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Naslov:Consistent efficacy and safety of automated insulin delivery in children aged 2–6 years : results from the LENNY trial continuation phase
Avtorji:ID Dovč, Klemen (Avtor)
ID Tuomaala, Anna-Kaisa (Avtor)
ID Kuusela, Salla (Avtor)
ID Shetty, Ambika (Avtor)
ID Rabbone, Ivana (Avtor)
ID Tiberi, V. (Avtor)
ID Campbell, Fiona (Avtor)
ID Peters, Catherine (Avtor), et al.
Datoteke:.pdf PDF - Predstavitvena datoteka, prenos (785,96 KB)
MD5: E4C88D6188600E7037B8D004879452E2
 
URL URL - Izvorni URL, za dostop obiščite https://www.diabetesresearchclinicalpractice.com/article/S0168-8227(25)00948-9/fulltext
 
Jezik:Angleški jezik
Tipologija:1.01 - Izvirni znanstveni članek
Organizacija:Logo UKC LJ - Univerzitetni klinični center Ljubljana
Povzetek: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.
Ključne besede:type 1 diabetes, automated insulin delivery, young children, time-in-range, HbA1c
Status publikacije:Objavljeno
Verzija publikacije:Objavljena publikacija
Leto izida:2025
Št. strani:str. 1-8
Številčenje:Vol. 230, [article no.] 112934
PID:20.500.12556/DiRROS-27780 Novo okno
UDK:616.379
ISSN pri članku:1872-8227
DOI:10.1016/j.diabres.2025.112934 Novo okno
COBISS.SI-ID:254607107 Novo okno
Opomba:Nasl. z nasl. zaslona; Opis vira z dne 24. 10. 2025;
Datum objave v DiRROS:24.02.2026
Število ogledov:34
Število prenosov:17
Metapodatki:XML DC-XML DC-RDF
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Gradivo je del revije

Naslov:Diabetes research and clinical practice
Založnik:Elsevier
ISSN:1872-8227
COBISS.SI-ID:23224837 Novo okno

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