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On April 21, 2023, Medtronic announced the long-awaited US approval of their MiniMed 780G System with Smart Guard Technology and the Guardian 4 Sensor, which has been available in Europe for nearly 3 years.
The US Food and Drug Administration (FDA) has approved the MiniMed 780G System for modifications to the SmartGuard Technology and for expanding indications for use to include the Guardian 4 Sensor.
Announced on April 21, 2023, the device, which has been available in Europe since 2020, boasts the strongest clinical outcomes and user experience data to date within the Medtronic family of pumps, according to the company’s announcement of the FDA’s approval.1
"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.1
In their statement announcing the approval, Medtronic pointed out the system is approved for users 7 years or older with type 1 diabetes and the company will being taking pre-orders on May 15, 2023, with first shipments planned for later this summer. Additionally, those using the MiniMed 770G System will be eligible to upgrade through a no-cost remote software upgrade.1
According to the FDA, the system is intended for continuous delivery of basal insulin at selectable rates. The FDA characterized the SmartGuard technology as having the ability to be programmed to automatically adjust insulin based on continuous glucose monitoring sensor vales and can suspend delivery if the value falls below or is predicted to fall below a predefined threshold.2
Billed as the having the lowest glucose target setting of any automated insulin pump, the MiniMed 780G system is the first insulin pump with meal detection technology featuring 5-minute auto corrections, according to Medtronic.1 Unlike the MiniMed 670/770G Systems, the MiniMed 780G system offers multiple glucose targets as compared to a single target.2
In a pivotal trial, use of the MiniMed 780G System was associated with a time in range of 70-180 mg/dL of 75% and an overall time below range of 1.8%. In their release, Medtronic pointed out the system provided even greater protection at night, with an overnight time in range of 82% and an overnight time below range of 1.5%.1
In the ADAPT study, which compared use of the system against multiple daily injections used with intermittently scanned continuous glucose monitoring, results indicated MiniMed780G System users experienced a 27.6% increase in time in range and 1.4% reduction in mean HbA1C compared to those using multiple daily injections and intermittently scanned continuous glucose monitoring.1
“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,” Dallara added.1