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

Abstract

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.

Keywords

• non-invasive
• blood glucose monitoring
• gestation period
• diabetes
• photoplethysmography