LU Heqing, CHENG Lirui, DU Qiaoling, ZHANG Xiaofeng, SUN Zhenzhen, ZHU Zhigang. Clinical Validation of a Prototype Smart Non-Invasive Pregnancy Glucose Monitor[J]. Chinese Journal of Medical Instrumentation, 2024, 48(5): 539-543. DOI: 10.12455/j.issn.1671-7104.240106
      Citation: LU Heqing, CHENG Lirui, DU Qiaoling, ZHANG Xiaofeng, SUN Zhenzhen, ZHU Zhigang. Clinical Validation of a Prototype Smart Non-Invasive Pregnancy Glucose Monitor[J]. Chinese Journal of Medical Instrumentation, 2024, 48(5): 539-543. DOI: 10.12455/j.issn.1671-7104.240106

      Clinical Validation of a Prototype Smart Non-Invasive Pregnancy Glucose Monitor

      • The aim of this study is to evaluate the effectiveness of a smart non-invasive blood glucose monitor prototype during pregnancy through clinical validation. The monitor utilizes near-infrared spectroscopy combined with AI big data analysis of photoelectric volumetric pulse wave data to achieve non-invasive monitoring of blood glucose in women during pregnancy. The research team developed a monitor that employs a sensing chip, effectively overcoming the problems of weak signals and individual differences in non-invasive blood glucose monitoring. The user experience is enhanced by visualizing the test results on the accompanying cell phone APP (application) of the smart non-invasive pregnancy blood glucose monitor. Clinical validation revealed that the non-invasive monitoring data for pregnant women aged 20~30 years significantly differed from those obtained via traditional blood glucose measurement methods, whereas no significant difference (P<0.05) was observed for pregnant women aged 31~42 years. The study concluded that further calibration of the monitor and an expansion of the sample size are necessary to enhance consistency with invasive glucose monitoring results.
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