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

作　　者：路鹤晴[1] 程立瑞 杜巧玲[1] 张晓峰[1] 孙珍珍 朱志刚 LU Heqing;CHENG Lirui;DU Qiaoling;ZHANG Xiaofeng;SUN Zhenzhen;ZHU Zhigang(Shanghai First Maternity and Infant Hospital,School of Medicine,Tongji University,Shanghai,201204;University of Shanghai for Science and Technology,Shanghai,200093)

机构地区：[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

出　　处：《中国医疗器械杂志》2024年第5期539-543,共5页Chinese Journal of Medical Instrumentation

基　　金：上海市科技创新行动计划项目(21S31902100);国家卫健委医管所2022医学工程研究项目(2022MEB108);2022上海市浦东新区妇产科医联体项目(2023LYPYB05);微创雍恩医工交叉创新横向基金项目(MP2022Q4C006、1503)。

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。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 

分 类 号：R197.39[医药卫生—卫生事业管理] TH776[医药卫生—公共卫生与预防医学]