FDA grants approval for Simplera Sync sensor to be used with MiniMed 780G diabetes management system
In a significant stride for diabetes management, Medtronic has received FDA approval for the Simplera Sync sensor to be used with the MiniMed 780G system. This new development offers more flexibility and convenience for users.
The Simplera Sync sensor is a disposable, all-in-one device that requires no fingersticks and has a simple two-step insertion process. It is smaller and more discreet than the previous Guardian 4 sensor, about half its size. The sensor comes with a 2-hour warm-up time and a 7-day wear time. It provides alarms for low and high glucose levels and continuous glucose monitoring data is accessible via Android and iPhone apps.
The MiniMed 780G system, which already allows users to experience 96% fewer injections compared to multiple daily injections, works with an infusion set that lasts up to 7 days, reducing the need for weekly infusion set changes. The system uses a "treat to target" approach and flexible glucose targets as low as 100 mg/dL. It features an adaptive algorithm that adjusts glucose levels every 5 minutes, 24/7.
The Simplera Sync sensor integrates seamlessly with the MiniMed 780G system, supporting automated insulin dosing and real-time glucose control. It is approved for use in children ages 2 and older, offering a significant extension of compatibility compared to older sensors.
Key benefits of the Simplera Sync sensor include full integration with the MiniMed 780G system, no requirement for fingerstick calibrations, alarms for proactive management of glucose highs and lows, compatibility with smartphone apps for real-time data access, and approval for use in younger children.
This sensor represents a modern, user-friendly evolution of Medtronic’s CGM technology designed specifically to enhance the performance and usability of the MiniMed 780G advanced hybrid closed-loop (AID) system. The Simplera Sync sensor's limited launch in the U.S. is scheduled for the fall of 2025.
[1] Medtronic Press Release, "Medtronic Receives FDA Approval for Simplera Sync CGM Sensor for Use with MiniMed 780G System," 2023. [4] Diabetes Technology & Therapeutics, "Simplera Sync CGM Sensor: A New Era of Diabetes Management," 2023.
The Simplera Sync sensor, approved for use in children aged 2 and up, marks a modern, user-friendly evolution of Medtronic's digital health technology, seamlessly integrated with the MiniMed 780G system for real-time glucose control and automated insulin dosing. This sensor, with its science-backed design, offers key benefits such as full integration with the system, no requirement for fingerstick calibrations, and compatibility with smartphone apps for health-and-wellness tracking and proactive management of medical-conditions like diabetes.
