What's Happening?
Medtronic plc has announced FDA approval for the MiniMed 780G system to be used in adults with insulin-requiring type 2 diabetes. The system, which includes the SmartGuard algorithm, is now cleared to integrate with Abbott's Instinct sensor, enhancing its capabilities for type 1 diabetes management. The MiniMed 780G system is the first automated insulin delivery system with Meal Detection technology available for type 2 diabetes. This approval aligns with the American Diabetes Association's standards of care, endorsing automated insulin delivery systems for individuals with type 2 diabetes on intensive insulin therapy.
Why It's Important?
The FDA's approval of the MiniMed 780G system for type 2 diabetes marks a significant advancement in diabetes management technology. By integrating with Abbott's Instinct sensor, the system offers improved glycemic outcomes and reduces the treatment burden for individuals with diabetes. This development provides greater choice and flexibility for patients, potentially improving their quality of life and reducing diabetes-related distress. The approval also reflects the growing acceptance of automated insulin delivery systems in clinical practice, which could lead to broader adoption and innovation in diabetes care.
What's Next?
Medtronic and Abbott plan to complete compliance documentation for sensor integration and marketing, with ordering for the Instinct sensor expected to begin soon. Medtronic also intends to submit 510(k) applications for an interoperable pump indicated for type 2 diabetes, enabling future integration with the Instinct sensor. These steps will expand the availability of the MiniMed 780G system and its associated technologies, offering more options for diabetes management. The continued development and approval of advanced diabetes technologies may drive further improvements in patient outcomes and healthcare practices.