Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy

Not Applicable

Active, not recruiting

• Conditions: Gestational Diabetes

• Registration Number: NCT05430204
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-24
• Study Start: 2023-03-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-10
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 816

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of neonates that show Composite Adverse Neonatal Outcome such as Neonatal hypoglycemia	from birth to discharge( upto 6 months from birth)	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
Number of neonates that show Composite Adverse Neonatal Outcome such as Large for gestational age(LGA)	at time of birth	LGA is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al)
Number of neonates that show Composite Adverse Neonatal Outcome such as shoulder dystocia	at time of birth	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
Number of neonates that show Composite Adverse Neonatal Outcome such as birth injury	at time of birth	Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury
Number of neonates that show Composite Adverse Neonatal Outcome such as respiratory distress	from birth to discharge( upto 6 months from birth)	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
Number of fetal or neonatal deaths	within 28 days of birth

Secondary Outcome Measures

Name	Time	Method
Number of women that show Polyhydramnios during pregnancy not related to known fetal anomaly	From enrollment to delivery
Number of women that undergo induced labor	at time of birth
NICU length of stay	day of NICU discharge(upto 6 months after delivery)
Number of participants who formula fed their babies	upto 6 weeks postpartum
Number of women that use diabetic medication during pregnancy	From enrollment to delivery	diabetic medication is described as any glycemic control agent
Number of women that have preterm birth	at time of birth	Pre term birth id described as delivery less than 37 weeks of gestation
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 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 neonates with need for intravenous glucose therapy	birth 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 with hyperbilirubinemia requiring phototherapy	birth to discharge( upto 6 months from birth)
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 admitted due to poor glucose control	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 neonates that are admitted to the Neonatal intensive care unit (NICU)	birth to discharge from NICU(upto 6 months after delivery)
Number of neonates that are Small for gestational age	at time of birth	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)
Number of participants who breastfed their babies	upto 6 weeks postpartum

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States