Clinical trial NCT05430204: Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy
Official title: Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy:A Comparative Effectiveness Randomized Control Trial (PRECISE)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2022-06-24
Enrollment: 816
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of neonates that show Composite Adverse Neonatal Outcome such as Large for gestational age(LGA)
timeFrame: at time of birth
measure: Number of neonates that show Composite Adverse Neonatal Outcome such as shoulder dystocia
timeFrame: at time of birth
measure: Number of neonates that show Composite Adverse Neonatal Outcome such as birth injury
timeFrame: at time of birth
measure: Number of neonates that show Composite Adverse Neonatal Outcome such as Neonatal hypoglycemia
timeFrame: from birth to discharge( upto 6 months from birth)
measure: Number of neonates that show Composite Adverse Neonatal Outcome such as respiratory distress
timeFrame: from birth to discharge( upto 6 months from birth)
measure: Number of fetal or neonatal deaths
timeFrame: within 28 days of birth
Secondary outcomes:
measure: Feasibility as assessed by the number of participants who complete the CGM diagnostic testing
timeFrame: From enrollment to discharge( upto 6 months from birth)
measure: Number of women that use diabetic medication during pregnancy
timeFrame: From enrollment to delivery
measure: Number of women that show Polyhydramnios during pregnancy not related to known fetal anomaly
timeFrame: From enrollment to delivery
measure: Number of women that have preterm birth
timeFrame: at time of birth
measure: Number of women that undergo induced labor
timeFrame: at time of birth
measure: Number of women that experience pregnancy induced hypertension
timeFrame: From enrollment to discharge( upto 6 months from birth)
measure: Number of women that experience Eclampsia: seizures
timeFrame: From enrollment to discharge( upto 6 months from birth)
measure: Number of women admitted due to poor glucose control
timeFrame: From enrollment to discharge( upto 6 months from birth)
measure: Number of women with Primary cesarean section
timeFrame: at time of birth
measure: Number of women with Postpartum hemorrhage: defined as greater then 1000ml or need for blood transfusion
timeFrame: From enrollment to discharge( upto 6 months from birth)
measure: Number of women with endometritis
timeFrame: From enrollment to discharge( upto 6 months from birth)
measure: Number of women with wound complications
timeFrame: From enrollment to discharge( upto 6 months from birth)
measure: Number of women with diagnosis of type 2 diabetes during postpartum
timeFrame: birth to 6 weeks postpartum
measure: Number of neonates with Apgar score less than 7
timeFrame: 5 minutes after birth
measure: Number of neonates that are admitted to the Neonatal intensive care unit (NICU)
timeFrame: birth to discharge from NICU(upto 6 months after delivery)
measure: NICU length of stay
timeFrame: day of NICU discharge(upto 6 months after delivery)
measure: Number of neonates with hyperbilirubinemia requiring phototherapy
timeFrame: birth to discharge( upto 6 months from birth)
measure: Number of neonates with need for intravenous glucose therapy
timeFrame: birth to discharge( upto 6 months from birth)
measure: Number of neonates that are Small for gestational age
timeFrame: at time of birth
measure: Number of participants who breastfed their babies
timeFrame: upto 6 weeks postpartum
measure: Number of participants who formula fed their babies
timeFrame: upto 6 weeks postpartum
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Michal Fishel Bartal, MD
role: PRINCIPAL_INVESTIGATOR
References: