| Naslov: | Consistent efficacy and safety of automated insulin delivery in children aged 2–6 years : results from the LENNY trial continuation phase |
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| 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 - Predstavitvena datoteka, prenos (785,96 KB) MD5: E4C88D6188600E7037B8D004879452E2
URL - Izvorni URL, za dostop obiščite https://www.diabetesresearchclinicalpractice.com/article/S0168-8227(25)00948-9/fulltext
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| Jezik: | Angleški jezik |
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| Tipologija: | 1.01 - Izvirni znanstveni članek |
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| Organizacija: | UKC LJ - Univerzitetni klinični center Ljubljana
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| 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. |
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| Ključne besede: | type 1 diabetes, automated insulin delivery, young children, time-in-range, HbA1c |
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| Status publikacije: | Objavljeno |
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| Verzija publikacije: | Objavljena publikacija |
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| Leto izida: | 2025 |
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| Št. strani: | str. 1-8 |
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| Številčenje: | Vol. 230, [article no.] 112934 |
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| PID: | 20.500.12556/DiRROS-27780  |
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| UDK: | 616.379 |
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| ISSN pri članku: | 1872-8227 |
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| DOI: | 10.1016/j.diabres.2025.112934  |
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| COBISS.SI-ID: | 254607107  |
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| Opomba: | Nasl. z nasl. zaslona;
Opis vira z dne 24. 10. 2025;
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| Datum objave v DiRROS: | 24.02.2026 |
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| Število ogledov: | 34 |
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| Število prenosov: | 17 |
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| Metapodatki: |  |
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