Capillary Ketone Level and Future Ketoacidosis Risk in Patients With Type 1 Diabetes Using Sodium–Glucose Cotransporter Inhibitors
Authors' conclusion
Routine surveillance of capillary ketone levels in T1D using SGLTi may represent a DKA mitigation strategy and implies a potential threshold for continuous ketone monitoring.
Study context
- Population
- Empagliflozin-assigned participants with T1D in a trial with weekly fasted ketone levels, followed 6–12 months325 with events
- Participants
- 1,194 participants
- Comparison
- Maximum capillary ketone level in 28 days before diabetic ketoacidosis (DKA) or severe ketosis vs periods without an outcome
- Primary endpoint
- Subsequent adjudicated DKA or severe ketosis
- Follow-up
- 28-day periods over 6-12 months
Methodological detailsdiagnostic/prognostic accuracy, post hoc analysis of previously collected trial data, weekly fasted capillary ketone levels, 28-day periods
- Diagnostic/prognostic accuracy
- Post hoc analysis of previously collected trial data
- Weekly fasted capillary ketone levels
- 28-day periods
Primary result
As reported in the abstract
Prediction of DKA or severe ketosis by maximum ketone level in prior 28 days · 28 days before outcome
| Group | Sensitivity | Specificity | Diagnostic OR |
|---|---|---|---|
| Max ketone ≥0.8 mmol/L | 66.0% | 79.6% | 7.6 |
Max ketone ≥0.8 mmol/L
Sensitivity66.0%
Specificity79.6%
Diagnostic OR7.6
- AUC
- 0.76 (95% CI 0.71-0.82)
Safety
DKA and severe ketosis events · 6-12 months
- Participants with events
- 325
- DKA events
- 49
- Severe ketosis events
- 568
Original publication
Capillary Ketone Level and Future Ketoacidosis Risk in Patients With Type 1 Diabetes Using Sodium–Glucose Cotransporter Inhibitors. Diabetes Care. Published 23 April 2025. doi:10.
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