Use of Freestyle Libre 2.0 in children with type 1 diabetes mellitus and elevated HbA1c: Extension phase results after a 12‐week randomized controlled trial
Authors' conclusion
Extension phase outcomes with intermittently scanned continuous glucose monitoring (isCGM 2.0) in children with T1DM and elevated HbA1c showed a sustained reduction in hypoglycaemia and increased testing frequency at 24 weeks.
Study context
- Population
- Children aged 4–13 years with T1D and elevated HbA1c (7.5–12.2% [58–110 mmol/mol])66 completed extension
- Participants
- 100 children
- Comparison
- isCGM 2.0 continued vs isCGM 2.0 after SMBG control
Methodological details12-week extension after 12-week randomised controlled trial (RCT), Completed extension: 36/49 (73%) isCGM/isCGM and 30/51 (58.8%) Control/isCGM
- 12-week extension after 12-week RCT
- Completed extension: 36/49 (73%) isCGM/isCGM and 30/51 (58.8%) Control/isCGM
Primary result
As reported in the abstract
TBR <70 mg/dL (3.9 mmol/L) (TBR70) · 24 weeks
isCGM/isCGM: TBR70 baseline → 12 weeks → 24 weeks (p < 0.01 for both 12 and 24 weeks)
10.7 ± 11.3% → 2.8 ± 2.8% → 2.1 ± 2.4%
Control/isCGM: TBR70 12 weeks → 24 weeks (p < 0.01)
10.7 ± 7.4% → 2.9 ± 2.8%
Further findings
Daily glucose test frequency · 24 weeks
- isCGM/isCGM: baseline → 12 weeks → 24 weeks (p < 0.01 for both 12 and 24 weeks)
- 4.7 (2.7) → 10.7 (4.6) → 9.2 (4.7)
- Control/isCGM: 12 weeks → 24 weeks (p < 0.01)
- 3.2 (1.6) → 10.7 (5.4)
HbA1c and time in range (TIR) · 24 weeks
- HbA1c and TIR non-significant at 24 weeks in both groups
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Use of Freestyle Libre 2.0 in children with type 1 diabetes mellitus and elevated HbA1c: Extension phase results after a 12‐week randomized controlled trial. Diabet Med. Published 10 December 2024. doi:10.
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