Study of Continuous Glucose Monitoring Compared to Oral Glucose Tolerance Test for Gestational Diabetes in Pregnant Women

What this Trial Is About

Researchers are evaluating the use of continuous glucose monitoring CGM to improve the diagnosis of gestational diabetes mellitus GDM in pregnant women of Chinese or Indian ethnicity. This study, called Integrated Continuous glucose monitoring glycemic cHAracterization during Pregnancy in comparison with oral glucose tolerance test I-CHAP, aims to compare CGM data with the standard oral glucose tolerance test OGTT and explore how CGM profiles relate to maternal and fetal outcomes. The study also seeks to assess how acceptable CGM is as a diagnostic tool compared to OGTT. Participants will wear a CGM sensor on the back of their upper arm for up to 10 days, including during their scheduled OGTT between 20 and 35 weeks of pregnancy. The CGM records glucose levels every 5 minutes from the interstitial fluid, capturing detailed glycemic data alongside the standard 3-point OGTT blood glucose measurements. Researchers will collect data on pregnancy and birth outcomes and participants will complete questionnaires about their experience and background. During the study, participants will be educated on CGM use and asked to record the exact time of their OGTT. Data collection includes glucose measurements from both CGM and OGTT, maternal and neonatal outcomes such as pre-eclampsia, hypertension, birth weight, and neonatal hypoglycemia. The study lasts for the duration of CGM wear and follows participants through to delivery, with outcome assessments at the end of pregnancy. Safety and acceptability of CGM as a diagnostic alternative to OGTT will also be evaluated.

Continuous Glucose Monitoring Glycemic cHAracterization During Pregnancy