetes. Diabetes Technol Ther. 2025;27:366-375. doi:10.1089/dia.2024.0586