Assessing Time Below Range as a Predictor of Severe Hypoglycemia: Insights From Six Clinical Trials
Authors' conclusion
Baseline TBR1 and TBR2 had limited predictive value for SH. No threshold achieved strong discrimination, a finding that supports the need to integrate additional clinical factors for SH risk stratification.
Study context
- Population
- Individuals with T1D in six clinical trials; median age 4–43 years; 50–62% female sex; 83–96% White race
- Participants
- 1,433 individuals6 trials
- Comparison
- Baseline continuous glucose monitoring (CGM) TBR1 and TBR2 as predictors of severe hypoglycemia (SH)
- Outcome
- SH adverse events during follow-up predicted by baseline TBR1 and TBR2
- Follow-up
- follow-up
Methodological detailsprognostic accuracy study, stratified by sex, race and age group, ROC analysis
- Prognostic accuracy study
- Stratified by sex, race and age group
- ROC analysis
Pooled result
As reported in the abstract
Prediction of SH by baseline TBR
| Group | AUC | Sensitivity (1% to 5% cutoff) | Specificity |
|---|---|---|---|
| TBR2 | 0.62 (95% CI 0.55-0.69) | 48.9% to 18.2% | 75.9-95.0% |
| TBR1 | 0.65 (95% CI 0.58-0.71) | 81.8% to 44.3% | 29.6-77.7% |
AUC
TBR20.62 (95% CI 0.55-0.69)
TBR10.65 (95% CI 0.58-0.71)
Sensitivity (1% to 5% cutoff)
TBR248.9% to 18.2%
TBR181.8% to 44.3%
Specificity
TBR275.9-95.0%
TBR129.6-77.7%
Further pooled results
Baseline TBR2 in those who developed SH vs those who did not
- Slightly higher baseline TBR2 in those who developed SH
- 0.41% vs. 0.32%; P = 0.022
Baseline TBR1 in those who developed SH vs those who did not
- Slightly higher baseline TBR1 in those who developed SH
- 2.58% vs. 2.23%; P = 0.044
Baseline median time below range (TBR) across the six trials
- Median TBR2 range
- 0.1% to 0.7%
- Median TBR1 range
- 1.2% to 4.1%
Original publication
Assessing Time Below Range as a Predictor of Severe Hypoglycemia: Insights From Six Clinical Trials. Diabetes Care. Published 13 January 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →