Haaglanden Medical Centre, The Hague, The Netherlands.
NovioSense B.V., NovioTech Campus, Nijmegen, The Netherlands.
J Diabetes Sci Technol. 2021 Nov;15(6):1320-1325. doi: 10.1177/1932296820964844. Epub 2020 Oct 23.
We recently published the results of a pilot study measuring glucose in tear fluid. We now show the results of an additional 24 patients.
Twenty-four subjects were recruited from Haaglanden Diabetes Centre. The patients reported in a fasting state and were given a meal with half the usual dose of insulin during the test. The device was applied under the lower eyelid. Glucose levels from capillary blood and interstitial fluid with a flash glucose measurement device were recorded every 15 minutes; the current from the tear glucose sensor was recorded continuously. The eye surface and tolerability were regularly checked. A calibration algorithm to convert tear glucose to blood values was built using a neural network regression model and validated.
No adverse events were attributed to the sensor coil placed under the lower eyelid. The mean absolute relative difference for the 24-patient subset was 16.7 (after 6 hours total time in the eye). The median absolute relative difference was 13.3. Compared to published data from Abbott (15.7 on day 1), the present device is comparable to Libre, considering that the device was allowed only one hour of equilibration time before the measurements were made.
The NovioSense Tear glucose sensor measures blood glucose values with an acceptable accuracy and may become a good alternative to invasive devices.
我们最近发表了一项测量泪液中葡萄糖的初步研究结果。现在，我们展示了另外 24 名患者的结果。
从哈格灵恩糖尿病中心招募了 24 名受试者。这些患者在空腹状态下报告，并在测试期间给予常规剂量胰岛素的一半的餐食。设备被应用于下眼睑下。使用瞬态葡萄糖测量设备记录毛细血管血液和间质液中的葡萄糖水平，每 15 分钟记录一次；连续记录泪液葡萄糖传感器的电流。定期检查眼睛表面和耐受性。使用神经网络回归模型构建了一种将泪液葡萄糖转换为血液值的校准算法，并对其进行了验证。
放置在下眼睑下的传感器线圈没有引起任何不良反应。24 名患者亚组的平均绝对相对差异为 16.7（总共在眼睛中 6 小时）。中位数绝对相对差异为 13.3。与 Abbott 的已发表数据（第 1 天 15.7）相比，考虑到测量前仅允许设备平衡 1 小时，本设备与 Libre 相当。
NovioSense 泪液葡萄糖传感器以可接受的准确性测量血糖值，可能成为侵入性设备的良好替代品。
