A1 Vertaisarvioitu alkuperäisartikkeli tieteellisessä lehdessä
Consistent efficacy and safety of automated insulin delivery in children aged 2–6 years: results from the LENNY trial continuation phase
Tekijät: Dovc, K.; Tuomaala, Ak.; Kuusela, S.; Shetty, A.; Rabbone, I.; Tiberi, V.; Campbell, F.; Peters, C.; Ahomäki, R.; Zanfardino, A.; Sundaram, P.; Schiaffini, R.; Re, R.; Jullian, B.; di Piazza, F.; van den Heuvel, T.; Castaneda, J.; Cohen, O.
Kustantaja: Elsevier
Julkaisuvuosi: 2025
Lehti: Diabetes Research and Clinical Practice
Artikkelin numero: 112934
Vuosikerta: 230
ISSN: 0168-8227
eISSN: 1872-8227
DOI: https://doi.org/10.1016/j.diabres.2025.112934
Julkaisun avoimuus kirjaamishetkellä: Avoimesti saatavilla
Julkaisukanavan avoimuus : Osittain avoin julkaisukanava
Verkko-osoite: https://doi.org/10.1016/j.diabres.2025.112934
Rinnakkaistallenteen osoite: https://research.utu.fi/converis/portal/detail/Publication/505450417
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).
MethodsCwT1D 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).
Results91 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.
ConclusionIn CwT1D aged 2–6 years and TDD ≥ 6 units, the safety and good glycemic control from MM780G were sustained for ≥ 1 year and MM780G/SY was non-inferior to MM780/G4S.
Ladattava julkaisu This is an electronic reprint of the original article. |  |
Julkaisussa olevat rahoitustiedot:
The study was funded by Medtronic; Medtronic was responsible for the design and conduct of the study and the interpretation of results.
