Validating CGM for GDM

NCT ID: NCT06858787

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-02

Study Completion Date

2028-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gestational Diabetes Mellitus (GDM)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Continuous glucose monitor

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Angela Bianco

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Angela Bianco, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status RECRUITING

Mount Sinai South Nassau

Oceanside, New York, United States

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nicola F Tavella, MPH

Role: CONTACT

212-241-3888

Victoria Ly, MD

Role: CONTACT

212-241-5681

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nicola Tavella, MPH

Role: primary

2122413888

Dina El Kady, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY-25-00172

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.