20.500.12556/DiRROS-27780 Consistent efficacy and safety of automated insulin delivery in children aged 2–6 years results from the LENNY trial continuation phase Objective: The LENNY randomized trial (NCT05574062) demonstrated that the MiniMed 780G system with Guardian™ 4 sensor (MM780G/G4S) is safe and effective for young children with type 1 diabetes (CwT1D). The continuation phase objective was to evaluate MM780G when used for extended time and when used with the Simplera Sync™ sensor (MM780G/SY). Methods: CwT1D who completed the initial study phase underwent a 12–24-week period using MM780G/G4S (in Auto Mode), after which they were randomly allocated to either continue using the same set-up or switch to MM780G/SY (in Auto Mode) for 12 weeks. The primary endpoint was the between-arm difference in mean HbA1c after the 12-week period (non-inferiority). Results: 91 CwT1D were enrolled in the continuation phase. After the initial 12–24-week period, mean ± SD HbA1c was 7.16 ± 0.59 %. After the 12-week treatment period, mean ± SD HbA1c was 7.24 ± 0.64 % for MM780G/G4S and 7.30 ± 0.53 % for MM780G/SY (estimated treatment effect = 0.14 %, 95 % CI − 0.03 to 0.31 %). Over the 12 weeks, mean ± SD time-in-range (TIR) was 68.9 ± 8.6 % for MM780G/G4S and 69.7 ± 7.7 % for MM780G/SY. Non-inferiority was confirmed for HbA1c and TIR. Conclusion: In CwT1D aged 2–6 years and TDD ≥ 6, the safety and good glycemic control from MM780G were sustained for ≥ 1 year and MM780G/SY was non-inferior to MM780/G4S. type 1 diabetes automated insulin delivery young children time-in-range HbA1c true false true Angleški jezik Ni določen Neznano 2026-02-24 14:59:37 2026-02-24 14:59:37 2026-02-25 03:50:50 0000-00-00 00:00:00 2025 0 0 Nasl. z nasl. zaslona; Opis vira z dne 24. 10. 2025; str. 1-8 Vol. 230, [article no.] 112934 2025 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 616.379 1872-8227 10.1016/j.diabres.2025.112934 254607107 RAZ_Dovc_Klemen_2025.pdf RAZ_Dovc_Klemen_2025.pdf 1 E4C88D6188600E7037B8D004879452E2 f800a9379fceb276e5fec3441513ddd1afc09bea7b49f1dc177baff0b4c6b8ea 3925ab50-1189-11f1-9cb0-001a4af901a5 https://dirros.openscience.si/Dokument.php?lang=slv&id=40838 https://www.diabetesresearchclinicalpractice.com/article/S0168-8227(25)00948-9/fulltext 0 4e921adf-1189-11f1-9cb0-001a4af901a5 https://dirros.openscience.si/Dokument.php?lang=slv&id=40839 Univerzitetni klinični center Ljubljana 0 0 0