Medtronic announces one-year data from ADAPT study of MiniMed 780G system

Medtronic announced one-year data from the ADAPT study, the first multi-national randomized controlled study comparing the performance of the MiniMed 780G advanced hybrid closed loop system against multiple daily injections of insulin with an intermittently scanned CGM. The study was done in adults 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 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 DiabetesConference in Berlin. Data from a second randomized controlled study sponsored by JDRF, called the CLVer Trial, showed that in youth 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 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. Innovation of technology in type 1 diabetes has transformed the therapy and significantly improved outcomes and quality of life. Data presented today 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 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. 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 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.