Leeds Institute of Cardiovascular and Metabolic Medicine, School of Medicine, LIGHT Laboratories, University of Leeds, Clarendon Way, Leeds, LS2 9JT, UK.
Norwich Medical School, University of East Anglia, Norwich, UK.
BMC Pregnancy Childbirth. 2023 Aug 3;23(1):563. doi: 10.1186/s12884-023-05824-x.
Continuous glucose monitoring (CGM) provides the most objective method of assessing glucose in daily life. Although there have been small, short-term physiologic studies of glucose metabolism in 'healthy' pregnant women a comprehensive, longitudinal description of changes in glucose over the course of pregnancy and how glucose dysregulation earlier in pregnancy relates to traditional third trimester screening for gestational diabetes, fetal growth and pregnancy outcomes is lacking. This study aims to characterise longitudinal changes in glycemia across gestation using CGM, in order to understand the evolution of dysglycemia and its relationship to fetal growth.
METHOD/DESIGN: A multi-centre, prospective, observational, cohort study of 500 healthy pregnant women, recruited in the first trimester of pregnancy. Masked CGM will be performed for a 14-day period on five occasions across pregnancy at ~ 10-12, 18-20, 26-28, 34-36 weeks gestation and postnatally. Routinely collected anthropometric and sociodemographic information will be recorded at each visit including: weight, height, blood pressure, current medication. Age, parity, ethnicity, smoking will be recorded. Blood samples will be taken at each visit for HbA1c and a sample stored. Details on fetal growth from ultrasound scans and the OGTT results will be recorded. Maternal and neonatal outcomes will be collected. CGM glucose profiling is the exposure of interest, and will be performed using standard summary statistics, functional data analysis and glucotyping. The primary maternal outcome is clinical diagnosis of GDM. The primary neonatal outcome is large for gestational age (LGA) (> 90th centile defined by customised birthweight centile). The relationship of glucose to key secondary maternal and neonatal outcomes will be explored.
This study will ascertain the relationship of maternal dysglycemia to fetal growth and outcomes. It will explore whether CGM glucose profiling can detect GDM before the OGTT; or indeed whether CGM glucose profiling may be more useful than the OGTT at detecting LGA and other perinatal outcomes.
ISRCTN 15,706,303 https://www.isrctn.com/ISRCTN15706303 Registration date: 13th March 2023.
连续血糖监测（CGM）提供了评估日常生活中血糖的最客观方法。尽管已经有一些关于“健康”孕妇血糖代谢的小型短期生理学研究，但对于整个孕期内血糖的变化以及孕期早期血糖失调与传统的妊娠糖尿病、胎儿生长和妊娠结局的第三孕期筛查之间的关系，缺乏全面的纵向描述。本研究旨在使用 CGM 描述妊娠期间血糖的纵向变化，以了解血糖失调的演变及其与胎儿生长的关系。
方法/设计：一项多中心、前瞻性、观察性、队列研究，纳入了 500 名健康孕妇，在妊娠早期招募。在妊娠期间，将在五个时间点（约 10-12、18-20、26-28、34-36 周妊娠和产后）使用 CGM 进行为期 14 天的五次监测。每次就诊时还将记录常规收集的人体测量学和社会人口统计学信息，包括：体重、身高、血压、当前用药。年龄、产次、种族、吸烟情况将被记录。每次就诊时都会采集血样进行 HbA1c 检测，并储存一份样本。将记录超声扫描和 OGTT 结果的胎儿生长详细信息。将收集母婴结局。CGM 血糖谱是感兴趣的暴露因素，将使用标准汇总统计、功能数据分析和血糖分型进行分析。主要的产妇结局是临床诊断的 GDM。主要的新生儿结局是大于胎龄儿（LGA）（通过定制的体重百分位数定义为>第 90 百分位数）。将探讨血糖与关键次要产妇和新生儿结局的关系。
本研究将确定母体血糖失调与胎儿生长和结局的关系。它将探讨 CGM 血糖谱是否能在 OGTT 之前检测到 GDM；或者 CGM 血糖谱是否比 OGTT 更能检测到 LGA 和其他围产期结局。
ISRCTN 15,706,303 https://www.isrctn.com/ISRCTN15706303 注册日期：2023 年 3 月 13 日。
