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Validating CGM for GDM

NCT06858787 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-01-15

No results posted yet for this 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.

Conditions

  • Gestational Diabetes Mellitus (GDM)

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Angela Bianco, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-02
Primary Completion
2028-04-30
Completion
2028-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06858787 on ClinicalTrials.gov