CGM for Early Detection and Management of High Blood Sugar in Pregnancy

This study is looking at whether using a continuous glucose monitor (CGM) can help detect and manage high blood sugar early in pregnancy. You could be eligible if you are a woman aged 18 or older, are pregnant with one baby, and are up to 14 weeks and 6 days into your pregnancy. The study aims to see if using CGM helps prevent problems for the baby, such as being too large or having low blood sugar, and for the mother, like high blood pressure during pregnancy. Some participants will use an unblinded CGM and receive special nutrition information, while others will receive usual care and wear a blinded CGM periodically. The study plans to enroll 6000 participants.

Study design
This interventional study plans to enroll 6000 participants and compares two groups: one using an unblinded CGM with specific nutrition guidance, and another receiving usual care with a blinded CGM.
What's involved
You would wear a CGM sensor, either unblinded 24/7 or blinded for 10-14 days at routine visits. You would also receive either specific or general pregnancy nutrition information.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored from the start of the study until 45 weeks of pregnancy to track any neonatal complications or maternal hypertensive disorders.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06957028

CGM for the Early Detection and Management of Hyperglycemia in Pregnancy

Recruiting
NAAges 18+InterventionalScreening
Jaeb Center for Health Research
~6,000 participants
Updated 2025-12-23 on ClinicalTrials.gov
What's tested:Diabetes TreatmentUsual Care Group

At a glance

Recruiting sites
8 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite Endpoint of Neonatal Complications or Maternal Hypertensive Disorder of Pregnancy
Measured over Baseline to 45 weeks
Gestational Diabetes Mellitus in Pregnancy
10 sites across 10 states
Alabama1
Florida1
Georgia1
Minnesota1
New York1
Ohio1
Oregon1
Pennsylvania1
  • Celeste Durnwald, MD · STUDY_CHAIR · University of Pennsylvania
Judy Sibayan, MPH, CCRP, Epidemiologist
Email the study team

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  • Composite Endpoint of Neonatal Complications or Maternal Hypertensive Disorder of PregnancyBaseline to 45 weeks

    Composite endpoint of (1) neonatal complications of large for gestational age (LGA), shoulder dystocia (including humeral or clavicular fracture), elevated bilirubin requiring phototherapy, or neonatal intensive care unit (NICU) admission; or (2) maternal hypertensive disorder of pregnancy (HDP) .