MiniMed 780G system demonstrates superiority over multiple daily injections with CGM for type 1 diabetes management at one-year in ADAPT study. Medtronic

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,(previously cited) 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 at the 2023 Advanced Technologies & Treatments for Diabetes (ATTD) Conference in Berlin.

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

"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 : Innovation of technology in type 1 diabetes has transformed the therapy and significantly improved outcomes and quality of life. Data presented at ATTD addressed one of the remaining hurdles of delivering a closed loop system — the ability to manage complex meals and exercise. Prof. Amir Tirosh, Sheba Medical Centre Israel, presented studies that evaluated simplified meal announcement approaches with the MiniMed 780G system, confirming it was able to handle unannounced meals up to 80 grams of carbohydrates, and that there was no deterioration in glycemic control when small amounts (up to 20 grams) of carbs were unannounced. In addition, he presented data that precise carb counting, often seen as a prerequisite for access to advanced diabetes technology, is not as important as once thought.

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 FDA for commercial approval.

See- "Effect of Tight Glycemic Control on Pancreatic Beta Cell Function in Newly Diagnosed Pediatric Type 1 Diabetes: A Randomized Clinical Trial"-Jennifer McVean, MD; Gregory P. Forlenza, MD; Roy W. Beck, MD, PhD; et, al; CLVer Study Group. JAMA. 2023; doi: 10.1001/jama.2023.2063.