FDA Approves Medtronic Insulin Pump with Meal Detection Technology

It provides automatic adjustments and corrections to sugar levels every 5 minutes for both basal (background) and bolus (mealtime) insulin needs.

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Medtronic said it received FDA) approval of its MiniMed 780G system with the Guardian 4 sensor requiring no fingersticks while in SmartGuard technology. 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 for both basal (background) and bolus (mealtime) insulin needs. 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," said Que Dallara, EVP and President of Medtronic Diabetes. "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."

The MiniMed 780G system features the lowest glucose target setting (as low as 100 mg/dL) in any automated insulin pump on the market and 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. It's 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. Combined with the new Guardian 4 sensor requiring no fingersticks with SmartGuard technology, the MiniMed 780G system delivers a user-friendly design with 94% of users saying they're satisfied with the impact the system has on their quality of life. Importantly, users also reported remaining in SmartGuard technology 95% of the time.

"My last two years on the MiniMed 780G system as part of the clinical trial have been incredible for me," said Terry Weland, a Medtronic customer for 25 years. "The system is so easy to use. I don't know anyone who's perfect at carb counting and there are times when you're not as on top of things as you'd like to be. I don't stress over my diabetes like I used to because I know the system has my back. I love that I can sync my sensor and infusion set changes to every 7 days, which streamlines my routine."

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