Valent Amy M, Rickert Michaela, Pagan Christian Huerta, Ward Lucy, Dunn Emily, Rincon Monica
School of Medicine, Department of Obstetrics & Gynecology, Division Maternal-Fetal Medicine, Oregon Health & Science University, Portland, OR.
College of Nursing, University of Colorado, Denver, CO.
Diabetes Care. 2025 Sep 1;48(9):1581-1588. doi: 10.2337/dc25-0115.
To compare the efficacy of real-time continuous glucose monitoring (CGM; intervention) with capillary blood glucose (CBG) monitoring (control) alone to achieve greater percent glucose time in range (%TIR) among pregnant individuals diagnosed gestational diabetes mellitus (GDM).
This was an open-label, single-center, randomized controlled trial of pregnant individuals with GDM and ≥20 weeks' gestation. Subjects were randomly assigned (2:1) to use real-time CGM plus adjunctive CBG versus CBG alone for glucose monitoring. The intervention group was instructed on the continuous use of the Dexcom G6 CGM system from enrollment to admission for delivery. The control group used CBG monitoring four times per day underwent blinded CGM approximately every 20 days throughout the study period. The primary outcome was the CGM %TIR defined as 60-140 mg/dL (3.3-7.8 mmol/L) from study enrollment until hospital admission for delivery.
A total of 111 participants were enrolled between February 2021 and June 2023 (n = 74 in intervention group; n = 37 in control group) with no statistical differences in demographic characteristics between the groups. The CGM group had significantly higher %TIR ±SD (93 ± 6 min vs. 88 ± 14 min at 60-140 mg/dL; P = 0.027). Among key secondary CGM metric outcomes, the intervention group had significantly higher daytime TIR with lower 24-h and daytime mean glucose and percent time >140 mg/dL compared with the control group.
We demonstrated a significantly higher %TIR using real-time CGM compared with CBG glucose monitoring among pregnant people with GDM. Studies are needed to determine if achieving lower CGM glucose levels can improve perinatal and neonatal outcomes.
比较实时动态血糖监测（CGM；干预措施）与单纯指尖血糖（CBG）监测（对照）在确诊为妊娠期糖尿病（GDM）的孕妇中实现更高血糖达标时间百分比（%TIR）的疗效。
这是一项针对孕周≥20周的GDM孕妇的开放标签、单中心随机对照试验。受试者被随机分配（2:1）使用实时CGM加辅助CBG与单纯CBG进行血糖监测。干预组从入组到分娩入院期间接受持续使用德康G6 CGM系统的指导。对照组每天进行4次CBG监测，在整个研究期间大约每20天接受一次盲法CGM监测。主要结局是CGM %TIR，定义为从研究入组到分娩入院期间血糖水平在60 - 140 mg/dL（3.3 - 7.8 mmol/L）的时间百分比。
2021年2月至2023年6月期间共招募了111名参与者（干预组n = 74；对照组n = 37），两组间人口统计学特征无统计学差异。CGM组的%TIR±标准差显著更高（血糖水平在60 - 140 mg/dL时为93±6分钟 vs. 88±14分钟；P = 0.027）。在关键的次要CGM指标结局中，与对照组相比，干预组白天的TIR显著更高，24小时和白天的平均血糖更低，血糖水平>140 mg/dL的时间百分比更低。
我们证明，与GDM孕妇单纯进行CBG血糖监测相比，使用实时CGM可显著提高%TIR。需要开展研究以确定实现更低的CGM血糖水平是否能改善围产期和新生儿结局。
