CGM for the Early Detection and Management of Hyperglycemia in Pregnancy
Start Date
5/27/2025
Completion Date
11/27/2027
Summary
The goal of this clinical trial is to use continuous glucose monitoring (CGM) to quickly detect and manage high blood sugar in pregnant women, early in pregnancy. The main questions it aims to answer are: (1) any problems for the baby, such as being too large for their age, shoulder injuries (like broken bones), high bilirubin levels needing light treatment, low blood sugar, or needing to stay in the NICU; (2) any high blood pressure issues for the mother during pregnancy.
Detailed Description
Data from continuous glucose monitoring (CGM) in the Glucose Lowering group tracked over time, will be compared to data from blinded sensors in the Usual Care group approximately every 4 weeks. * Pregnant women who do not have diabetes and have a single, uncomplicated pregnancy will be enrolled by 14 weeks and 6 days. They will start by wearing a hidden CGM sensor to check for high blood sugar. * The blinded CGM sensor data will be evaluated to determine if the following criterion is met: 5% to \<25% of values \>140 mg/dL • An initial assessment will be made after 5 days and for those not meeting the criterion, again after 10 days * Participants meeting the CGM hyperglycemia criteria and the other study eligibility criteria will proceed to randomization, which must be performed by 16 weeks 6 days of gestation. * Participants who do not meet the CGM hyperglycemia criteria will form an observational cohort, provided that HbA1c is \<6.5% (48 mmol/mol)
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Diabetes Treatment
Usual Care Group
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35173
United States
University of Miami
Miami, Florida 33016
United States
Emory University
Decatur, Georgia 30033
United States
IDC at Park Nicollet
Saint Louis Park, Minnesota 55416
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
Oregon Health & Science University
Portland, Oregon 97239
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Leeds Teaching Hospitals NHS Trust
Leeds, Leeds
United Kingdom
Norfolk and Norwich University Hospitals NHS
Norwich, Norwich
United Kingdom