RSP Systems, Sivlandvænget 27C, 5260 Odense, Denmark.
Institute for Diabetes Technology at University of Ulm, Lise-Meitner-Straße 8/2, 89081 Ulm, Germany.
ACS Sens. 2023 Mar 24;8(3):1272-1279. doi: 10.1021/acssensors.2c02756. Epub 2023 Mar 6.
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.
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。
