Effects of 12-Week Freestyle Libre 2.0 in Children with Type 1 Diabetes and Elevated HbA1c: A Multicenter Randomized Controlled Trial
Authors' conclusion
For children aged 4-13 years with elevated Hba1c isCGM led to improvements in glucose testing frequency and reduced time below range. However, isCGM did not translate into reducing Hba1c or psychosocial outcomes compared to usual care over 12-weeks.
Study context
- Population
- Children aged 4–13 years (mean 10.9 ± 2.3 years) with established T1D, naive to intermittently scanned continuous glucose monitoring (isCGM), with elevated HbA1c 7.5%-12.2% [58–110 mmol/mol] (mean 9.05 (1.3)%)
- Participants
- 100 children
- Comparison
- isCGM vs SMBG
- isCGMn = 49
- SMBGn = 51reference
- Primary endpoint
- Difference in change of HbA1c from baseline
- Follow-up
- 12 weeks
Methodological detailsmulticentre, parallel-arm
- Multicentre
- Parallel-arm
Primary result
As reported in the abstract
Change in HbA1c from baseline
No evidence of a difference between groups for change in HbA1c
0.23
95% CI −0.21 to 0.67P = 0.3
Further findings
| Outcome | Estimate | P value |
|---|---|---|
| Glucose-monitoring frequencyIncreased with isCGM | increase +4.89 /day (95% CI 2.97–6.81) | P < 0.001 |
| Percent TBR <3.9 mmol/LReported as reduced with isCGM | −6.4 % (CI 10.6 to −4.2) | P < 0.001 |
Parent and Child psychosocial scores · 12 weeks
- No differences in within-group changes for Parent or Child psychosocial scores
Original publication
Effects of 12-Week Freestyle Libre 2.0 in Children with Type 1 Diabetes and Elevated HbA1c: A Multicenter Randomized Controlled Trial. Diabetes Technol Ther. Published 20 October 2023. doi:10.
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