CClinicalTrials.gg
RecruitingNCT06858787VALIDUpdated Aug 13, 2026

Validating CGM for GDM

An interventional study of Continuous glucose monitor in Gestational Diabetes Mellitus (GDM), sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 3 sites in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Female
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Study 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.

02

Conditions studied

  • Gestational Diabetes Mellitus (GDM)

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03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's planned enrollment of 150 is above the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.

Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Ages 18-50
  • Singleton pregnancy between 24-32 weeks gestational age
  • Prenatal care and delivery at Mount Sinai Hospital

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    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

    Device: Continuous glucose monitor

Interventions

  • DeviceContinuous 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.

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What researchers measure

Primary outcomes

  1. Blood glucose from CGM

    Blood glucose aggregate values from Dexcom G7 continuous glucose monitor (CGM)

    Time frame: 10 days from sensor application to completion of testing

  2. Glucose Tolerance Test (GTT) values

    1-hour GTT values and 3-hour GTT values The glucose tolerance test is a lab test to check how the body moves sugar from the blood into tissues like muscle and fat. The test is used as standard of care to diagnose gestational diabetes.

    Time frame: 1 hour and 3 hours

  3. Postpartum blood glucose

    A blood sugar test measures the amount of a sugar called glucose in a sample of blood.

    Time frame: 4 hours after childbirth

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Study locations

3 of 3 sites recruiting
  • Mount Sinai West
    New York, New York 10019, United States
    Recruiting
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
    Recruiting
  • Mount Sinai South Nassau
    Oceanside, New York 11572, United States
    • Dina El Kady, MD · Contact
    • Dina El Kady, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06858787
Lead sponsor
Icahn School of Medicine at Mount Sinai
Responsible party
Angela Bianco (Professor, Icahn School of Medicine at Mount Sinai) — Principal investigator
First posted
Mar 5, 2025
Start date
Oct 2, 2025
Primary completion
Apr 2028 (estimated)
Completion
Apr 2028 (estimated)
Last update
Aug 13, 2026

Study contacts

Nicola F Tavella, MPH
Contact
nicola.tavella@mssm.edu
212-241-3888
Victoria Ly, MD
Contact
victoria.ly@mssm.edu
212-241-5681
Angela Bianco, MD
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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