FDA Approves Medtronic’s New MiniMed Insulin Pump

Medtronic has received U.S. Food and Drug Administration (FDA) approval for its MiniMed 780G system with Guardian 4 sensor, which requires no fingersticks while in SmartGuard technology. The system was approved for type 1 diabetes patients aged seven and older.
 
According to Medtronic, this system is the only one with meal detection tech that offers auto-adjustments and corrections to sugar levels every five minutes, for both basal and bolus insulin. The system delivers insulin to account for when users forget to bolus or underestimates the number of carbs in a 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 told the press. “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.”
 
MiniMed 780G has the lowest possible glucose target setting (as low as 100 mg/dL) in an automated insulin pump, according to the company. It’s also the only pump with an infusion set that can be worn up to seven days. Its advanced materials can help reduce insulin preservative loss and maintain insulin flow and stability.
 
The new Guardian 4 continuous glucose monitoring (CGM) sensor, thanks to Medtronic’s SmartGuard technology, also requires no fingersticks.
 
“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.”
 
In the U.S. 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%5. The system offered greater protection at night with an overnight Time in Range of 82%, and overnight Time Below Range of 1.5%.
 
Medtronic also released one-year data on MiniMed 780G from its ADAPT study earlier this year.