Study of Real-Time Continuous Glucose Monitoring Versus Traditional Monitoring in Pregnant Women with Type 2 Diabetes

What this Trial Is About

The prevalence of type 2 diabetes mellitus T2DM among women of childbearing age is rising, and poor blood sugar control during pregnancy increases risks for both mothers and infants. Researchers are evaluating the use of real-time continuous glucose monitoring CGM compared with standard self-monitoring of blood glucose SMBG in pregnant women with T2DM. This multicenter, open-label, randomized trial aims to assess the effectiveness and safety of these monitoring methods within a multidisciplinary care system. Participants are pregnant women with T2DM receiving intensive insulin therapy, randomly assigned to either a real-time CGM group or a conventional SMBG group. Women in the CGM group wear the device for more than half of their pregnancy alongside regular SMBG, while the control group uses only SMBG. Both groups wear a blinded glucose monitor for three days during early, mid, and late pregnancy to record time in the target glucose range TIR. Throughout the study, participants undergo regular glucose monitoring, insulin dose adjustments, and assessments including glycated hemoglobin, hypoglycemia events, pregnancy weight gain, and maternal and infant outcomes. The primary measure compares TIR between groups at 24-28 weeks and 34-38 weeks gestation. Secondary outcomes include various glucose variability metrics, insulin use, pregnancy complications, and newborn health indicators. The study lasts through pregnancy to six weeks postpartum.

Real Time Continuous Glucose Monitoring System in T2DM With Pregnacy