Validating CGM for GDM (VALID)

Mount Sinai Health System

Status: Enrolling

Conditions: Gestational Diabetes Mellitus (GDM)

Treatments: Device: Continuous glucose monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT06858787

STUDY-25-00172

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Individuals receiving prenatal care at Mount Sinai Hospital

Experimental group

Description:

Women receiving prenatal care at Mount Sinai Hospital to have 10-day application of continuous glucose monitor

Treatment:

Device: Continuous glucose monitor