Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy

NAActive, not recruitingINTERVENTIONAL
Enrollment

816

Participants

Timeline

Start Date

March 7, 2023

Primary Completion Date

January 1, 2025

Study Completion Date

January 1, 2025

Conditions
Gestational Diabetes
Interventions
DEVICE

Group 1: one-hour GCT

Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.

DEVICE

Group 2: CGM placement

"CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group:~* Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or~* Average glucose≥130 mg/dL or~* Any glucose value ≥200 mg/dL"

Trial Locations (1)

77030

The University of Texas Health Science Center at Houston, Houston

All Listed Sponsors
collaborator

DexCom, Inc.

INDUSTRY

lead

The University of Texas Health Science Center, Houston

OTHER