FDA Approves MiniMed™ 780G for Type 2 Diabetes with Instinct Integration
Medtronic plc, a pioneer in healthcare technology based in Galway, Ireland, has recently achieved significant regulatory milestones in the treatment of diabetes. On September 2, 2025, the U.S. Food and Drug Administration (FDA) announced the clearance of Medtronic's MiniMed™ 780G system, allowing for integration with the Instinct sensor developed by Abbott. This advancement is particularly noteworthy as it expands the system's use to adults aged 18 and older who require insulin management due to Type 2 diabetes.
The MiniMed™ 780G system employs the SmartGuard™ algorithm, recognized for its innovative automated glycemic control capabilities. With the new integration, users can expect a more seamless and flexible experience in managing their diabetes. Que Dallara, Executive Vice President and Acting CEO of Medtronic Diabetes, emphasized the importance of this development, stating that it enhances the 'smart dosing ecosystem' for diabetes management. He expressed excitement about the prospect of making advanced diabetes technologies accessible to a broader audience.
The Instinct sensor, designed exclusively for compatibility with the MiniMed™ system, is claimed to be the world's smallest and most discreet integrated continuous glucose monitor (iCGM). This device offers a remarkable wear time of up to 15 days, making it a convenient option for users. With the FDA's clearance, Medtronic can now expedite the sensor integration process. Pre-orders for both the Instinct sensor and the associated Simplera Sync™ sensor are anticipated to start later this month, offering existing customers the chance for early access through the Innovations Program.
In a separate yet related advancement, the FDA has also officially approved the MiniMed™ 780G system for individuals diagnosed with insulin-requiring type 2 diabetes. This makes the MiniMed™ 780G the first automated insulin delivery (AID) system equipped with Meal Detection™ technology specifically accessible to this demographic. The approval aligns with the American Diabetes Association's (ADA) latest Standards of Care, which now comprehensively endorse AID systems for adults on intensive insulin therapy. This development means that many individuals living with Type 2 diabetes, who face constant challenges alongside their physical and emotional health, can better simplify their treatment regimen.
Clinical studies highlight the MiniMed™ 780G's efficacy. In a pivotal trial involving the system's use alongside Abbott's Guardian™ 4 sensor and Simplera Sync™ sensor, participants recorded a statistically significant reduction of 0.7% in HbA1c levels from a pre-trial average of 7.9%. Additionally, the study observed an increase in Time in Range, with participants maintaining optimal glucose levels for 81% of the time, compared to 72% at the study's onset. A complementary single-arm study reported even better outcomes: A1C levels decreased from 7.7% to 6.9%, and Time in Range rose from 76.4% to 84.9%. These results underscore not just the system's clinical effectiveness but also its positive impact on the quality of life and reduced diabetes distress among users.
Medtronic continues to push boundaries in diabetes management, with a commitment to designing a future characterized by cutting-edge sensors and intelligent dosing practices. They also aim to submit 510(k) applications for further clearances that will foster even greater integration of their pumping systems with Abbott's sensors.
Founded over 40 years ago, Medtronic has positioned itself as a leader in healthcare technology, dedicated to elevating diabetes management to new heights. With Medtronic Cannabis Solutions bringing forth innovative technologies, the launch of the MiniMed™ 780G system is a significant leap towards providing people living with diabetes the personalized support they need.
With these advancements, Medtronic sets a new standard in diabetes care, making it possible for individuals to embrace a fuller life with better disease management.
The MiniMed™ 780G system employs the SmartGuard™ algorithm, recognized for its innovative automated glycemic control capabilities. With the new integration, users can expect a more seamless and flexible experience in managing their diabetes. Que Dallara, Executive Vice President and Acting CEO of Medtronic Diabetes, emphasized the importance of this development, stating that it enhances the 'smart dosing ecosystem' for diabetes management. He expressed excitement about the prospect of making advanced diabetes technologies accessible to a broader audience.
The Instinct sensor, designed exclusively for compatibility with the MiniMed™ system, is claimed to be the world's smallest and most discreet integrated continuous glucose monitor (iCGM). This device offers a remarkable wear time of up to 15 days, making it a convenient option for users. With the FDA's clearance, Medtronic can now expedite the sensor integration process. Pre-orders for both the Instinct sensor and the associated Simplera Sync™ sensor are anticipated to start later this month, offering existing customers the chance for early access through the Innovations Program.
In a separate yet related advancement, the FDA has also officially approved the MiniMed™ 780G system for individuals diagnosed with insulin-requiring type 2 diabetes. This makes the MiniMed™ 780G the first automated insulin delivery (AID) system equipped with Meal Detection™ technology specifically accessible to this demographic. The approval aligns with the American Diabetes Association's (ADA) latest Standards of Care, which now comprehensively endorse AID systems for adults on intensive insulin therapy. This development means that many individuals living with Type 2 diabetes, who face constant challenges alongside their physical and emotional health, can better simplify their treatment regimen.
Clinical studies highlight the MiniMed™ 780G's efficacy. In a pivotal trial involving the system's use alongside Abbott's Guardian™ 4 sensor and Simplera Sync™ sensor, participants recorded a statistically significant reduction of 0.7% in HbA1c levels from a pre-trial average of 7.9%. Additionally, the study observed an increase in Time in Range, with participants maintaining optimal glucose levels for 81% of the time, compared to 72% at the study's onset. A complementary single-arm study reported even better outcomes: A1C levels decreased from 7.7% to 6.9%, and Time in Range rose from 76.4% to 84.9%. These results underscore not just the system's clinical effectiveness but also its positive impact on the quality of life and reduced diabetes distress among users.
Medtronic continues to push boundaries in diabetes management, with a commitment to designing a future characterized by cutting-edge sensors and intelligent dosing practices. They also aim to submit 510(k) applications for further clearances that will foster even greater integration of their pumping systems with Abbott's sensors.
Founded over 40 years ago, Medtronic has positioned itself as a leader in healthcare technology, dedicated to elevating diabetes management to new heights. With Medtronic Cannabis Solutions bringing forth innovative technologies, the launch of the MiniMed™ 780G system is a significant leap towards providing people living with diabetes the personalized support they need.
With these advancements, Medtronic sets a new standard in diabetes care, making it possible for individuals to embrace a fuller life with better disease management.
Topics Health）
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