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

Abstract

To assess the accuracy of a breath ketone analyzer to detect ketosis in adults and children with type 1 diabetes. This is a proof-of-concept, prospective study comparing breath ketone analyzer and blood ketone meter to detect ketosis. 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 (≥0.6mmol/L in blood ketone meter). The breath ketone analyzer may be considered as a non-invasive screening tool to rule out ketosis in adults with type 1 diabetes.