Diabetes is a metabolic condition that is exponentially increasing worldwide. Current monitoring methods for diabetes are invasive, painful, and expensive. Herein, we present the first multipatient clinical trial that demonstrates clearly that tear fluid may be a valuable marker for systemic glucose measurements. The NovioSense Glucose Sensor, worn under the lower eye lid (inferior conjunctival fornix), is reported to continuously measure glucose levels in the basal tear fluid with good correlation to blood glucose values, showing clear clinical feasibility in both animals and humans. Furthermore, the polysaccharide coated device previously reported by our laboratory when worn, does not induce pain or irritation. In a phase II clinical trial, six patients with type 1 Diabetes Mellitus were enrolled and the capability of the device to measure glucose in the tear fluid was evaluated. The NovioSense Glucose Sensor gives a stable signal and the results correlate well to blood glucose values obtained from finger-prick measurements determined by consensus error grid analysis.

中文翻译：

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使用无创生物传感器检测泪液葡萄糖作为使用生物聚合物涂层治疗糖尿病的痛手指刺的替代方法的临床证据。

糖尿病是全球范围内呈指数增长的代谢疾病。当前的糖尿病监测方法是侵入性的，痛苦的且昂贵的。在这里，我们提出了第一个多患者临床试验，该试验清楚地证明了泪液可能是进行全身性葡萄糖测量的有价值的标志物。据报道，戴在下眼睑（结膜下穹ni下）下方的NovioSense葡萄糖传感器可连续测量基底泪液中的葡萄糖水平，并与血糖值具有良好的相关性，在动物和人类中均显示出明确的临床可行性。此外，我们实验室先前报道的多糖涂层设备在佩戴时不会引起疼痛或刺激。在II期临床试验中，招募了六名1型糖尿病患者，并评估了该设备测量泪液中葡萄糖的能力。NovioSense葡萄糖传感器可提供稳定的信号，其结果与通过共识误差网格分析确定的手指点刺测量获得的血糖值具有良好的相关性。