The FDA recently approved the MiniMed 780G system with the Guardian 4 sensor requiring no fingersticks while in SmartGuard technology, according to an announcement from the device’s manufacturer.

According to a press release, 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 provides insulin to help account for when users occasionally forget to bolus or underestimates the number of carbs in their meal. "Mealtimes prove to be one of the biggest challenges for people living with type 1 diabetes and now for the first time, the MiniMed 780G system addresses this unmet need with automatic, real-time insulin corrections," Que Dallara, EVP and president of Medtronic Diabetes, wrote in the release.

The MiniMed 780G system features a glucose target setting as low as 100 mg/dl one that 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.

According to the release, the MiniMed is the only pump with an infusion set that can be worn for up to 7 days, potentially doubling wear time with advanced materials that help reduce insulin preservative loss and maintain insulin flow and stability, which reduces the risk of infusion set occlusion.

Patients included in the US pivotal trial of the MiniMed 780G system experienced 75% Time in Range (blood sugar between 70-180 mg/dl) with an overall Time Below Range of 1.8%5. The researchers found that 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 use of the lower target of 100 mg/dl and active insulin time set to 2 hours, Time in Range reached 78.8% without increasing hypoglycemia.

According to the release, these results are mirrored by the real-world evidence across Europe where the system has been approved since 2020 and is now available in 105 countries. "A lot can happen to blood sugars in the span of an hour or even just a few minutes, so we've designed our system for real life—the algorithm adapts to the user and helps compensate for everyday challenges that are quite common around mealtimes,” Dallara concluded. “We built in features informed by extensive customer feedback, and we're excited to deliver a system with ease of use at the forefront."

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Disclosures: Dallara is an employee of Medtronic. See press release for details.

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