Validating CGM for GDM
VALID
The Validity of a Continuous Glucose Monitor in Diagnosing Gestational Diabetes: A Pilot Study
1 other identifier
interventional
150
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2025
CompletedFirst Posted
Study publicly available on registry
March 5, 2025
CompletedStudy Start
First participant enrolled
October 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
January 15, 2026
January 1, 2026
2.5 years
February 27, 2025
January 13, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Blood glucose from CGM
Blood glucose aggregate values from Dexcom G7 continuous glucose monitor (CGM)
10 days from sensor application to completion of testing
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.
1 hour and 3 hours
Postpartum blood glucose
A blood sugar test measures the amount of a sugar called glucose in a sample of blood.
4 hours after childbirth
Study Arms (1)
Individuals receiving prenatal care at Mount Sinai Hospital
EXPERIMENTALWomen receiving prenatal care at Mount Sinai Hospital to have 10-day application of continuous glucose monitor
Interventions
Device is a remote sensor applied to the upper extremity that continuously samples glucose of interstitial fluid and uploading results to a mobile application.
Eligibility Criteria
You may qualify if:
- Ages 18-50
- Singleton pregnancy between 24-32 weeks gestational age
- Prenatal care and delivery at Mount Sinai Hospital
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Mount Sinai South Nassau
Oceanside, New York, 11572, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angela Bianco, MD
Icahn School of Medicine at Mount Sinai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 27, 2025
First Posted
March 5, 2025
Study Start
October 2, 2025
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
January 15, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share