A1 Refereed original research article in a scientific journal
Consistent efficacy and safety of automated insulin delivery in children aged 2–6 years: results from the LENNY trial continuation phase
Authors: 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.
Publisher: Elsevier
Publication year: 2025
Journal: Diabetes Research and Clinical Practice
Article number: 112934
Volume: 230
ISSN: 0168-8227
eISSN: 1872-8227
DOI: https://doi.org/10.1016/j.diabres.2025.112934
Publication's open availability at the time of reporting: Open Access
Publication channel's open availability : Partially Open Access publication channel
Web address : https://doi.org/10.1016/j.diabres.2025.112934
Self-archived copy’s web address: 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.
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Funding information in the publication:
The study was funded by Medtronic; Medtronic was responsible for the design and conduct of the study and the interpretation of results.
