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Recruiting NCT06858787

NCT06858787 Validating CGM for GDM

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Clinical Trial Summary
NCT ID NCT06858787
Status Recruiting
Phase
Sponsor Icahn School of Medicine at Mount Sinai
Condition Gestational Diabetes Mellitus (GDM)
Study Type INTERVENTIONAL
Enrollment 150 participants
Start Date 2025-10-02
Primary Completion 2028-04

Eligibility & Interventions

Sex Female only
Min Age 18 Years
Max Age 50 Years
Study Type INTERVENTIONAL
Interventions
Continuous glucose monitor

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 150 participants in total. It began in 2025-10-02 with a primary completion date of 2028-04.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Nicola F Tavella, MPH

✉ nicola.tavella@mssm.edu

📞 212-241-3888

Principal Investigator

Angela Bianco, MD

PRINCIPAL INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Frequently Asked Questions

Who can join the NCT06858787 clinical trial?

This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Gestational Diabetes Mellitus (GDM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06858787 currently recruiting?

Yes, NCT06858787 is actively recruiting participants. Contact the research team at nicola.tavella@mssm.edu for enrollment information.

Where is the NCT06858787 trial being conducted?

This trial is being conducted at New York, United States, Oceanside, United States.

Who is sponsoring the NCT06858787 clinical trial?

NCT06858787 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Angela Bianco, MD at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 150 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: July 2026  ·  Data Methodology