{"title":"[Clinical Validation of a Prototype Smart Non-Invasive Pregnancy Glucose Monitor].","authors":"Heqing Lu, Lirui Cheng, Qiaoling Du, Xiaofeng Zhang, Zhenzhen Sun, Zhigang Zhu","doi":"10.12455/j.issn.1671-7104.240106","DOIUrl":null,"url":null,"abstract":"<p><p>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 <i>via</i> traditional blood glucose measurement methods, whereas no significant difference ( <i>P</i><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.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"中国医疗器械杂志","FirstCategoryId":"1087","ListUrlMain":"https://doi.org/10.12455/j.issn.1671-7104.240106","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0
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.