CGM for the Early Detection and Management of Hyperglycemia in Pregnancy

Recruiting now · Not applicable

Conditions studied: Gestational Diabetes Mellitus in Pregnancy

In brief

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.

Key facts

Study ID

NCT06957028

Run by

Jaeb Center for Health Research

People needed

6000

Starts

2025-05-27

Expected to finish

2027-11-27

Last updated by the study team

2025-12-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Maternal age of 18 years and older
• Singleton pregnancy
• Gestational age up to 14w 6d of pregnancy, determined on ultrasound, for initiation of screening
• Although it is preferable that ultrasound results be available prior to enrollment, if ultrasound results are not available at the time of enrollment, participant can have CGM initiated but will be dropped if not eligible after results are available
• HbA1c <6.5% (48 mmol/mol) since onset of pregnancy
• If HbA1c result not available at time of enrollment, participant can have blinded screening CGM initiated, but results will be needed prior to randomization to verify eligibility.
• No prior history of gestational diabetes mellitus (GDM)
• Able to read English or Spanish

You may not qualify if…

• Signs of abnormal fetal or placental development (suspected fetal anomaly or placenta accreta spectrum, low PAPPA) at first routine prenatal visit/ultrasound
• Planned termination of pregnancy or any indications of miscarriage
• Prior gastric bypass surgery
• Pregravid diabetes (type 1 or type 2)
• Unwillingness/inability to wear CGM sensor
• Unwillingness to attend routine antenatal obstetric appointments
• Use of corticosteroids by a route that can produce hyperglycemia (e.g., oral, intravenous, intramuscular, intra-articular) during the 7 days prior to initiating CGM screening or during the CGM screening
• Topical and inhaled corticosteroids are acceptable
• Use of insulin during the pregnancy prior to enrollment
• Use of metformin within one week of the initiation of the blinded CGM sensor for screening or use of a GLP-1 or other weight-reduction medication that can affect glucose levels within 4 weeks of the initiation of the blinded CGM sensor for screening
• Deemed unable to participate for medical reasons identified by their physician
• Additional Criteria for RCT Eligibility
• Screening CGM meeting study criteria for hyperglycemia: 5% to <25% time >140 mg/dL
• Randomization by 16 week 6 days of pregnancy
• No participation in a separate intervention trial.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• University of Miami — Miami, Florida, United States (enrolling)
• Emory University — Decatur, Georgia, United States (enrolling)
• IDC at Park Nicollet — Saint Louis Park, Minnesota, United States (enrolling)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Oregon Health & Science University — Portland, Oregon, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Leeds Teaching Hospitals NHS Trust — Leeds, Leeds, United Kingdom
• Norfolk and Norwich University Hospitals NHS — Norwich, Norwich, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.