Continuous glucose monitoring to diagnose gestational diabetes
Official title: The Validity of a Continuous Glucose Monitor in Diagnosing Gestational Diabetes: A Pilot Study
Run by Icahn School of Medicine at Mount Sinai · NCT06858787 · Data updated 2026-11-12
A continuous glucose monitor will be tried to see if it can diagnose gestational diabetes in pregnant people between 24 and 32 weeks who receive prenatal care at Mount Sinai.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 150 (estimated) |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 3 sites (New York, New York and 2 other locations) |
| Status | Recruiting |
| Started | October 2, 2025 |
| Main results expected | April 2028 |
| Study ends | April 2028 |
| Registry record updated | August 13, 2026 |
| Trial ID | NCT06858787 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant people aged 18–50 with a singleton pregnancy at 24–32 weeks who receive prenatal care and plan delivery at Mount Sinai and who can tolerate the oral glucose test are ideal candidates.
✕Probably not a fit
People with preexisting diabetes, multiple gestation, current steroid use, major fetal anomalies, insufficient prenatal care, or inability to tolerate the oral glucose test are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective pilot enrolling pregnant people aged 18–50 with a singleton pregnancy at 24–32 weeks who receive prenatal care and plan delivery at Mount Sinai Hospital or Mount Sinai South Nassau. Participants will be approached during routine prenatal visits, provide informed consent, and wear a continuous glucose monitor while undergoing standard-of-care glucose testing. CGM glucose patterns will be compared with oral glucose tolerance test results and clinical diagnoses to determine whether CGM can identify gestational diabetes. The goal is to learn if CGM could serve as a reliable, less burdensome diagnostic option.
Why it matters
Potential benefit: If successful, CGM could provide continuous, less invasive glucose data that may simplify or reduce the need for the oral glucose tolerance test and improve the convenience and timing of diagnosis.
How similar studies have gone: Prior research has shown CGM can reveal glucose patterns and aid management in pregnancy, but using CGM alone as a diagnostic replacement for the oral glucose tolerance test is relatively novel and still being tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Mount Sinai West
New York, New York, United States Recruiting -
Icahn School of Medicine at Mount Sinai
New York, New York, United States Recruiting -
Mount Sinai South Nassau
Oceanside, New York, United States Recruiting
Study contacts
- Principal investigator: Angela Bianco, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Nicola F Tavella, MPH
- Email: nicola.tavella@mssm.edu
- Phone: 212-241-3888
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.