Medtronic, a global leader in medical technology, has announced that its MiniMed 780G system with the Guardian 4 sensor has received approval from the U.S. Food and Drug Administration (FDA). This milestone marks the approval of the only system with meal detection technology that provides automatic adjustments and corrections to sugar levels every 5 minutes. The system is designed to address one of the biggest challenges faced by people living with type 1 diabetes – mealtimes.
The MiniMed 780G system features the lowest glucose target setting in any automated insulin pump on the market, as low as 100 mg/dL, which more closely mirrors the average glucose of someone not living with diabetes. With this setting, the pump will “treat to target” and will automatically deliver basal insulin adjustments and autocorrections to a set target. The system is also the only pump with an infusion set that can be worn for up to 7 days, doubling wear time with advanced materials that help reduce insulin preservative loss, maintain insulin flow and stability, resulting in a reduced risk of infusion set occlusion.
The new Guardian 4 sensor requires no fingersticks with SmartGuard technology, making the MiniMed 780G system more user-friendly. 94% of users have reported being satisfied with the impact the system has on their quality of life, and users also reported remaining in SmartGuard technology 95% of the time.
In the pivotal trial of the MiniMed 780G system, users experienced 75% Time in Range (blood sugar between 70-180 mg/dL), with overall Time Below Range of 1.8%. The system provided even greater protection at night with an overnight Time in Range of 82%, and overnight Time Below Range of 1.5%. With the use of the lower target of 100 mg/dL and active insulin time (AIT) set to two hours, Time in Range reached 78.8% without increasing hypoglycemia.
The system is approved for users seven years old and above with type 1 diabetes. Medtronic will begin taking pre-orders on May 15, 2023, with first shipments planned for later this summer. Customers on the company’s MiniMed 770G system today will be eligible to upgrade their device to the MiniMed 780G through a no-cost, remote software upgrade.
The MiniMed 780G system is a significant advancement in insulin pump technology, providing automatic, real-time insulin corrections and meal detection technology that help account for when users occasionally forget to bolus or underestimate the number of carbs in their meal. This system is designed to provide ease of use and greater protection for people living with type 1 diabetes.