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利用共焦拉曼光谱技术对人体无创血糖测量的精确后校准预测。

Accurate Post-Calibration Predictions for Noninvasive Glucose Measurements in People Using Confocal Raman Spectroscopy.

机构信息

RSP Systems, Sivlandvænget 27C, 5260 Odense, Denmark.

Institute for Diabetes Technology at University of Ulm, Lise-Meitner-Straße 8/2, 89081 Ulm, Germany.

出版信息

ACS Sens. 2023 Mar 24;8(3):1272-1279. doi: 10.1021/acssensors.2c02756. Epub 2023 Mar 6.

Abstract

In diabetes prevention and care, invasiveness of glucose measurement impedes efficient therapy and hampers the identification of people at risk. Lack of calibration stability in non-invasive technology has confined the field to short-term proof of principle. Addressing this challenge, we demonstrate the first practical use of a Raman-based and portable non-invasive glucose monitoring device used for at least 15 days following calibration. In a home-based clinical study involving 160 subjects with diabetes, the largest of its kind to our knowledge, we find that the measurement accuracy is insensitive to age, sex, and skin color. A subset of subjects with type 2 diabetes highlights promising real-life results with 99.8% of measurements within A + B zones in the consensus error grid and a mean absolute relative difference of 14.3%. By overcoming the problem of calibration stability, we remove the lingering uncertainty about the practical use of non-invasive glucose monitoring, boding a new, non-invasive era in diabetes monitoring.

摘要

在糖尿病的预防和治疗中,葡萄糖测量的侵入性阻碍了有效的治疗,并阻碍了对高危人群的识别。非侵入性技术的校准稳定性不足,限制了该领域的短期原理验证。为了应对这一挑战,我们展示了首个实用的基于拉曼的便携式非侵入性血糖监测设备,该设备在经过校准后至少可以使用 15 天。在一项涉及 160 名糖尿病患者的家庭临床研究中,这是我们所知最大规模的同类研究,我们发现该测量的准确性不受年龄、性别和肤色的影响。一组 2 型糖尿病患者的结果具有很大的现实意义,在共识误差网格中的 A + B 区中,有 99.8%的测量值,平均绝对相对差异为 14.3%。通过克服校准稳定性的问题,我们消除了对非侵入性血糖监测实际应用的持续不确定性,预示着糖尿病监测的一个新的非侵入性时代的到来。

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