Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy

Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy:A Comparative Effectiveness Randomized Control Trial (PRECISE)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Gestational Diabetes
• Intervention / Treatment: Device: Group 1: one-hour GCT; Device: Group 2: CGM placement

• Study Type: Interventional
• Enrollment (Anticipated): 816
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michal Fishel Bartal, MD; Phone Number: 713-500-6421; Email: Michal.F.Bartal@uth.tmc.edu
• Study Contact Backup: Name: Sarah Nazeer; Phone Number: 713-500-6412; Email: Sarah.A.Nazeer@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Sarah Nazeer; Phone Number: 713-500-6412; Email: Sarah.A.Nazeer@uth.tmc.edu
      • Contact: Michal F Bartal, MD; Phone Number: 713-500-6421; Email: Michal.F.Bartal@uth.tmc.edu
      • Sub-Investigator: Sean Blackwell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: one-hour Glucose tolerance test (GCT)	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.
Experimental: CGM screening	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of neonates that show Composite Adverse Neonatal Outcome such as 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 Composite Adverse Neonatal Outcome such as 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 Composite Adverse Neonatal Outcome such as birth injury	Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury	at time of birth
Number of neonates that show Composite Adverse Neonatal Outcome such as 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( upto 6 months from birth)
Number of neonates that show Composite Adverse Neonatal Outcome such as 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( upto 6 months from birth)
Number of fetal or neonatal deaths		within 28 days of birth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility as assessed by the number of participants who complete the CGM diagnostic testing		From enrollment to discharge( upto 6 months from birth)
Number of women that use diabetic medication during pregnancy	diabetic medication is described as any glycemic control agent	From enrollment to delivery
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	Pre term birth id described as delivery less than 37 weeks of gestation	at time of birth
Number of women that undergo induced labor		at time of birth
Number of women that experience pregnancy induced hypertension		From enrollment to discharge( upto 6 months from birth)
Number of women that experience Eclampsia: seizures		From enrollment to discharge( upto 6 months from birth)
Number of women admitted due to poor glucose control		From enrollment to discharge( upto 6 months from birth)
Number of women with Primary cesarean section		at time of birth
Number of women with Postpartum hemorrhage: defined as greater then 1000ml or need for blood transfusion		From enrollment to discharge( upto 6 months from birth)
Number of women with endometritis		From enrollment to discharge( upto 6 months from birth)
Number of women with wound complications		From enrollment to discharge( upto 6 months from birth)
Number of women with diagnosis of type 2 diabetes during postpartum		birth to 6 weeks postpartum
Number of neonates with Apgar score less than 7		5 minutes after birth
Number of neonates that are admitted to the Neonatal intensive care unit (NICU)		birth to discharge from NICU(upto 6 months after delivery)
NICU length of stay		day of NICU discharge(upto 6 months after delivery)
Number of neonates with hyperbilirubinemia requiring phototherapy		birth to discharge( upto 6 months from birth)
Number of neonates with need for intravenous glucose therapy		birth to discharge( upto 6 months from birth)
Number of neonates that are Small for gestational age	Small for gestational age, defined as a weight below 10th percentile of the expected value according to gestational age (using the nomogram published by Duryea EL et al)	at time of birth
Number of participants who breastfed their babies		upto 6 weeks postpartum
Number of participants who formula fed their babies		upto 6 weeks postpartum

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: DexCom, Inc.
• Investigators: Principal Investigator: Michal Fishel Bartal, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): August 1, 2025
• Study Completion (Anticipated): August 1, 2026

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 17, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: HSC-MS-22-0153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No