Study of Continuous Glucose Monitor Use Versus Fingerstick Monitoring in Pregnant Women With Type 2 Diabetes to Improve Pregnancy Outcomes

What this Trial Is About

Researchers are evaluating the use of continuous glucose monitors CGM compared to the standard fingerstick glucose monitoring in pregnant women with type 2 diabetes mellitus T2DM. This randomized controlled trial aims to assess the impact of CGM use on outcomes such as the frequency of large for gestational age infants, maternal blood sugar control, patient satisfaction, and other adverse perinatal results. The study addresses the lack of data on CGM use in pregnant women with T2DM, despite its recommended use in other diabetes types and potential benefits shown in preliminary studies for type 1 diabetes. The study involves 180 pregnant women with T2DM who are randomly assigned to one of two groups. One group uses the continuous glucose monitor device throughout pregnancy until delivery, applying the device in a clinical setting and learning to download glucose data to their smartphones or device reader. The other group follows the standard care practice of multiple daily fingerstick glucose checks, measuring blood sugar fasting in the morning and two hours after meals. Both approaches are compared to evaluate differences in maternal and infant outcomes. Participants will be involved throughout their pregnancy, using either the CGM device or fingerstick monitoring as assigned. Researchers will assess outcomes including infant size at birth, maternal blood sugar control during the third trimester, delivery method, pregnancy complications like hypertension or preterm birth, and neonatal health indicators such as respiratory distress and hypoglycemia. Patient satisfaction with glucose monitoring is also measured after delivery. The study is sponsored by the University of Massachusetts and is expected to complete by mid-2027.

Continuous Glucose Monitor Use in Pregnancy