Efficacy and safety of hybrid closed-loop systems in children aged < 7 years with type 1 diabetes: a systematic review and meta-analysis of randomized controlled trials
Pooled result · Percentage of time in rangeResult — go to the resultMD 9.95 % 95% CI 7.8–12.09Authors' conclusion
The hybrid closed-loop system can effectively improve glycemic control in children under 7 years old with Type 1 diabetes without increasing the risk of adverse events.
Study context
- Population
- Children aged <7 years with T1D; PubMed, Cochrane Library, Embase, Web of Science to July 30, 2025
- Participants
- 274 children3 RCTs
- Comparison
- Hybrid closed-loop system vs conventional therapy
- Outcome
- Percentage of time in range
- Follow-up
- 3 months
Methodological detailsTwo investigators independently screened, extracted data and assessed risk of bias; meta-analysis in RevMan 5.4
- Two investigators independently screened, extracted data and assessed risk of bias; meta-analysis in RevMan 5.4
Pooled result
As reported in the abstract
MD
9.95 %
95% CI 7.8–12.09
P < 0.00001
Hybrid closed-loop systemvs Conventional therapy
MD 9.95 % (95% CI 7.8–12.09); P < 0.00001
Further pooled results
| Outcome | MD (%) (95% CI) | P value | |
|---|---|---|---|
| HbA1c · 3 months | −0.51 (−0.64 to −0.37) | P < 0.00001 | |
| Percentage of time below range | 0.56 (−0.13 to 1.25) | P = 0.11 | |
| −1−0.500.511.5Difference, % (linear scale) |
Safety
| Outcome | P value |
|---|---|
| Serious adverse events: DKA and severe hypoglycaemiaHybrid closed-loop system vs Conventional therapy | P = 0.50 |
| Serious adverse events: DKA and severe hypoglycaemiaHybrid closed-loop system vs Conventional therapy | P = 0.64 |
Serious adverse events: DKA and severe hypoglycaemia
- No statistically significant differences in risk of DKA and severe hypoglycemia
Original publication
Efficacy and safety of hybrid closed-loop systems in children aged < 7 years with type 1 diabetes: a systematic review and meta-analysis of randomized controlled trials. Pediatr Diabetes. Published 12 August 2026. doi:10.
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