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Validating CGM for GDM
The Validity of a Continuous Glucose Monitor in Diagnosing Gestational Diabetes: A Pilot Study
Who can join
Ages 18 to 50 · Women · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * Ages 18-50 * Singleton pregnancy between 24-32 weeks gestational age * Prenatal care and delivery at Mount Sinai Hospital Exclusion Criteria: * 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
About the study
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.
What is being tested
- Continuous glucose monitor (device)
Sponsor: Icahn School of Medicine at Mount Sinai · Participants: 150 · Started: Oct 2, 2025
Contact the study team
- Nicola F Tavella, MPH · Phone: 212-241-3888
- Victoria Ly, MD · Phone: 212-241-5681
Official record on ClinicalTrials.gov — NCT06858787
Locations in the U.S.
| New York | Icahn School of Medicine at Mount Sinai, New York Mount Sinai West, New York Mount Sinai South Nassau, Oceanside |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.