Validating CGM for GDM
The Validity of a Continuous Glucose Monitor in Diagnosing Gestational Diabetes: A Pilot Study
Icahn School of Medicine at Mount Sinai
150 participants
Oct 2, 2025
INTERVENTIONAL
Conditions
Summary
This is a prospective pilot study to assess the validity of using a continuous glucose monitor (CGM) in diagnosing gestational diabetes mellitus (GDM). Pregnant individuals between the ages of 18-50 years old receiving prenatal care at Mount Sinai Hospital (e..g, E-Level clinic and Faculty Practice Associates) will be enrolled. Potential participants will be approached during their prenatal care appointments. Participants will complete an informed consent form for the study during their standard-of-care prenatal appointments at our institution.
Eligibility
Inclusion Criteria3
- Ages 18-50
- Singleton pregnancy between 24-32 weeks gestational age
- Prenatal care and delivery at Mount Sinai Hospital
Exclusion Criteria6
- Multiple fetal gestation
- Preexisting diabetes
- Concurrent use of steroids
- Anomalous fetus
- Insufficient prenatal care (identified as missing half the recommended visits or establishing care after 20 weeks gestation)
- Unable to tolerate oral glucose test
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Interventions
Device is a remote sensor applied to the upper extremity that continuously samples glucose of interstitial fluid and uploading results to a mobile application.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06858787