FDA Approves Automated Insulin Delivery System for Adults With T2D: Daily Dose

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On September 3, 2025, we reported on the clearance of Medtronic’s MiniMed 780G automated insulin delivery (AID) system to be integrated with Abbott’s Instinct continuous glucose monitoring (CGM) sensor for individuals with type 1 diabetes (T1D) and FDA approval of the the system for use in adults with insulin-requiring type 2 diabetes (T2D).

The clearance

The FDA 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.

The approval

The FDA approval of MiniMed 780G for adults with insulin-requiring T2D made the device the first and only AID system with Meal Detection technology available for this population. 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.

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