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Recruiting NCT06858787

NCT06858787 Validating CGM for GDM

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Clinical Trial Summary
NCT ID NCT06858787
Status Recruiting
Phase
Sponsor Icahn School of Medicine at Mount Sinai
Condition Gestational Diabetes Mellitus (GDM)
Study Type INTERVENTIONAL
Enrollment 150 participants
Start Date 2025-10-02
Primary Completion 2028-04

Trial Parameters

Condition Gestational Diabetes Mellitus (GDM)
Sponsor Icahn School of Medicine at Mount Sinai
Study Type INTERVENTIONAL
Phase N/A
Enrollment 150
Sex FEMALE
Min Age 18 Years
Max Age 50 Years
Start Date 2025-10-02
Completion 2028-04
Interventions
Continuous glucose monitor

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Brief 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 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

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