UW Medicine Diabetes Institute, School of Medicine, University of Washington, Seattle, Washington, USA.
Division of Endocrinology, Diabetes, and Metabolism, Sheba Medical Center, Ramat Gan, Israel.
Diabetes Technol Ther. 2024 Sep;26(9):661-666. doi: 10.1089/dia.2024.0009. Epub 2024 May 17.
Since the introduction of continuous glucose monitoring (CGM) technology, developers have rigorously researched the feasibility of creating a noninvasive glucose monitoring device. In a recent pilot study, investigators reported a strong correlation between glucose values obtained from novel noninvasive monitoring device (GWave) values to venous and capillary glucose measurements. We investigated whether the level of accuracy observed in the pilot study could be reproduced in a larger cohort, using a smaller third-generation manufacturable device (Gen III GWave) containing a standardized sensor chip that can be mass produced for commercial use. The evaluation assessed concordance with capillary blood glucose, reproducibility between two Gen III devices, and accuracy during insulin-induced hypoglycemia. Assessment of samples from 75 subjects (type 2 diabetes, = 6; type 1 diabetes, = 28; nondiabetic pregnant subjects, = 10; and nondiabetic, = 31) showed that 97% of values were in Zone A with 3% in Zone B of the Clarke Error Grid, with a mean absolute relative difference of 6.7% from reference blood glucose. Comparison between two independent Gen III GWave devices demonstrated reproducibility between the sensors ( = 0.95), with 100% of values within Zone A. In the hypoglycemia assessment, measurements from the Gen III sensor tightly followed the capillary glucose measurements down to 42 mg/dL (2.3 mmol/L), whereas the CGM measurements from two different CGM only converged with the GWave and capillary glucose readings after 90 min of decreasing glucose levels. Our results show promise as potentially the first noninvasive technology. Future studies will focus on larger number of people in all glucose ranges. Real-time noninvasive blood glucose monitoring is possible using GWave technology.
自从连续血糖监测（CGM）技术问世以来，研发人员一直在严谨地研究开发非侵入性血糖监测设备的可行性。在最近的一项试点研究中，研究人员报告了新型无创监测设备（GWave）值与静脉和毛细血管血糖测量值之间的强相关性。我们研究了在更大的队列中是否可以复制试点研究中观察到的准确性水平，使用了一种更小的第三代可制造设备（Gen III GWave），其中包含可用于商业用途的标准化传感器芯片。该评估评估了与毛细血管血糖的一致性、两个 Gen III 设备之间的重现性以及在胰岛素诱导的低血糖期间的准确性。对 75 名受试者（2 型糖尿病，n=6；1 型糖尿病，n=28；非糖尿病孕妇，n=10；和非糖尿病，n=31）的样本进行评估表明，97%的数值在 Clarke 误差网格的 A 区，3%在 B 区，与参考血糖的平均绝对相对差异为 6.7%。两个独立的 Gen III GWave 设备之间的比较表明传感器之间具有重现性（r=0.95），100%的数值在 A 区。在低血糖评估中，Gen III 传感器的测量值与毛细血管血糖测量值紧密相关，直至 42mg/dL（2.3mmol/L），而两个不同 CGM 的 CGM 测量值仅在血糖水平下降 90 分钟后才与 GWave 和毛细血管血糖读数趋同。我们的结果显示出作为潜在的第一种非侵入性技术的希望。未来的研究将集中在所有血糖范围内的更多人。使用 GWave 技术可以实现实时非侵入性血糖监测。
