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.

中文翻译：

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呼吸酮分析仪检测成人和儿童 1 型糖尿病酮症的准确性

客观的

评估呼吸酮分析仪检测成人和儿童 1 型糖尿病酮症的准确性。

研究设计与方法

这是一项概念验证、前瞻性研究，比较了呼吸酮分析仪和血酮计以检测酮症。

结果

分析了来自 19 名患有 1 型糖尿病的成人和儿童的总共 500 项测量值。在非禁食成人中，呼吸酮分析仪和血酮计结果之间存在显着关联（p = 0.0066），但在儿童中则没有（p = 0.4579）。在成人中，呼吸酮分析仪的 3.9 PPM 截止值使约登指数最大化，AUC 为 0.73。呼吸酮分析仪的这个临界值对检测酮症（血酮计中≥0.6 mmol/L）具有 94.7% 的灵敏度和 54.2% 的特异性。

结论

呼气酮分析仪可被视为一种非侵入性筛查工具，用于排除成人 1 型糖尿病患者的酮症。