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NCT Number: NCT06858787

Validating CGM for GDM

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.

Recruiting

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Key information

Conditions

Gestational Diabetes Mellitus (GDM) Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Glucose Monitor

Device

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 outcomes

  1. Blood glucose from CGM

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

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

  2. Glucose Tolerance Test (GTT) values

    Time frame: 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.

  3. Postpartum blood glucose

    Time frame: 4 hours after childbirth

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

Study contacts

Contact information is provided by the study sponsor or research team.

Nicola F Tavella, MPH

CONTACT

[email protected]

212-241-3888

Victoria Ly, MD

CONTACT

[email protected]

212-241-5681

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

The Validity of a Continuous Glucose Monitor in Diagnosing Gestational Diabetes: A Pilot Study

Acronym: VALID

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 5, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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