Mondal Himel, Biri Sairavi Kiran, Pipil Neha, Mondal Shaikat
Department of Physiology, All India Institute of Medical Sciences, Deoghar, Jharkhand, India.
Department of Biochemistry, Phulo Jhano Medical College, Dumka, Jharkhand, India.
Indian J Endocrinol Metab. 2024 Jan-Feb;28(1):60-64. doi: 10.4103/ijem.ijem_36_23. Epub 2024 Feb 26.
Patients with diabetes mellitus monitor their blood glucose at home with monitors that require a drop of blood or use a continuous glucose monitoring device that implants a small needle in the body. However, both cause discomfort to the patients which may inhibit them for regular blood glucose checks. Photoplethysmogram (PPG) sensing technology is an approach for non-invasive blood glucose measurement and PPG sensors can be used to predict hypoglycaemic episodes. InChcek is a PPG-based non-invasive glucose monitor. However, its accuracy has not been checked yet. Hence, this study aimed to evaluate the accuracy of InCheck, a non-invasive glucose monitor for the estimation of blood glucose.
In a tertiary care hospital, patients who came for blood glucose estimation were tested for blood glucose non-invasively on the InCheck device and then by the laboratory method (glucose oxidase-peroxidase). These two readings were compared. We used International Organization for Standardization (ISO) 15197:2013 (95% of values should be within ± 15 mg/dL of reference reading if reference glucose <100 mg/dL or within ± 15% of reference reading if reference glucose ≥100 mg/dL and 99% of the values should be within zones A and B in consensus error grid), and Surveillance Error Grid for analyzing the accuracy.
A total of 1223 samples were analyzed. There was a significant difference between the reference method glucose level (135 [Q1-Q3: 97 - 179] mg/dL) and monitor-measured glucose level (188.33 [Q1-Q3: 167.33-209.33] mg/dL) (P < 0.0001). A total of 18.5% of readings were following ISO 15197:2013 criteria and 67.25% of coordinates were within zone A and zone B of the consensus error grid. In the surveillance error grid analysis, about 29.4% of values were in the no-risk zone, 51.8% in slight risk, 18.6% in moderate risk, and 0.2% were in the severe risk zone.
The accuracy of the InCheck device for the estimation of blood glucose by PPG signal is not following the recommended guidelines. Hence, further research is necessary for programming or redesigning the hardware and software for a better result from this optical sensor-based non-invasive home glucose monitor.
糖尿病患者在家中使用需要一滴血的血糖仪或植入体内小针的连续血糖监测设备来监测血糖。然而，这两种方法都会给患者带来不适，可能会阻碍他们定期进行血糖检测。光电容积脉搏波描记法（PPG）传感技术是一种非侵入性血糖测量方法，PPG传感器可用于预测低血糖发作。InChcek是一款基于PPG的非侵入性血糖监测仪。然而，其准确性尚未得到验证。因此，本研究旨在评估用于估计血糖的非侵入性血糖监测仪InCheck的准确性。
在一家三级护理医院，前来进行血糖估计的患者先使用InCheck设备进行非侵入性血糖检测，然后通过实验室方法（葡萄糖氧化酶 - 过氧化物酶法）检测。比较这两个读数。我们使用国际标准化组织（ISO）15197:2013标准（如果参考血糖<100 mg/dL，95%的值应在参考读数的±（15 mg/dL）范围内；如果参考血糖≥100 mg/dL，95%的值应在参考读数的±15%范围内，并且99%的值应在共识误差网格的A区和B区内）以及监测误差网格来分析准确性。
共分析了1223个样本。参考方法测得的血糖水平（135 [四分位距：97 - 179] mg/dL）与监测仪测得的血糖水平（188.33 [四分位距：167.33 - 209.33] mg/dL）之间存在显著差异（P < 0.0001）。共有18.5%的读数符合ISO 15197:2013标准，67.25%的坐标位于共识误差网格的A区和B区内。在监测误差网格分析中，约29.4%的值处于无风险区，51.8%处于轻微风险区，18.6%处于中度风险区，0.2%处于严重风险区。
InCheck设备通过PPG信号估计血糖的准确性未遵循推荐指南。因此，有必要进一步研究对该基于光学传感器的非侵入性家用血糖监测仪的硬件和软件进行编程或重新设计，以获得更好的结果。
