Medtronic appears to be circling ever closer to landing the long-awaited FDA clearance for its algorithm-equipped insulin pump—geographically, at least.
As of September, the MiniMed 780G system had been made available in more than 60 countries around the world, with the U.S. notably missing from the list. Latest to join is its neighbor to the north: Health Canada has now licensed the pump, Medtronic announced.
With that clearance, the device will begin rolling out across Canada next year. In the meantime, current users of the previous iteration of the pump, the MiniMed 770G, will be able to upgrade their devices with the new system’s software.
The MiniMed 780G is equipped with Medtronic’s SmartGuard technology, a hybrid closed-loop algorithm that analyzes readings from a user’s continuous glucose monitor—separate from the MiniMed device—and uses them to automatically adjust the insulin pump’s output to keep blood sugar levels within a preset range.
The system performs these checks every five minutes and can adjust both background and bolus doses of insulin. The latter option centers on “meal detection technology,” according to Laura Cameron, senior director of endocrinology at Medtronic Canada, potentially taking the burden off patients to calculate carbohydrates at mealtimes and tweak their own insulin doses accordingly.
All of the algorithm’s gathered data and adjustments can be monitored in real time through an accompanying smartphone app, which connects to the insulin pump via Bluetooth.
The system is indicated for people with Type 1 diabetes who are between the ages of 7 and 80, and who require a total dose of at least eight insulin units per day.
A recent study of the device pitted its automated, closed-loop system against a typical diabetes management setup that included multiple daily insulin injections and manual check-ins with a CGM. It focused on 82 participants who started the trial with average HbA1C levels above 8%.
After six months, those assigned to use the MiniMed 780G saw their blood sugar levels drop by an average of 1.4%, and more than a quarter of the group saw their HbA1C levels drop below 7%—a milestone that no one in the control group reached. Meanwhile, by the end of the study, those in the MiniMed group were found to be spending about 27% more time within their ideal glucose ranges than those in the control group.
Medtronic initially submitted the MiniMed 780G system for FDA approval in the spring of 2021—nearly a year after securing CE mark approval in Europe in mid-2020.
The U.S. sign-off has been slow to arrive, however, thanks in large part to the FDA’s discovery of quality control issues at the California headquarters of Medtronic’s diabetes business. A December 2021 letter from the agency outlined shortfalls it discovered at the Los Angeles-area facility in a routine inspection, prompting Medtronic to implement corrective actions and other process improvements to address the issues.
In an August call with investors, CEO Geoff Martha said, “We’re making good progress on our warning letter commitments. We’ve completed more than 90% of the actions we committed to the FDA. This represents substantial progress toward resolving the warning letter and preparing for reinspection.”