Capillary Ketone Level and Future Ketoacidosis Risk in Patients With Type 1 Diabetes Using Sodium-Glucose Cotransporter Inhibitors.

Abstract

We aimed to determine if routine capillary blood ketone testing on well days predicts future diabetic ketoacidosis (DKA) in type 1 diabetes (T1D) using sodium-glucose cotransporter inhibitors (SGLTi). We examined previously collected data from empagliflozin-assigned participants in a T1D trial that included weekly fasted ketone levels. Over 6-12 months, ketone levels were subdivided into 28-day periods, and the outcome was subsequent adjudicated DKA or severe ketosis. Among 1,194 participants, 325 had 49 DKA and 568 severe ketosis events. On-treatment maximum ketone levels were higher in the 28 days before an outcome compared with levels in those without an outcome, with area under receiver operating characteristic curve of 0.76 (95% CI 0.71-0.82). Maximum ketone level ≥0.8 mmol/L had sensitivity of 66.0%, specificity of 79.6%, and diagnostic odds ratio of 7.6. 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.