中国医疗器械杂志2024,Vol.48Issue(5) :539-543.DOI:10.12455/j.issn.1671-7104.240106

智能无创妊娠期血糖监测仪样机的临床验证

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

路鹤晴 程立瑞 杜巧玲 张晓峰 孙珍珍 朱志刚
中国医疗器械杂志2024,Vol.48Issue(5) :539-543.DOI:10.12455/j.issn.1671-7104.240106

智能无创妊娠期血糖监测仪样机的临床验证

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

路鹤晴 1程立瑞 2杜巧玲 1张晓峰 1孙珍珍 1朱志刚2
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作者信息

  • 1. 同济大学附属妇产科医院,上海市,201204
  • 2. 上海理工大学,上海市,200093
  • 折叠

摘要

该研究旨在通过临床验证,评估一款智能无创妊娠期血糖监测仪样机的有效性.该监测仪基于近红外光谱法,利用AI大数据分析光电容积脉搏波数据,实现对妊娠期妇女血糖的无创监测.研究团队开发了一种利用感测芯片的监测仪,有效克服了无创血糖监测中的信号弱和个体差异问题.通过智能无创妊娠期血糖监测仪配套手机APP(application)上直观显示检测结果,提升了用户体验.临床验证显示,20~30岁孕妇的无创监测数据与传统血糖测量方法存在显著差异(P<0.05),而31~42岁孕妇则无显著差异.研究指出,该监测仪需进一步校准和扩大样本量,以提高与有创血糖监测结果的一致性.

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.

关键词

无创/血糖监测/妊娠期/糖尿病/光电容积技术

Key words

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

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出版年

2024
中国医疗器械杂志
上海市医疗器械检测所

中国医疗器械杂志

CSTPCD
影响因子:0.503
ISSN:1671-7104
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