๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-11

Validating CGM for GDM (NCT06858787)

The Validity of a Continuous Glucose Monitor in Diagnosing Gestational Diabetes: A Pilot Study

๐ŸŸข Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Icahn School of Medicine at Mount Sinai

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Mount Sinai West โ€” New York, New York

Age range: 18 Years to 50 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (3 Sites)

  • Mount Sinai West โ€” New York, New York
  • Icahn School of Medicine at Mount Sinai โ€” New York, New York
  • Mount Sinai South Nassau โ€” Oceanside, New York

๐Ÿ“ž Contact the Study Coordinator

Phone: (212) 241-3888

Email: nicola.tavella@mssm.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—