Efficacy and safety of automated insulin delivery in children aged 2–6 years (LENNY): an open-label, multicentre, randomised, crossover trial
Primary result · TIR (70-180 mg/dL)Result — go to the resultAdjusted between-treatment difference 9.9 percentage points 95% CI 8.0–11.7Authors' conclusion
In children aged 2-6 years with type 1 diabetes, the TIR with the MiniMed 780G system in auto mode was non-inferior to that in manual+SBL mode. The significantly improved TIR and HbA1c in favour of auto mode could help prevent diabetes-related complications. Additionally, the observed safety profile in auto mode was acceptable.
Study context
- Population
- Children with T1D aged 2–6 years requiring ≥6 units of insulin/day, 12 hospitals in Finland, Italy, Slovenia and the UK; mean age 4.7 years (SD 1.2), 49% femalebegan study phase
- Participants
- 98 children
- Comparison
- Automated insulin delivery (AID) auto mode vs manual mode with suspend before low
- Primary endpoint
- Between-treatment difference in % TIR (70-180 mg/dL), least-squares mean difference adjusted for sequence and run-in TIR, assessed for non-inferiority (margin 7.5 percentage points)
- Follow-up
- 12-week periods
Methodological detailsopen-label, multicentre, non-inferiority (margin 7.5 percentage points), Recruitment March 24 to Sept 21, 2023, Sequences: AM-MM n=50 (two withdrawals), MM-AM n=48, 2-week run-in in manual+SBL, then 26-week study phase: 12-week auto mode, 2-week washout, 12-week manual+SBL (AM-MM) or reverse (MM-AM)
- Open-label
- Multicentre
- Non-inferiority (margin 7.5 percentage points)
- Recruitment March 24 to Sept 21, 2023
- Sequences: AM-MM n=50 (two withdrawals), MM-AM n=48
- 2-week run-in in manual+SBL, then 26-week study phase: 12-week auto mode, 2-week washout, 12-week manual+SBL (AM-MM) or reverse (MM-AM)
Primary result
TIR (70-180 mg/dL) · 12 weeks
Adjusted between-treatment difference
9.9 percentage points
95% CI 8.0–11.7
By group
Auto modevs Manual+SBL
adjusted between-treatment difference 9.9 percentage points (95% CI 8.0–11.7)
As reported in the abstract
Secondary outcomes
| Outcome | Auto mode | Manual+SBL | Between-treatment difference (percentage points) (95% CI) | |
|---|---|---|---|---|
| HbA1c · end of each 12-week periodIntention-to-treat · mean | 7.00% (SD 0.53) | 7.61% (SD 0.91) | −0.61 (−0.76 to −0.46) | |
| Mmol/mol | 53.0 (SD 5.8) | 59.7 (SD 9.9) | ||
| −1−0.500.5Difference, percentage points (linear scale) |
- HbA1c — Mean HbA1c in run-in phase
- 7.53% (SD 0.96; 58.8 mmol/mol [SD 10.5])
- HbA1c: non-inferiority (margin 0.4 percentage points) met with superiority for auto mode
Time in range (TIR) in run-in phase
- Mean TIR in run-in phase
- 58.1% (SD 14.3)
Safety
Serious adverse events
- Serious adverse events, total (all deemed unrelated to study device or procedure)
- 9
- During auto mode
- 5
- During manual+SBL mode
- 2
- During run-in
- 1
- During washout
- 1
- DKA during auto mode
- 1
Severe hypoglycaemia
- Severe hypoglycaemia events
- 0
Original publication
Efficacy and safety of automated insulin delivery in children aged 2–6 years (LENNY): an open-label, multicentre, randomised, crossover trial. Lancet Diabetes Endocrinol. Published 19 June 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →