FDA Finally OKs Latest MiniMed System for Type 1 Diabetes

The FDA approved Medtronic's latest MiniMed insulin pump system, the company announced late last week.

Indicated for individuals with type 1 diabetes ages 7 and older, the MiniMed 780G system pairs the fingerstick-free Guardian 4 sensor with SmartGuard technology. This makes it the first insulin pump system to be able to detect meals and subsequently provide automatic insulin adjustments every 5 minutes for both basal and bolus needs.

While this feature doesn't fully replace pre-meal boluses taken 15 to 20 minutes prior to eating, the technology is designed to adjust for when users occasionally forget to bolus or underestimate 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, executive vice president and president of Medtronic Diabetes, in a statement. "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."

Users of the MiniMed 780G system stayed within the SmartGuard mode 95% of the time, which can be turned on or off. Fingersticks are required to enter SmartGuard, as well as during manual mode.

The system has the lowest possible target glucose setting -- 100 mg/dL -- out of all automated insulin pump systems currently available. It also features an infusion set that can be worn for up to 7 days. Current infusion sets are typically worn for up to 3 days.

FDA approval comes 2 years after Medtronic first submitted the system for approval, but was delayed due to quality control issues detailed in a warning letter from the FDA in 2021. The issues were spotted during an inspection following a slew of recalls of earlier generation models of MiniMed systems. (The 780G system has been approved in Europe since 2020 and is already available in 105 countries.)

One of the trials underpinning the approval was the ADAPT study published in Lancet Diabetes & Endocrinology last September. In the 82-patient study, MiniMed 780G users saw a 1.54% drop in hemoglobin A1c (HbA1c), while those who remained on standard of care had only a 0.2% drop in HbA1c after 6 months.

Patients using the 780G system also spent significantly more time within target range -- between 70 and 180 mg/dL (70.6% vs 43.6%). Just over half (52.8%) of those using the system achieved a time-in-range of over 70% at 6 months versus only 7% of those on multiple daily injections with intermittently scanned continuous glucose monitoring.

No participants on standard of care were able to achieve an HbA1c below 7% after 6 months, whereas 27.8% of those using the 780G system did.

Medtronic said it will be taking pre-orders for the system starting mid-May with first shipments scheduled for late summer. MiniMed 770G users will be able to upgrade their device for free with a remote software update.

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