Accuracy of a breath ketone analyzer to detect ketosis in adults and children with type 1 diabetes.

Objective: To assess the accuracy of a breath ketone analyzer to detect ketosis in adults and children with type 1 diabetes.

Research Design And Methods: This is a proof-of-concept, prospective study comparing breath ketone analyzer and blood ketone meter to detect ketosis.

Results: A total of 500 measurements from 19 adults and children with type 1 diabetes were analyzed. There was a significant association between the breath ketone analyzer and blood ketone meter results in non-fasting adults (p = 0.0066), but not in children (p = 0.4579). In adults, a cut-off of 3.9 PPM on the breath ketone analyzer maximized the Youden Index with an AUC of 0.73. This cut-off for the breath ketone analyzer had 94.7% sensitivity and 54.2% specificity to detect ketosis (≥0.6 mmol/L in blood ketone meter).

Conclusions: The breath ketone analyzer may be considered as a non-invasive screening tool to rule out ketosis in adults with type 1 diabetes.