Medtronic has announced a series of US regulatory and reimbursement developments that expand access to its MiniMed 780G automated insulin delivery system for people living with type 1 diabetes and insulin-requiring type 2 diabetes. The updates include new Medicare coverage, additional FDA clearances and broader interoperability with continuous glucose monitoring technology.

The company confirmed that Medicare and Medicare Advantage beneficiaries can now access the MiniMed 780G system when paired with the Instinct sensor, manufactured by Abbott. The decision extends sensor choice for older adults using automated insulin delivery, alongside existing options that include the Guardian 4 and Simplera Sync sensors.

Que Dallara, executive vice president and president of Medtronic Diabetes, said the updates were aimed at increasing flexibility for people managing diabetes. Dallara said: “These milestones reflect our unwavering commitment to expanding access and giving individuals living with diabetes more choice in how they manage their condition.” Dallara added that broadening sensor and insulin options was intended to support easier mealtimes and more confident diabetes management.

The MiniMed 780G system automates insulin delivery and adjusts dosing every five minutes in response to glucose levels. Medtronic said access through Medicare will follow standard billing and fulfilment processes, subject to eligibility and coverage criteria, with distribution partners working to support timely delivery.

Alongside the Medicare decision, the FDA has cleared the MiniMed 780G system for use with ultra rapid-acting insulins Fiasp and Lyumjev. The clearance applies to people living with type 1 diabetes as well as those with insulin-requiring type 2 diabetes.

Ultra rapid-acting insulins are designed to enter the bloodstream more quickly than traditional rapid-acting formulations, particularly around mealtimes. Medtronic said the option to use these insulins alongside the system’s meal detection functionality may help reduce the impact of missed or delayed bolus dosing and allow therapy to be tailored to individual needs.

In a further regulatory update, the FDA has cleared the MiniMed 780G insulin pump as an alternate controller enabled device and the SmartGuard algorithm as an interoperable automated glycaemic controller for insulin-requiring type 2 diabetes. This enables integration of the system with the Instinct sensor for this patient population.

The clearance expands the use of automated insulin delivery in type 2 diabetes, where daily management often involves multiple injections, frequent glucose monitoring and complex meal planning. Medtronic said the system is designed to reduce treatment burden by automatically adjusting insulin delivery and responding to changes in glucose levels throughout the day.

Anders Carlson, associate executive director at the International Diabetes Center in Minneapolis, said the expanded clearance could benefit a broader group of patients. Carlson said: “I think anyone who requires insulin therapy to manage their diabetes, whether it’s type 1 or type 2 diabetes, can benefit from automated insulin delivery.” Carlson added that clearance of the system with the Instinct sensor for type 2 diabetes would allow more people to access technology that can support day-to-day diabetes management.

Medtronic said the MiniMed 780G system for insulin-requiring type 2 diabetes can now be ordered with the Instinct, Guardian 4 or Simplera Sync sensors. Availability of the Instinct sensor currently differs by diabetes type, with broader access expected following regulatory and reimbursement pathways.

The announcements reflect continued regulatory activity in automated insulin delivery and growing focus on interoperability, reimbursement and personalised diabetes management in the US healthcare system.