Medtronic (NYSE:MDT) announced today that one-year data backs the use of its next-generation MiniMed 780G automated insulin pump.
The ADAPT study compared MiniMed 780 G against multiple daily injections of insulin with an intermittently scanned CGM. ADAPT, which included 82 subjects, marks the first multi-national, randomized controlled study comparing these methods. The study evaluated adults (18 years of age and older) not meeting glycemic targets.
Six-month data published last year demonstrated a 27.6% absolute increase in time in range and a 1.4% reduction in HbA1C for MiniMed 780G users. The data also demonstrated an overnight time in range increase of 30.2%. At the close of the six-month period, all participants in the multiple daily injection/CGM group crossed over to MiniMed 780G.
Medtronic said today that crossover study subjects reproduced these improvements, and those in the original MiniMed group sustained them at one year. The company presented results at the 2023 Advanced Technologies & Treatments for Diabetes (ATTD) Conference in Berlin.
“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,” said Dr. Ohad Cohen, senior global medical affairs director at Medtronic Diabetes. “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.”
Medtronic MiniMed 780G works well in the younger population, too
The company also presented data from a second randomized controlled study sponsored by JDRF. The CLVer trial of 113 youths between seven and 17 years old with newly diagnosed type 1 diabetes demonstrated further success for the advanced hybrid closed loop system.
Subjects demonstrated superior time in range of 78%. That compared to 64% in the standard care group (real-time CGM without automated insulin delivery) at one year.
“There is a growing body of clinical evidence demonstrating 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,” said Dr. Jennifer McVean, MD, senior medical affairs director, Medtronic Diabetes. “These results demonstrate patient success earlier in the course of their disease and across the age spectrum. Considering this compelling evidence, we’re committed to expanding access to our MiniMed 780G system so more people living with diabetes have an opportunity to improve short- and long-term health outcomes.”
Meal-time adjustment represents ‘the next frontier’
Data presented at ATTD addressed what Medtronic labeled a remaining hurdle of closed-loop automated insulin delivery. That comes in the form of managing complex meals and exercise.
Studies evaluating simplified meal announcement approaches with MiniMed 780G confirmed its ability to handle unannounced meals. It handled unannounced meals up to 80 grams of carbohydrates with no deterioration in glycemic control when small amounts (up to 20 grams) of carbs came in unannounced.
Medtronic also said that precise carb counting — considered a prerequisite for access to advanced diabetes technology — may not be as important as previously thought. Professor Amir Tirosh of Sheba Medical Centre Israel presented this data at ATTD.
According to Medtronic, it designed MiniMed 780G to anticipate real-life needs with inexact carb counts and missed meal doses. The company aims to progress its SmartGuard algorithm toward a fully closed-loop system but has other plans. Those include integrating MiniMed 780G with its proprietary Klue smartwatch app. Klue leverages hand gestures to announce meals to the pump, potentially eliminating manual meal announcements.
Early data from a small study of 17 users demonstrated maintained glycemic control similar to the current standard of care. The study evaluated MiniMed 780G with the Klue app disabled while traditional carb counting and entry were completed at baseline. The study then enabled the app for five days and prohibited carb counting. It showed that the integrated system successfully handled test meals and drinks of varying caloric and carb size. Users maintained good glycemic control with 80.6% time in range during the study period.
“Coupled with the real-world data we’re seeing across 104 countries where it’s commercially available, we’re confident our system addresses a significant unmet need while delivering on the ease of use so many of our customers have asked for,” said Que Dallara, EVP and president, Medtronic Diabetes. “We’re committed to advancing our SmartGuard algorithm towards a fully closed loop system and these early results on our next-generation platform integrated with Klue are very promising.”
How soon before we see the Medtronic MiniMed 780G in the U.S.?
MiniMed 780G remains investigational in the U.S. Combined with the next-generation Medtronic Guardian 4 sensor, the system is currently under FDA review.
In 2022, Medtronic CEO Geoff Martha cited uncertainty over approval timing for the company’s next-generation platforms. That includes MiniMed 780G with Guardian 4.
On the company’s most recent earnings call (Q3 2023), Martha said Medtronic remains engaged “in active review with the FDA” on its submission. Dallara said the company continues to expand access (across more than 90 markets now) and just awaits its latest entry into the U.S. market.
“We continue to be very optimistic about the progress we are seeing in the market,” Dallara explained. “The U.S. market needs new products. We all know that. But I think we are making forward movement on all aspects of the business.”
Issues arose for the business in December 2021 around an FDA warning letter. The letter highlighted inadequacies in specific medical device quality system requirements at its Diabetes business’ Northridge, California, facility. Martha said on the company’s third-quarter (2022) earnings call that it achieved 90% of the FDA’s action items related to the warning.
In September, the law firm of Kessler Topaz Meltzer & Check announced a lawsuit in the U.S. District in Minnesota. It claimed securities fraud over how Medtronic disclosed its insulin pump problems.