Validating CGM for GDM

Last updated: January 13, 2026
Sponsor: Icahn School of Medicine at Mount Sinai
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Continuous glucose monitor

Clinical Study ID

NCT06858787
STUDY-25-00172
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • Ages 18-50

  • Singleton pregnancy between 24-32 weeks gestational age

  • Prenatal care and delivery at Mount Sinai Hospital

Exclusion

Exclusion Criteria:

  • Multiple fetal gestation

  • Preexisting diabetes

  • Concurrent use of steroids

  • Anomalous fetus

  • Insufficient prenatal care (identified as missing half the recommended visits orestablishing care after 20 weeks gestation)

  • Unable to tolerate oral glucose test

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Continuous glucose monitor
Phase:
Study Start date:
October 02, 2025
Estimated Completion Date:
April 30, 2028

Connect with a study center

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York 5128581, New York 5128638 10029
    United States

    Active - Recruiting

  • Mount Sinai South Nassau

    Oceanside 5129603, New York 5128638 11572
    United States

    Site Not Available

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