Validating CGM for GDM

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06858787
Status
Recruiting
Apply to this trial

Conditions

  • Gestational Diabetes Mellitus (GDM)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Continuous glucose monitor — DEVICE
    Device is a remote sensor applied to the upper extremity that continuously samples glucose of interstitial fluid and uploading results to a mobile application.

Study Details

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.

Key Dates

Start date
Oct 2, 2025
Status verified
Jan 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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

Primary Outcome Measure

Blood glucose from CGM [ Time Frame: 10 days from sensor application to completion of testing ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Nicola Tavella, MPH
[email protected]
2122413888
Angela Bianco, MD (PRINCIPAL_INVESTIGATOR)
Mount Sinai South NassauOceansideNew York11572
Dina El Kady, MD

Find similar trials in New York, NY

By research site
Icahn School of Medicine at Mount Sinai· New York, NYMount Sinai South Nassau· Oceanside, NY

Related Studies