Safety and Glycemic Outcomes of the MiniMed 780G System with a Disposable All-in-One Sensor.

Abstract

Introduction: The present study assessed the impact of the disposable Simplera Sync™ sensor with the MiniMed™ 780G (MM780G) advanced hybrid closed-loop (AHCL) system on type 1 diabetes (T1D) glycemic metrics, insulin delivery, and safety. Materials and Methods: Youths (aged 7-17 years) and adults (aged 18-80 years) with T1D were enrolled in this single-arm, nonrandomized study at 24 sites in the United States. Participants began with an ∼2-week run-in period where hybrid closed-loop (HCL; auto basal only) or open-loop insulin delivery was used, followed by an ∼3-month study period with AHCL activated. Glycemic outcomes and insulin delivery during the last 6-7 weeks of the study, when settings were optimized at investigator's discretion, were compared with the run-in. Glycemic outcomes with the use of recommended optimal settings (ROS, 100 mg/dL glucose target with a 2-h active insulin time) were explored. Results: Time in automation was high (>93%) and mean time in range (TIR) increased from 54.4% ± 15.7% to 71.4% ± 9.9% (P < 0.001) in youths and from 66.5% ± 12.6% to 80.2% ± 8.1% (P < 0.001) in adults, primarily due to reduced time above range. Youths had a slight increase in time below range (TBR <70 mg/dL) from 1.6% ± 1.7% to 1.9% ± 1.4% (P < 0.001), while adults had no significant difference in TBR. For ROS users, TIR was 74.7% ± 9.3% in youths and 83.8% ± 7.4% in adults. Throughout the study ∼60% of total daily insulin dose was automated (auto basal and auto correction) in both cohorts. There were two cases of severe hypoglycemia and one episode of diabetic ketoacidosis (not related to the device). Conclusions: MM780G use with the Simplera Sync sensor is safe and demonstrated improved glycemic outcomes in both pediatric and adult participants with T1D, compared with the run-in period.