• 国家药监局综合司 国家卫生健康委办公厅
  • 国家药监局综合司 国家卫生健康委办公厅

Advances in Exhaled Breath Analysis for Diagnosis of Diabetic Ketoacidosis

Corresponding author: LIU Xuelan, lhlliuxuelan@nbu.edu.cn
DOI: 10.12201/bmr.202606.00012
Statement: This article is a preprint and has not been peer-reviewed. It reports new research that has yet to be evaluated and so should not be used to guide clinical practice.
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    Abstract: Diabetic ketoacidosis (DKA) is one of the most serious acute complications of diabetes mellitus, with its incidence continuing to rise globally. Current diagnosis relies mainly on blood and urine ketone testing, which has limitations including invasiveness and delayed results. Exhaled breath analysis(EBA), as an emerging non-invasive detection approach, can achieve rapid and real-time screening of DKA by detecting acetone and other volatile organic compounds (VOCs) in exhaled breath. In recent years, significant advances have been made in breath analysis technologies based on mass spectrometry, gas sensors, electronic noses, and artificial intelligence algorithms. Multiple clinical studies have confirmed a significant positive correlation between breath acetone and blood ketone levels, and portable sensor-based devices have demonstrated promising prospects in DKA diagnosis, therapeutic monitoring, and ketosis risk assessment associated with sodium-glucose cotransporter 2 (SGLT2) inhibitors. However, this field still faces challenges including lack of standardized breath collection protocols, significant inter-individual variability, insufficient large-scale multicenter clinical validation, and absence of regulatory-approved devices. This article reviews the biological basis of ketone body metabolism and breath acetone in DKA, detection technologies, AI-assisted algorithms, clinical research progress and limitations, aiming to provide references for non-invasive early diagnosis of DKA.

    Key words: Diabetic ketoacidosis; Exhaled breath analysis; Acetone; Biomarker; Gas sensor; Electronic nose

    Submit time: 5 June 2026

    Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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  • ID Submit time Number Download
    1 2026-05-14

    10.12201/bmr.202606.00012V1

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徐嘉明, LIU Xuelan. Advances in Exhaled Breath Analysis for Diagnosis of Diabetic Ketoacidosis. 2026. biomedRxiv.202606.00012

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