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FDA Clears MiniMed™ 780G System to Enable Integration with the Instinct Sensor, Made by Abbott, and Approves Use in Type 2 Diabetes
Prnewswire· 2025-09-02 12:45
Core Viewpoint - Medtronic has achieved significant FDA regulatory milestones for its MiniMed™ 780G system, expanding its use to adults with insulin-requiring type 2 diabetes and enabling integration with Abbott's Instinct sensor for type 1 diabetes management [1][4]. Group 1: Regulatory Milestones - The FDA has cleared the SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC), allowing integration with Abbott's Instinct sensor for type 1 diabetes [1]. - The MiniMed™ 780G system is now approved for use in adults aged 18 and older with insulin-requiring type 2 diabetes, making it the first automated insulin delivery (AID) system with Meal Detection™ technology for this demographic [4][5]. Group 2: Product Features and Benefits - The Instinct sensor, designed by Abbott, is noted as the world's smallest, thinnest, and most discreet integrated continuous glucose monitor (iCGM), with a wear time of up to 15 days [2]. - Clinical trials have shown that the MiniMed™ 780G system can lead to a 0.7% reduction in HbA1c and an increase in Time in Range from 72% to 81% [6]. Group 3: Future Plans and Customer Access - Medtronic and Abbott are finalizing compliance documentation for sensor integration, with ordering for the Instinct sensor expected to begin shortly [3]. - Existing customers will have priority access through the Innovations Program, and pre-orders for the Simplera Sync™ sensor will start later this month [3].