Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced one-year data from the ADAPT study (n=82), the first multi-national randomized controlled study comparing the performance of the MiniMed™ 780G advanced hybrid closed loop system1 (AHCL) against multiple daily injections (MDI) of insulin with an intermittently scanned CGM (isCGM).
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A second randomized controlled trial sponsored by JDRF also demonstrates superiority of automated insulin pump as first-in-line therapy for children with type 1 diabetes DUBLIN and BERLIN, Feb. 24, 2023 /PRNewswire/ -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced one-year data from the ADAPT study (n=82), the first multi-national randomized controlled study comparing the performance of the MiniMed™ 780G advanced hybrid closed loop system1 (AHCL) against multiple daily injections (MDI) of insulin with an intermittently scanned CGM (isCGM). The study was done in adults (18 years of age and older) not meeting glycemic targets. The initial 6-month results, published in The Lancet Diabetes & Endocrinology, showed AHCL system users experienced a 27.6% absolute increase in Time in Range (TIR) and 1.4% reduction in HbA1C compared to those on MDI + isCGM without increased time in hypoglycemia. These results were even greater overnight with a TIR increase of 30.2%. At the close of the 6-month study period, all participants on MDI + isCGM crossed over to the MiniMed 780G system. At one year, these significant improvements were reproduced in this cross-over group and sustained in those that started on AHCL therapy at the start of the trial. These latest results were presented today at the 2023 Advanced Technologies & Treatments for Diabetes (ATTD) Conference in Berlin. Significant Improvements in Clinical Outcomes with MiniMed 780G System
Long Term Maintained Clinical Outcomes with MiniMed 780G System
* Non-inferiority met (margin= 0.3); ✢ Non-inferiority met (margin= -6%). "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 Ohad Cohen, M.D., Senior Global Medical Affairs Director, 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." Data from a second randomized controlled study sponsored by JDRF, called the CLVer Trial, (n=113) showed that in youth (7 to17 years old) with newly-diagnosed type 1 diabetes, early intensive management, including use of an automated insulin delivery system, resulted in superior Time in Range of 78% compared to 64% Time in Range in the standard-care group (real-time CGM without automated insulin delivery) at one year. The CLVer Trial results were presented in a late-breaking clinical trial presentation at the ATTD Conference and concurrently published in the Journal of the American Medical Association (JAMA). "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 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." The Next Frontier in Therapy Management Meal management has been cited as one of the most challenging aspects of diabetes management as today, individuals need to calculate the number of carbs they're consuming and input it into their pump so the correct amount of insulin can be delivered (called "announcing a meal"). The MiniMed™ 780G system was designed to anticipate real life needs where carb counts aren't always exact and meal doses are often missed. As Medtronic advances its SmartGuard™ algorithm towards a fully closed loop system, the company is evaluating the use of its MiniMed 780G system integrated with its proprietary Klue smartwatch app which leverages hand gestures detected by a smartwatch to announce meals to the pump with the goal of eliminating manual meal announcements. Early data from a small single site study (n=17) showed users were able to maintain glycemic control similar to the current standard of care of manually announcing a meal in the pump and bolusing. The study evaluated the use of the MiniMed 780G system with the Klue app disabled while traditional carb counting and carb entry were completed at baseline. Following that, the app was enabled for five days, and carb counting was prohibited. This first study of this integrated system showed that it successfully handled test meals and drinks of varying caloric and carb size while maintaining good glycemic control with a Time in Range of 80.6% 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." The MiniMed 780G system integrated with the company's next-generation Guardian™ 4 Sensor is currently being reviewed by the Food and Drug Administration (FDA) for commercial approval and is currently investigational in the U.S. * The MiniMed 780G system is optimized for use with meal announcement.
About the Diabetes Business at Medtronic (www.medtronicdiabetes.com) About Medtronic Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Contacts
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Company Codes: NYSE:MDT |
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