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Background <p>Non-invasive breath-based glucose estimation has emerged as a potential alternative to invasive capillary blood glucose testing. However, preliminary validation against established glucose estimation methods is required before broader clinical applicability can be considered.</p> Objective <p>To evaluate the preliminary feasibility of a prototype breath analyser for non-invasive glucose estimation compared with capillary glucometer measurements under point-of-care conditions.</p> Methods <p>This cross-sectional pilot feasibility and method-comparison study included 76 adults recruited at a tertiary care teaching hospital in India. Paired capillary blood glucose (CBG) and breath-derived glucose measurements were obtained within a 2-min interval. Correlation analysis, Bland–Altman agreement analysis, Clarke Error Grid analysis, mean absolute relative difference (MARD), and exploratory receiver operating characteristic (ROC) analysis were performed.</p> Results <p>The mean capillary glucose and breath-derived glucose values were 107 ± 24.8&#xa0;mg/dL and 120 ± 26.2&#xa0;mg/dL, respectively. Breath-derived glucose estimates showed a moderate positive correlation with capillary glucometer values (Spearman’s <i>r</i> = 0.675, <i>p</i> &lt; 0.001). Bland–Altman analysis demonstrated a mean bias of + 14&#xa0;mg/dL with 95% limits of agreement from −19 to + 46&#xa0;mg/dL. The MARD was 14.24% (95% CI, 10.78–18.21). The Clarke Error Grid analysis demonstrated that &gt;99% of measurements were located within Zones A and B. Exploratory ROC analysis demonstrated an AUC of 0.95, although sensitivity remained moderate (70.6%).</p> Conclusions <p>Breath-based glucose estimation demonstrated preliminary feasibility compared with capillary glucometer measurements under point-of-care conditions. However, systematic overestimation and moderate sensitivity were observed. Further large-scale validation using laboratory reference glucose methods is required before potential clinical application can be determined.</p>

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Preliminary feasibility of non-invasive breath-based glucose estimation compared with capillary glucose measurement: a cross-sectional pilot study

  • 期刊论文

  • 发表日期：

    2026年7月16日

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  • Manjulata,
  • Ganashree Chitradurga Palaiah,
  • Sushil Kumar,
  • Tribhuwan Kumar

摘要

Background

Non-invasive breath-based glucose estimation has emerged as a potential alternative to invasive capillary blood glucose testing. However, preliminary validation against established glucose estimation methods is required before broader clinical applicability can be considered.

Objective

To evaluate the preliminary feasibility of a prototype breath analyser for non-invasive glucose estimation compared with capillary glucometer measurements under point-of-care conditions.

Methods

This cross-sectional pilot feasibility and method-comparison study included 76 adults recruited at a tertiary care teaching hospital in India. Paired capillary blood glucose (CBG) and breath-derived glucose measurements were obtained within a 2-min interval. Correlation analysis, Bland–Altman agreement analysis, Clarke Error Grid analysis, mean absolute relative difference (MARD), and exploratory receiver operating characteristic (ROC) analysis were performed.

Results

The mean capillary glucose and breath-derived glucose values were 107 ± 24.8 mg/dL and 120 ± 26.2 mg/dL, respectively. Breath-derived glucose estimates showed a moderate positive correlation with capillary glucometer values (Spearman’s r = 0.675, p < 0.001). Bland–Altman analysis demonstrated a mean bias of + 14 mg/dL with 95% limits of agreement from −19 to + 46 mg/dL. The MARD was 14.24% (95% CI, 10.78–18.21). The Clarke Error Grid analysis demonstrated that >99% of measurements were located within Zones A and B. Exploratory ROC analysis demonstrated an AUC of 0.95, although sensitivity remained moderate (70.6%).

Conclusions

Breath-based glucose estimation demonstrated preliminary feasibility compared with capillary glucometer measurements under point-of-care conditions. However, systematic overestimation and moderate sensitivity were observed. Further large-scale validation using laboratory reference glucose methods is required before potential clinical application can be determined.