Randomized Trial of Continuous Glucose Monitoring Versus Blood Glucose Testing for Women With Gestational Diabetes

What this Trial Is About

Researchers are evaluating continuous glucose monitoring CGM compared to self-monitoring of blood glucose SMBG in women diagnosed with gestational diabetes GDM, including both early and late diagnoses. This randomized controlled trial RCT aims to study pregnancy outcomes and glucose control in women with GDM. The study is conducted across 16 centers in Belgium and Australia, focusing on how glucose monitoring methods affect health during pregnancy and postpartum. Participants will be randomly assigned to either the intervention group using the Freestyle Libre 3 real-time CGM device continuously until delivery or the control group using standard SMBG with a glucometer, following routine care. Both groups will wear a blinded CGM sensor Freestyle Libre Pro IQ during specific pregnancy periods to collect glucose data. Women diagnosed with early GDM will have additional blinded CGM monitoring. After delivery, all participants undergo a 75g oral glucose tolerance test OGTT between 6 and 24 weeks postpartum and wear a blinded CGM device during this follow-up. During the study, participants will receive education on managing GDM with lifestyle changes and glucose monitoring. Researchers will collect data on glucose levels, time spent in target glucose ranges, hypoglycemia episodes, insulin use, pregnancy outcomes, and quality of life at various pregnancy stages and postpartum. The main outcome is a composite measure of pregnancy results at delivery. The trial includes monitoring physical activity, diet, symptoms of anxiety and depression, treatment satisfaction, and breastfeeding duration. Participation ends after the postpartum OGTT and follow-up assessments.

Continuous Glucose Monitoring for Women With Gestational Diabetes