Measuring glucose at the site of insulin delivery with a redox-mediated sensor.
Measuring glucose at the site of insulin delivery with a redox-mediated sensor.
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DOI：
10.1016/j.bios.2020.112221
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发表时间：
2020-10-01
影响因子：
12.6
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1型糖尿病患者的自动胰岛素输送系统依赖于精确的皮下葡萄糖传感器和输注套管，根据测量的葡萄糖输送胰岛素。将传感器与输注套管集成将通过减少插入皮下组织的设备数量提供实质性的好处。我们描述了传感器的化学和校准算法，以尽量减少胰岛素输送伪影的影响在一个新的葡萄糖传感插管。7名1型糖尿病患者接受了自动胰岛素输送，他们使用了两个传感套管，其中一个输送了速效胰岛素类似物，另一个输送了不含胰岛素的磷酸盐缓冲盐水（PBS）对照溶液。虽然在两种情况下都有一个小的伪像，随着体积的增加而增加，但通过整合大量液体输送后传感器值的曲线下面积来确定，传递胰岛素的传感插管与传递PBS的传感插管中的伪像之间没有差异（P=0.7）。研究发现，当液体量较大时，传感器从伪迹中恢复的时间比液体量较小时要长（10.3±8.5分钟vs. 41.2±78.3秒，P<0.05）。采用智能采样卡尔曼滤波平滑算法提高了传感器精度。当对所有传感器使用全点校准时，智能采样卡尔曼滤波器将平均绝对相对差从10.9%降低到9.5%，导致96.7%的数据点落在Clarke误差网格的A和B区域内。尽管有一个小的伪影，这可能是由于液体输送的稀释，但可以在同时输送胰岛素的插管中连续测量葡萄糖。
Automated insulin delivery systems for people with type 1 diabetes rely on an accurate subcutaneous glucose sensor and an infusion cannula that delivers insulin in response to measured glucose. Integrating the sensor with the infusion cannula would provide substantial benefit by reducing the number of devices inserted into subcutaneous tissue. We describe the sensor chemistry and a calibration algorithm to minimize impact of insulin delivery artifacts in a new glucose sensing cannula. Seven people with type 1 diabetes undergoing automated insulin delivery used two sensing cannulae whereby one delivered a rapidly-acting insulin analog and the other delivered a control phosphate buffered saline (PBS) solution with no insulin. While there was a small artifact in both conditions that increased for larger volumes, there was no difference between the artifacts in the sensing cannula delivering insulin compared with the sensing cannula delivering PBS as determined by integrating the area-under-the-curve of the sensor values following delivery of larger amounts of fluid (P=0.7). The time for the sensor to recover from the artifact was found to be longer for larger fluid amounts compared with smaller fluid amounts (10.3 ± 8.5 minutes vs. 41.2 ± 78.3 seconds, P<0.05). Using a smart-sampling Kalman filtering smoothing algorithm improved sensor accuracy. When using an all-point calibration on all sensors, the smart-sampling Kalman filter reduced the mean absolute relative difference from 10.9% to 9.5% and resulted in 96.7% of the data points falling within the A and B regions of the Clarke error grid. Despite a small artifact, which is likely due to dilution by fluid delivery, it is possible to continuously measure glucose in a cannula that simultaneously delivers insulin.