Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy

The University of Texas System (UT)

Status: Active, not recruiting

Conditions: Gestational Diabetes

Treatments: Device: Group 2: CGM placement; Device: Group 1: one-hour GCT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05430204

HSC-MS-22-0153

Details and patient eligibility

About

The purpose of this study is to evaluate whether Continuous glucose monitoring (CGM) for diagnosis of gestational diabetes mellitus (GDM) improves maternal and neonatal outcomes related to GDM and to evaluate whether CGM for GDM diagnosis reduces the health system costs for mother-infant dyads compared to usual care

Enrollment: 816 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 24-30 weeks gestation undergoing GDM screening

Exclusion criteria

• Known diagnosis of Type I and II DM
• History of bariatric surgery
• Major fetal anomalies
• Unwilling to use CGM for GDM screening
• Incarcerated subjects
• History of allergic reaction to any of CGM metals or adhesives in contact with the skin

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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816 participants in 2 patient groups

one-hour Glucose tolerance test (GCT)

Active Comparator group

Treatment:

Device: Group 1: one-hour GCT

CGM screening

Experimental group

Treatment:

Device: Group 2: CGM placement