RecruitingNot ApplicableNCT06858787

Validating CGM for GDM

The Validity of a Continuous Glucose Monitor in Diagnosing Gestational Diabetes: A Pilot Study


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

150 participants

Start Date

Oct 2, 2025

Study Type

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

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

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

DEVICEContinuous glucose monitor

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)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Mount Sinai South Nassau

Oceanside, New York, United States

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NCT06858787


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