{"title":"[智能无创妊娠血糖监测仪原型的临床验证]。","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":"48 5","pages":"539-543"},"PeriodicalIF":0.0000,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"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\":\"48 5\",\"pages\":\"539-543\"},\"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}","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}
[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.
期刊介绍:
Chinese Journal of Medical Instrumentation mainly reports on the development, progress, research and development, production, clinical application, management, and maintenance of medical devices and biomedical engineering. Its aim is to promote the exchange of information on medical devices and biomedical engineering in China and turn the journal into a high-quality academic journal that leads academic directions and advocates academic debates.