Consistent efficacy and safety of automated insulin delivery in children aged 2–6 years: results from the LENNY trial continuation phase
Authors' 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.
Study context
- Population
- Children aged 2–6 years with T1D who completed the initial LENNY study phase, after a 12–24-week period on MM780G/G4Senrolled in continuation phase
- Participants
- 91 children
- Comparison
- MM780G/SY vs MM780G/G4S
- Primary endpoint
- Between-arm difference in mean HbA1c (non-inferiority)
- Follow-up
- After the 12-week period
Methodological detailscontinuation phase of the LENNY trial, non-inferiority
- Continuation phase of the LENNY trial
- Non-inferiority
Primary result
HbA1c · 12 weeks
Estimated treatment effect
0.14 %
95 % CI - 0.03 to 0.31
By group
As reported in the abstract
Further findings
TIR · over 12 weeks · non-inferiority confirmed for TIR
HbA1c after initial 12-24-week period
- Mean ± SD HbA1c, all participants
- 7.16 ± 0.59 %
Original publication
Consistent efficacy and safety of automated insulin delivery in children aged 2–6 years: results from the LENNY trial continuation phase. Diabetes Res Clin Pract. Published 10 October 2025. doi:10.
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