Medtronic plc, a leading company in healthcare technology, has received two major approvals from the FDA that expand the features of its MiniMed 780G insulin delivery system. The first approval allows the use of its SmartGuard automated glycemic controller (iAGC), which now connects with Abbott’s Instinct sensor for people with type 1 diabetes. The second approval lets the MiniMed 780G system be used by adults aged 18 and older who have type 2 diabetes and need insulin. These approvals mark a significant step in broadening access to advanced diabetes technology for a wider group of patients.
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Que Dallara, Executive Vice President and President of Medtronic Diabetes, as well as the CEO-designate of MiniMed, emphasized the importance of these advancements. He explained that integrating the Instinct sensor with the MiniMed system offers more flexibility and choice to users, while also enhancing the overall experience with a smarter, more reliable insulin delivery system. This move is aimed at making diabetes care easier and more effective for those who rely on it daily.
The FDA clearance also finalizes the necessary approval process for integrating the Instinct sensor with the MiniMed 780G system for people living with type 1 diabetes. Known for its small and discreet design, the Instinct sensor can be worn for up to 15 days and is considered one of the most convenient continuous glucose monitors available. Medtronic and Abbott are now completing the final regulatory steps to make the sensor commercially available, starting with existing MiniMed customers through their Innovations Program.
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Chris Scoggins, Executive Vice President of Abbott’s diabetes care division, shared that their collaboration with Medtronic aims to simplify diabetes management. By combining Abbott’s proven CGM technology with Medtronic’s smart insulin pump, the goal is to ease the daily responsibilities of people living with diabetes. He said this integration offers a smoother experience by reducing the mental load that comes with managing glucose levels and insulin delivery.
The FDA has also approved the MiniMed 780G system for use in adults with type 2 diabetes who require insulin, making it the first automated insulin delivery system with Meal Detection technology available to this group. Natalie Bellini, a diabetes nurse practitioner and Program Director at University Hospitals in Cleveland, said this is in line with the latest guidelines from the American Diabetes Association, which now support AID systems for type 2 patients on intensive insulin therapy. Clinical data shows meaningful results: one study revealed a 0.7% drop in HbA1c and an increase in time-in-range to 81%, while another showed a reduction in A1c from 7.7% to 6.9% and a rise in time-in-range to nearly 85% over just three months. Medtronic is preparing to launch pre-orders for the system with its new Simplera Sync sensor and plans to file additional applications to make the Instinct sensor available for type 2 users in the future.
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