Continuous Glucose Monitoring to Detect and Manage High Blood Sugar Early in Pregnancy for Women with Single Pregnancies

What this Trial Is About

Researchers are evaluating continuous glucose monitoring CGM to detect and manage high blood sugar early in pregnancy among women without diabetes carrying a single baby. The study aims to understand if early detection and management of hyperglycemia can reduce problems for the baby, such as being too large, shoulder injuries, high bilirubin needing treatment, low blood sugar, or NICU admission, and also to assess any high blood pressure issues for the mother during pregnancy. Pregnant women up to 14 weeks and 6 days of gestation will initially wear a blinded CGM sensor to screen for high blood sugar. Those who meet the studys hyperglycemia criteria will be randomized by 16 weeks and 6 days into either a Glucose Lowering group, wearing an unblinded CGM sensor continuously with nutrition and glucose management support, or a Usual Care group, receiving standard obstetrical care with periodic blinded CGM monitoring. Participants not meeting the criteria will form an observational group with ongoing monitoring. Participants will have regular visits about every 4 weeks, which may include telehealth, and weekly glucose data reviews for those in the treatment group. Researchers will assess outcomes including a combined measure of newborn complications and maternal high blood pressure up to 45 weeks of pregnancy. Safety and health will be monitored throughout, with data compared between groups to evaluate the impact of early CGM-based management.

CGM for the Early Detection and Management of Hyperglycemia in Pregnancy