NCT06858787

Validating CGM for GDM

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gestational Diabetes Mellitus (GDM)

Interventions

Type	Name	Description
DEVICE	Continuous 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.

Timeline

• Start date: 2025-10-02
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2025-03-05
• Last updated: 2026-01-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study