Validating CGM for GDM

Not Applicable

Not yet recruiting

• Conditions: Gestational Diabetes Mellitus (GDM)

• Registration Number: NCT06858787
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-27
• Study First Submitted QC: 2025-02-27
• Last Update Submitted: 2025-02-27
• Study First Posted: 2025-03-05
• Last Update Posted: 2025-03-05
• Study Start: 2025-05
• Primary Completion: 2028-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Blood glucose from CGM	10 days from sensor application to completion of testing	Blood glucose aggregate values from Dexcom G7 continuous glucose monitor (CGM)
Glucose Tolerance Test (GTT) values	1 hour and 3 hours	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.
Postpartum blood glucose	4 hours after childbirth	A blood sugar test measures the amount of a sugar called glucose in a sample of blood.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States