Pilot Study to Test a Continuous Glucose Monitor for Diagnosing Gestational Diabetes in Pregnant Women

What this Trial Is About

Researchers are conducting a pilot study to evaluate the accuracy of using a continuous glucose monitor CGM to diagnose gestational diabetes mellitus GDM in pregnant women. This study focuses on individuals aged 18 to 50 years who are receiving prenatal care at Mount Sinai Hospital. The research aims to determine whether CGM can effectively capture blood glucose levels compared to standard testing methods during pregnancy. Participants will have a CGM device applied to their upper arm for 10 days. This device continuously measures glucose levels in the interstitial fluid and uploads the data to a mobile app. The study involves a single group of pregnant women who will use the CGM during their prenatal care period, with no placebo or comparison group. The device use coincides with standard prenatal visits and glucose tolerance testing. During the study, participants will undergo glucose tolerance tests at 1 and 3 hours and have postpartum blood glucose measured 4 hours after childbirth. Researchers will collect and compare glucose data from the CGM over the 10-day monitoring period to these traditional measures. Participants complete informed consent during routine prenatal appointments, and the study follows them from sensor application through delivery and postpartum assessments, lasting until April 2028.

Validating CGM for GDM