Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy

NCT05430204 | Completed Results FDA Device

• 1 other identifier: HSC-MS-22-0153
• Study Type: interventional
• Target: 1,628
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (7)

• Number of Neonates That Show Composite Adverse Neonatal Outcome

  Composite adverse neonatal outcome include one or more of the following: * Large for Gestational Age(LGA) is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al) * Shoulder Dystocia is defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head to deliver the fetal body after the fetal head has been delivered * Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury * Neonatal hypoglycemia: less than 40 mg/dL in the first 24 hours of life and less than 50 mg/dL after or requiring medical therapy * Respiratory distress is described as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation at the first 24 hours of life * Fetal or neonatal death (within 28 days of birth)

  From birth to about 28 days of life.

• Number of Neonates That Show Adverse Neonatal Outcome of Large for Gestational Age(LGA)

  LGA is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al)

  at time of birth

• Number of Neonates That Show Adverse Neonatal Outcome of Shoulder Dystocia

  Shoulder dystocia is defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head to deliver the fetal body after the fetal head has been delivered

  at time of birth

• Number of Neonates That Show Adverse Neonatal Outcome of Birth Injury

  Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury

  at time of birth

• Number of Neonates That Show Adverse Neonatal Outcome of Neonatal Hypoglycemia

  Neonatal hypoglycemia: less than 40 mg/dL in the first 24 hours of life and less than 50 mg/dL after or requiring medical therapy

  from birth to discharge (about 3-15 days)

• Number of Neonates That Show Adverse Neonatal Outcome of Respiratory Distress

  Respiratory distress is described as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation at the first 24 hours of life

  from birth to discharge (about 3-15 days)

• Number of Fetal or Neonatal Deaths

  within 28 days of birth

Secondary Outcomes (31)

• Feasibility as Assessed by the Number of Participants Who Complete the CGM Diagnostic Testing

  From enrollment to 6 weeks post partum, on average 21 weeks

• Number of Women That Use Diabetic Medication During Pregnancy

  From enrollment to 6 weeks post partum, on average 21 weeks

• Number of Women That Show Polyhydramnios During Pregnancy Not Related to Known Fetal Anomaly

  From enrollment to delivery

• Number of Women That Have Preterm Birth

  at time of birth

• Number of Women That Undergo Induced Labor

  at time of birth

Study Arms (2)

one-hour Glucose tolerance test (GCT)

ACTIVE COMPARATOR

Device: Group 1: one-hour GCT

CGM screening

EXPERIMENTAL

Device: Group 2: CGM placement

Interventions

Group 1: one-hour GCT DEVICE

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.

one-hour Glucose tolerance test (GCT)

Group 2: CGM placement DEVICE

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

CGM screening

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• weeks gestation undergoing GDM screening

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• DexCom, Inc.: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Fishel Bartal M, Ashby Cornthwaite J, Ghafir D, Ward C, Nazeer SA, Blackwell SC, Pedroza C, Chauhan SP, Sibai BM. Continuous glucose monitoring in individuals undergoing gestational diabetes screening. Am J Obstet Gynecol. 2023 Oct;229(4):441.e1-441.e14. doi: 10.1016/j.ajog.2023.04.021. Epub 2023 Apr 23.

  PMID: 37088275 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Michal Fishel Bartal, MD
• Organization: The University of Texas Health Science Center at Houston

Michal.F.Bartal@uth.tmc.edu

713-500-6421

Study Officials

• Michal Fishel Bartal, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 24, 2022
• Study Start: March 7, 2023
• Primary Completion: August 2, 2024
• Study Completion: September 16, 2024
• Last Updated: December 4, 2025
• Results First Posted: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)