The FDA has approved an automated insulin pump that can offer real time insulin corrections, especially around mealtimes, for people living with type 1 diabetes.
According to a press release, medical technology company Medtronic has received FDA approval for its MiniMed 780G system. The system incorporates the company's Guardian 4 sensor and utilizes SmartGuard technology to allow continuous monitoring of blood sugar levels without the need for fingersticks, with the added benefit of meal detection technology that adjusts and corrects sugar levels every five minutes for both basal and bolus insulin needs. Que Dallara, EVP and President of Medtronic Diabetes, explained mealtimes are one of the biggest challenges for people with type 1 diabetes, and claims that, with the MiniMed 780G, it no longer has to be. The system has been approved for users seven years old and above with type 1 diabetes.
"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," Dallara said, according to the press release. "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. We built in features informed by extensive customer feedback and we're excited to deliver a system with ease of use at the forefront."
According to Medtronic, the MiniMed 780G system has the lowest glucose target setting of any automated insulin pump, more similar to the average glucose level of a non-diabetic person and provides automatic basal insulin adjustments and autocorrections to this target. Additionally, the pump is the only one that features an infusion set that can be worn for up to seven days and is made of advanced materials to reduce insulin preservative loss and minimize the risk of infusion set occlusion. The user-friendly design has been well received, with 94% of users satisfied with the system's impact on their quality of life, and 95% of users remaining in SmartGuard technology.
During the U.S. clinical trial of the MiniMed 780G system, users experiences 75% Time in Range (blood sugar between 70-180 mg/dl) and 1.8% Time Below Average, according to the press release. The system provided even better protection at night, with overnight Time in Range at 82% and Time Below Range at 1.5%. These results mirror real-world evidence across Europe, as the MiniMed 780G system has been approved there since 2020 and is available across 105 countries.
