Algorithm-Driven Initiation and Adaptation of Hybrid Closed-Loop in Young Children with Type 1 Diabetes: A Pilot Study
Authors' conclusion
Findings from this pilot study suggest that the use of AID with algorithm-driven initiation and adjustment of pump parameters is safe and effective in young children with type 1 diabetes.
Study context
- Population
- Children aged 2–6 years with T1D (age range 2.0–5.9 years)29 analysed
- Participants
- 32 children
- Comparison
- 8-week automated insulin delivery (AID) with algorithm-driven initiation and adjustment of pump settings vs baseline
- Outcome
- Safety: % time <54 mg/dL and >250 mg/dL, tested for noninferiority vs baseline; efficacy (hierarchical): % TIR 70-180 mg/dL, mean glucose, % time >250, <70 and <54 mg/dL
- Follow-up
- 8 weeks
Methodological detailssingle-group, comparison with baseline, noninferiority (safety endpoints), hierarchical testing (efficacy endpoints)
- Single-group
- Comparison with baseline
- Noninferiority (safety endpoints)
- Hierarchical testing (efficacy endpoints)
Main finding
As reported in the abstract
Primary safety and efficacy endpoints · 8-week follow-up
- AID follow-up vs Baseline: P < 0.001
- AID follow-up vs Baseline: P = 0.005
- AID follow-up vs Baseline: P = 0.003
- AID follow-up vs Baseline: P = 0.02
- AID follow-up vs Baseline: P = 0.34
Further findings
Comparison with similar cohort with expert pediatric endocrinologists modifying pump settings (same age range, n = 86)
- No difference vs expert-adjusted cohort
Investigator overrides of software recommendations
- Software recommendations overridden by investigators
- 15%
Safety
% time <54 mg/dL and >250 mg/dL (primary safety) · 8-week follow-up
- Noninferior vs baseline
- P < 0.001
- Noninferiority
Original publication
Algorithm-Driven Initiation and Adaptation of Hybrid Closed-Loop in Young Children with Type 1 Diabetes: A Pilot Study. Diabetes Technol Ther. Published 28 March 2025. doi:10.
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