Diabetes research and clinical practice · 2025
Consistent efficacy and safety of automated insulin delivery in children aged 2-6 years: results from the LENNY trial continuation phase.
СтатьяРандомизированное исследованиеEquivalence TrialНазвание и аннотация: Перевод пока не подготовлен
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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
Аннотация
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 units, the safety and good glycemic control from MM780G were sustained for ≥ 1 year and MM780G/SY was non-inferior to MM780/G4S.
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 units, the safety and good glycemic control from MM780G were sustained for ≥ 1 year and MM780G/SY was non-inferior to MM780/G4S.