Gestational Diabetes Mellitus (GDM)
Conditions
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.
Interventions
DEVICEContinuous 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.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTNicola F Tavella, MPH
CONTACTVictoria Ly, MD
PRINCIPAL_INVESTIGATORAngela Bianco, MD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed