Validating CGM for GDM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous glucose monitor.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes Mellitus (GDM). Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Validity of a Continuous Glucose Monitor in Diagnosing Gestational Diabetes: A Pilot Study
Overview
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.
Interventions
- Device Continuous 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.
Primary outcome measures
- Blood glucose from CGM [Time frame: 10 days from sensor application to completion of testing]
- Glucose Tolerance Test (GTT) values [Time frame: 1 hour and 3 hours]
- Postpartum blood glucose [Time frame: 4 hours after childbirth]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 2 centers
- Icahn School of Medicine at Mount Sinai — New York
- Mount Sinai South Nassau — Oceanside
Identifiers
NCT: NCT06858787 · STUDY-25-00172