Nearly two years after submitting its MiniMed 780G insulin delivery system to the FDA for clearance, Medtronic is still awaiting the agency’s nod—though not for a lack of evidence to back the technology.
In its latest data drop, the devicemaker presented the results of several studies of the insulin pump at the Advanced Technologies & Treatments for Diabetes (ATTD) conference in Berlin on Friday, all showcasing the pump’s potential to improve management of Type 1 diabetes.
The MiniMed 780G system is embedded with an algorithm, dubbed SmartGuard, that takes in blood sugar readings from a connected continuous glucose monitor like Medtronic’s Guardian 4 sensor. The SmartGuard technology is meant to create a hybrid closed-loop system, using the CGM data to automatically adjust the pump’s insulin doses throughout the day—all but freeing users from performing any adjustments themselves.
The system has already been greenlighted for use in dozens of countries around the world, but its application for U.S. clearance has been pending since the spring of 2021, delayed in part by quality control issues the FDA found at Medtronic’s diabetes business headquarters that year and which are still in the process of being resolved.
Chief among the newly presented studies, according to a Medtronic press release, was an update to its ADAPT trial. The study has followed a group of 82 adults with Type 1 diabetes who switched to the MiniMed automated closed-loop system from a previous approach that required them to perform multiple daily injections based on readings from a separate CGM.
In data published last fall, the study participants registered an average drop of 1.4% in their HbA1c levels six months after switching to Medtronic’s system. They also saw the average time they spent in an ideal glucose range per day grow by an average of more than 27%.
The study has since continued, and subsequent data presented Friday showed that those improvements stuck around for at least a year after the switch to the automated tech. From the six-month to the one-year mark, the participants saw their blood sugar levels creep back up by just 0.1% on average, while their time in the ideal glucose range dropped about 0.7%.
“These results further strengthen the case for us to move beyond the CGM-first paradigm to ensure patients experience these well-established clinical benefits of automated insulin delivery earlier at diagnosis,” Ohad Cohen, M.D., senior global medical affairs director of Medtronic Diabetes, said in the release. “The MiniMed 780G system is taking care of users in ways that individuals just aren’t able to with manual injections, even with the best of intentions, as there are so many variables that impact blood sugar levels on a daily basis.”
Also at the ATTD meeting, Medtronic shared the findings of a study focused on kids and teenagers newly diagnosed with Type 1 diabetes. The study, which was published in JAMA and dubbed CLVer, tracked the progress of 113 patients between the ages of 7 and 17 who were put on an intensive diabetes management plan shortly after diagnosis: either relying on an automated insulin delivery system—using an algorithm-equipped device from Medtronic or Tandem Diabetes Care—or performing manual injections based on real-time CGM data, the current standard of care.
After a year on their respective regimens, those using the automated systems achieved an average time in range of 78%, compared to 64% for the non-automated group, per Medtronic.
Echoing Cohen’s remarks, Jennifer McVean, M.D., senior medical affairs director of Medtronic Diabetes, suggested that the study results prove “the superiority of using automated insulin delivery systems as first-line treatment for Type 1 diabetes, rather than the standard stepwise approach of starting patients on a CGM first.”
Rounding out its data drop at the conference, Medtronic also shared findings related to the MiniMed 780G system’s ability to automatically detect when a user is eating. Typically, insulin pump users have to manually adjust their dosages at mealtimes after calculating the amount of carbohydrates consumed; removing that step brings the tech even closer to the holy grail of a completely hands-off diabetes management system.
The MiniMed 780G still works best if meals are announced, but one set of preliminary studies found that the device could automatically adjust to the unannounced intake of a limited amount of carbs with no changes in its glycemic control—but only up to about 20 grams of carbs, less than the amount in a single banana.
Medtronic has also begun testing the system for use with the Klue app, technology that the company acquired in 2019 and that uses a smartwatch to monitor hand gestures to automatically detect when a wearer is eating.
In an initial and very small study that combined MiniMed 780G and Klue and prohibited users from providing any manual carb calculations, the 17 participants achieved an average time in range of 80.6% during the five-day study period—results that Que Dallara, president of Medtronic Diabetes, called “very promising” in the company’s quest to create a “fully closed-loop system.”