The Virtual Diabetes Control and Complications Trial #4: Relationship of HbA1c and Continuous Glucose Monitoring Metrics with Severe Hypoglycemic Events
Authors' conclusion
Hypoglycemia-focused CGM metrics reproduced by virtual CGM data from the DCCT were strongly associated with SH events, although the positive predictive value was low.
Study context
- Population
- Individuals with T1D in the Diabetes Control and Complications Trial (DCCT)
- Primary endpoint
- SH events in relation to HbA1c and CGM metrics
- Follow-up
- Within the subsequent 90 days
Methodological detailsvirtual continuous glucose monitoring (CGM) profiles generated by multistep machine-learning approach, Poisson regression models
- Virtual CGM profiles generated by multistep machine-learning approach
- Poisson regression models
Primary result
As reported in the abstract
SH events · subsequent 90 days
RR for severe hypoglycemia (SH) events per 1% increase in time-below-range (TBR)
1.23
95% CI 1.20–1.27
RR for SH events per 0.5% increase in level 2 hypoglycemia (glucose <54 mg/dL)
1.36
95% CI 1.30–1.43
Further findings
SH events per 0.5 SD change in TBR and level 2 hypoglycemia
- Similar pattern when assuming a 0.5 SD change in these metrics
PPV of TBR threshold >6% for SH events
- PPV of TBR >6% for SH events
- 13%
Original publication
The Virtual Diabetes Control and Complications Trial #4: Relationship of HbA1c and Continuous Glucose Monitoring Metrics with Severe Hypoglycemic Events. Diabetes Technol Ther. Published 16 March 2026. doi:10.
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