Time below range alone is insufficient to identify severe hypoglycaemia risk in type 1 diabetes—the critical role of hypoglycaemia awareness: results from the SFDT1 study
Authors' conclusion
TBR alone is not discriminative for high-risk SHE but combining TBR with hypoglycaemia awareness status identifies those at the highest risk for both TBR70 and TBR54.
Study context
- Population
- Adults with T1D using CGM in the SFDT1 study; mean ± SD age 41.6 ± 13.3 years, 53.8% female, HbA1c 57.2 ± 10.9 mmol/mol (7.4 ± 1.0%)
- Participants
- 848 CGM users
- Exposure
- Time below range (TBR) categories combined with hypoglycaemia awareness status
- Outcome
- Self-reported SHE; association with TBR70/TBR54 and modification by IAH (Gold Score)
- Follow-up
- 12 months after inclusion
Methodological detailsmulticentre
- Multicentre
Main finding
As reported in the abstract
12 months
Each group vs TBR70 ≤1% and no IAHOdds ratio (95% CI)
TBR70 >6% and IAHonly significant combination
3.32(1.40–7.82)
TBR54≥1% and IAHonly combination with increased risk
2.99(1.46–5.92)
- One-year incidence of severe hypoglycaemia events (SHE)
- 11.7%
- SHE incidence, TBR70 ≤1%
- 12.1%
- SHE incidence, TBR70 1.1-3.9%
- 10.2%
- SHE incidence, TBR70 4-6%
- 10.6%
- SHE incidence, TBR70 >6%
- 14.6%
- SHE incidence, TBR54 <1%
- 11.0%
- SHE incidence, TBR54 ≥1%
- 13.3%
Observational data: associations, not effects.
Further findings
Spline analysis of SHE risk across TBR70
- Low, stable SHE risk across TBR70 without impaired awareness of hypoglycaemia (IAH); non-linear pattern only with IAH
Original publication
Time below range alone is insufficient to identify severe hypoglycaemia risk in type 1 diabetes—the critical role of hypoglycaemia awareness: results from the SFDT1 study. Diabetologia. Published 9 September 2025. doi:10.
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