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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
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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.
作者 路鹤晴 程立瑞 杜巧玲 张晓峰 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)
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)。
关键词 无创 血糖监测 妊娠期 糖尿病 光电容积技术 non-invasive blood glucose monitoring gestation period diabetes photoplethysmography
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