Validating CGM for GDM
ConditionGestational Diabetes Mellitus (GDM)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Ages 18-50
Singleton pregnancy between 24-32 weeks gestational age
Prenatal care and delivery at Mount Sinai Hospital
Disqualifiers
Multiple fetal gestation
Preexisting diabetes
Concurrent use of steroids
Anomalous fetus
Trial design
Design model
Single group
Treatments tested in this trial
Continuous glucose monitor
DeviceDevice is a remote sensor applied to the upper extremity that continuously samples glucose of interstitial fluid and uploading results to a mobile application.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Individuals receiving prenatal care at Mount Sinai HospitalExperimental treatment 1 intervention
Trial outcomes
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 testing2
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 hours3
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 childbirthSponsors and contacts
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Source ClinicalTrials.gov