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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All Authors
Dovc, K.
Tuomaala, A.
Kuusela, S.
Shetty, A.
Rabbone, I.
Tiberi, V.
Campbell, F.
Peters, C.
Ahomaki, R.
Zanfardino, A.
LTHT Author
Campbell, Fiona M
LTHT Department
Leeds Children's Hospital
Children & Young People's Diabetes
Children & Young People's Diabetes
Non Medic
Publication Date
2025
Item Type
Journal Article
Randomised Controlled Trial
Randomised Controlled Trial
Language
Subject
Subject Headings
Abstract
OBJECTIVE: The LENNY randomized trial (NCT05574062) demonstrated that the MiniMed 780G system with Guardian TM 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 TM 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.
Journal
Diabetes Research & Clinical Practice