One‐year effectiveness and safety in young children aged 2–6 years with type 1 diabetes using an automated insulin delivery system: A real‐world prospective cohort study
Authors' conclusion
One-year use of an AID system in young children with T1D was safe and associated with improved glycaemic management and reduced parental burden, with limited impact on time in hypoglycaemia and related parental fear.
Study context
- Population
- Children aged 2–6 years with T1D initiating automated insulin delivery (AID), 15 centres, October 2022–December 2023; mean age 4.2 ± 1.4 years, 56.4% girls, mean T1D duration 22.0 ± 13.0 months, 75.2% prior pump users
- Participants
- 149 children
- Exposure
- AID at 12 months vs start
- MiniMed 780Gn = 149
- Outcome
- Evolution of TIR (70-180 mg/dL) from start
- Follow-up
- 12 months after start
Methodological detailsreal-world, multicentre (15 centres), single-group, Data collected quarterly over 1 year during routine follow-up
- Real-world
- Multicentre (15 centres)
- Single-group
- Data collected quarterly over 1 year during routine follow-up
Main finding
As reported in the abstract
TIR (70-180 mg/dL) · start to 12 months
Time in range (TIR) at start
least-squares mean 56.8%
95% CI 54.4–59.2
TIR at 12 months
least-squares mean 66.6%
95% CI 64.7–68.5
Observational data: associations, not effects.
Further findings
| Outcome | P value |
|---|---|
| HbA1c · start to 12 months12 months vs Start | P < 0.001 |
| Time <70 mg/dL · start to 12 months12 months vs Start · remained stable | P = 0.172 |
| Parental diabetes burden (HAPPI-D) · start to 12 months12 months vs Start · less burden at 12 months | P = 0.001 |
- HbA1c — HbA1c at start
- 7.6% (95% CI 7.4-7.8)
- HbA1c — HbA1c at 12 months
- 7.2% (95% CI 7.1-7.4)
- Time <70 mg/dL — Time <70 mg/dL at start (4.2-5.8)
- 5.0%
- Time <70 mg/dL — Time <70 mg/dL at 12 months (3.9-5.3)
- 4.6%
- Parental diabetes burden (HAPPI-D) — HAPPI-D at start (21.7-24.0)
- 22.9 points
- Parental diabetes burden (HAPPI-D) — HAPPI-D at 12 months (20.5-22.8)
- 21.7 points
Parental fear of hypoglycaemia (HFS-Parent) · 12 months
- HFS-Parent scores did not change significantly
Safety
Hospitalisations · 1 year
- Hospitalisations for severe hypoglycaemic events
- 0
- Hospitalisations for DKA due to infusion set occlusion
- 1
Original publication
One‐year effectiveness and safety in young children aged 2–6 years with type 1 diabetes using an automated insulin delivery system: A real‐world prospective cohort study. Diabetes Obes Metab. Published 27 October 2025. doi:10.
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