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

Validating CGM for GDM (NCT06858787)

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: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (7 items).

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

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

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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

๐Ÿ” Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

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’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›๏ธ View Official NIH Record โ†—