Continuous Ketone Monitoring in Diabetic Ketoacidosis: Prospective Multicenter Method-Comparison and Feasibility Study

Introduction: Continuous ketone monitoring (CKM) could optimize diabetic ketoacidosis (DKA) treatment by monitoring beta-hydroxybutyrate (BOHB) continuously and minimally invasively. However, data on the agreement between interstitial and venous BOHB during DKA is lacking. Our objectives were to assess the feasibility of CKM during DKA and the agreement between interstitial and venous BOHB. Methods: This was a prospective multicenter method-comparison study conducted at two U.S. emergency departments. Adults (>18 years) in DKA were included. BOHB was measured via SiBio CKM and compared with simultaneously collected venous BOHB every 2 h during DKA treatment. Following DKA resolution, study staff removed CKM and assessed for complications. The primary outcome was level of agreement via Bland–Altman analysis between simultaneously collected CKM and venous BOHB values. Additional outcomes included correlation ( r ) between concurrent CKM and venous BOHB values, first detection of DKA resolution, and feasibility (uncomplicated application and removal of CKM). Results: Thirty-four patients were enrolled, with a mean age of 40.8 years, 56% male, 50% Black, 79% type I diabetes, and mean presenting BOHB 7.0 mmol/L (range 2.5–13.5). We analyzed 164 paired CKM and venous BOHB values (mean [standard deviation (SD)] paired values per patient: 4.8 [3.8], range 1–16). Bland–Altman analysis found the average difference between CKM and venous BOHB was −0.38 mmol/L (95% confidence interval [CI] −1.63, 0.88). CKM values were strongly correlated with venous BOHB ( r = 0.96, p < 0.001). The CKM value was lower than venous for 79% of paired values. DKA resolution was detected 55 min earlier (mean, 95% CI 26–84, p = 0.001) via CKM than standard care. No device-related complications occurred, and CKM application and removal were well tolerated by all patients. Conclusion: CKM during DKA treatment was feasible, provided clinically accurate BOHB readings, and detected DKA resolution earlier than standard care. CKM-guided DKA treatment is a promising strategy with the potential to improve the quality and value of DKA care.