The aim of this study was to evaluate the newly developed non-invasive blood glucose system NIRLUS® (Near-Infra Red Light Ultra Sound; NIRLUS Engineering AG, Lübeck, Germany) under standardized conditions. Seventeen healthy men of normal weight (body mass index 22.4 ± 1.4 kg/m2 ), aged 18 to 45 years, were enrolled in this study. During an intravenous glucose tolerance test, blood glucose profiles were measured simultaneously using the NIRLUS system and a "gold standard" laboratory reference system. Correlation analysis revealed a strong association between NIRLUS and reference values (r = 0.934; P < 0.001). Subsequent Bland-Altman analysis showed a symmetric distribution (r = 0.047; P = 0.395), and 95.5% of the NIRLUS-reference pairs were within the difference (d) of d ± 2 SD. The median deviation of all paired NIRLUS-reference values was 0.5 mmol/L and the mean percent deviation was 11.5%. Error grid analysis showed that 93.6% of NIRLUS-reference pairs are located in the area A, and 6.4% in the area B. No data were allocated in the areas C to E. This proof-of-concept study demonstrates the reproducibility of accurate blood glucose measures obtained by NIRLUS as compared to a gold standard laboratory reference system. The technology of NIRLUS is an important step forward in the development of non-invasive glucose monitoring.

中文翻译：

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评价作为非侵入性血糖监测设备的近红外光超声系统。

这项研究的目的是在标准化条件下评估新开发的无创血糖系统NIRLUS®（近红外Ultra Sound； NIRLUS Engineering AG，德国吕贝克）。这项研究纳入了18名年龄在18至45岁之间，体重正常（体重指数22.4±1.4 kg / m2）的健康男性。在静脉葡萄糖耐量试验期间，使用NIRLUS系统和“黄金标准”实验室参考系统同时测量血糖分布。相关分析显示，NIRLUS与参考值之间有很强的关联性（r = 0.934； P <0.001）。随后的Bland-Altman分析显示出对称分布（r = 0.047； P = 0.395），并且95.5％的NIRLUS参照对在d±2 SD的差异（d）内。所有成对的NIRLUS参考值的中位数偏差为0.5 mmol / L，平均偏差百分比为11.5％。误差网格分析表明，93.6％的NIRLUS参照对位于区域A，区域6.4％在区域B。C至E区域未分配任何数据。与金标准实验室参考系统相比，通过NIRLUS获得的血糖测量值。NIRLUS技术是无创血糖监测技术发展的重要一步。这项概念验证研究证明了与金标准实验室参考系统相比，NIRLUS获得的准确血糖测量值具有可重复性。NIRLUS技术是无创血糖监测技术发展的重要一步。这项概念验证研究证明了与金标准实验室参考系统相比，NIRLUS获得的准确血糖测量值具有可重复性。NIRLUS技术是无创血糖监测技术发展的重要一步。