1901-LB: Safety and Glycemic Outcomes Using the MiniMed 780G System with a Disposable All-in-One Sensor with Transmitter

Objective: The present study assessed impact of the MiniMed™ 780G (MM780G) advanced hybrid closed-loop (AHCL) system on glycemic metrics and safety when used with the disposable all-in-one Simplera Sync™ sensor*. Methods: Youths (aged 7-17yrs) and adults (aged 18-80yrs) with T1D were enrolled in a single-arm study (24 U.S. sites) with a ~2-week run-in where HCL (Auto Basal only) or open-loop delivery was used. This was followed by a three-month study period with AHCL activated. Glycemic outcomes and insulin delivered during the last 6-7 weeks of the study, in which system settings were optimized at investigator’s discretion, were compared to those of the run-in. Impact of recommended optimal settings (ROS, 100 mg/dL glucose target [GT] with a 2hr active insulin time [AIT]), was explored. Results: All groups showed significantly increased TIR and TITR and significantly reduced TAR, compared to run-in (Table). Use of ROS further improved TIR, TITR and TAR, in part, due to >60% automated basal and bolus delivery. No episodes of device-related severe hypoglycemia or DKA occurred. Conclusion: Use of the MM780G with the Simplera Sync™ sensor was safe and demonstrated improved glycemic outcomes, compared with run-in, and compared to glycemic outcomes of the pivotal trials1,2. Similarly, a lower GT and shorter AIT were associated with a further increased TIR and reduced TAR and, here, an increased TITR.