Performance of the MiniMed 780G System with the Guardian 4 Sensor-Impact on the First 1,570 Real-World Users

Diabetes(2022)

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摘要
Objective: Since 2021, the MiniMed™ 780G advanced hybrid closed-loop system with the non-adjunctive Guardian™ 4 sensor, that does not require calibration, has been commercially available in Europe. In this study, the real-world glycemic outcomes of the first 1,570 individuals using the system were evaluated. Methods: Analyses were based on data collected since November 2021 from consenting users (N=1,570) in 15 countries who had ≥days of sensor glucose (SG) data. Glycemic outcomes including the mean±SD of the glucose management indicator [GMI], SG, and 24-hour and nighttime percentage of time spent within 70-180mg/dL (TIR) , at <54mg/dL [TBR54], <70mg/dL [TBR70] and >180mg/dL [TAR180] were determined. The mean±SD of time spent in closed loop and the number of closed-loop exits/week were also assessed. Results: For 94±11% of time spent in closed loop, users had an SG of 153±18mg/dL, GMI of 6.96±0.41% and TIR of 73.5±10.7%. Their TBR54, TBR70 and TAR180 were 0.11±0.15%, 1.7±1.5% and 24.8±11.0%, respectively. During the night (12AM-6AM) , TIR was 81.5±12.8%, TBR54 was 0.08±0.20%, TBR70 was 1.1±1.7% and TAR180 was 17.5±12.9%. The number of closed-loop exits was 0.8±0.9/week. Conclusion: MiniMed™ 780G system use with the Guardian™ 4 sensor involved substantial time in closed loop and favorable glycemic control that aligned with the recommended international consensus for continuous glucose monitoring metrics. Disclosure J.Shin: Employee; Medtronic. A.Arrieta: Employee; Medtronic. J.Castañeda: Employee; Medtronic. T.L.Cordero: Employee; Medtronic, Medtronic. A.S.Rhinehart: Employee; Medtronic, Stock/Shareholder; Medtronic. R.A.Vigersky: Employee; Medtronic.
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关键词
guardian,sensor—impact,performance,real-world
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