Recruiting

Continuous Glucose Monitor

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06858787

Conditions

Gestational Diabetes Mellitus (GDM)

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Continuous glucose monitor

Study Details

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.

Conditions

Gestational Diabetes Mellitus (GDM)

Study ID

NCT06858787

Start date

Oct 2, 2025

Status verified date

Aug, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

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

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Individuals receiving prenatal care at Mount Sinai Hospital

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

Interventions

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.

Primary outcome measure

  • Blood glucose from CGM [ Time Frame: 10 days from sensor application to completion of testing ]
  • Glucose Tolerance Test (GTT) values [ Time Frame: 1 hour and 3 hours ]
  • Postpartum blood glucose [ Time Frame: 4 hours after childbirth ]

Central Contacts and Locations

Central contacts

Nicola F Tavella, MPH

212-241-3888nicola.tavella@mssm.edu

Victoria Ly, MD

212-241-5681victoria.ly@mssm.edu

Locations

Mount Sinai West

Recruiting

New York, New York, United States, 10019

Contacts

Shelly Thai, MD

917-755-3033shelly.thai2@mountsinai.org

Nicola F Tavella, MPH, CPH

212-241-3888nicola.tavella@mssm.edu

Principal Investigator:

Lois Brustman, MD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Victoria Ly, MD

212-241-5681victoria.ly@mssm.edu

Nicola Tavella, MPH

212-241-3888nicola.tavella@mssm.edu

Principal Investigator:

Angela Bianco, MD

Mount Sinai South Nassau

Recruiting

Oceanside, New York, United States, 11572

Principal Investigator:

Dina El Kady, MD

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-08-13.