Medtronic announced that the US Food and Drug Administration (FDA) has approved its MiniMed insulin pump system. The MiniMed 780G system is intended for individuals with type 1 diabetes who are over the age of seven. The new system uses the Guardian 4 sensor with SmartGuard technology, which allows it to detect meals and subsequently provide automatic insulin adjustments every five minutes for basal and bolus needs. The MiniMed 780G system is the first insulin pump system that can do this. The algorithm adapts to the user and compensates for everyday challenges that are quite common around mealtimes.
Features and Benefits
The MiniMed 780G system has several features that set it apart from other automated insulin pump systems currently available. It has the lowest possible target glucose setting at 100 mg/dL. The system also has an infusion set that can be worn for up to seven days, which is longer than current infusion sets that are typically worn for up to three days. Fingersticks are required to enter SmartGuard and during manual mode.
According to Que Dallara, Executive Vice President and President of Medtronic 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.”
The ADAPT study published in Lancet Diabetes & Endocrinology last September underpins the approval. The study found that MiniMed 780G users saw a 1.54% drop in hemoglobin A1c (HbA1c), while those who remained on the standard of care had only a 0.2% drop in HbA1c after six months. Patients using the 780G system also spent significantly more time within the target range of between 70 and 180 mg/dL (70.6% vs 43.6%). Over half of those using the system achieved a time-in-range of over 70% at six months versus only 7% of those on multiple daily injections with intermittently scanned continuous glucose monitoring.
FDA approval comes two 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.
Medtronic said it would take 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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