Study Summary
This trial will compare whether using CGM to diagnose GDM results in better outcomes and cost savings compared to usual care.
Eligible Conditions
- Gestational Diabetes
Treatment Effectiveness
Effectiveness Progress
Study Objectives
6 Primary · 21 Secondary · Reporting Duration: Birth to discharge( upto 6 months from birth)
5 minutes after birth
Number of neonates with Apgar score less than 7
Week 6
Incremental cost for prevention of Type II DM in life using a model method.
Month 6
Risk factors associated with neonatal hypoglycemia.
Month 6
Blood sugars using blinded CGM with 1-hour GCT results and composite maternal and neonatal adverse outcomes.
Evaluation of one abnormal value during 3-hour GTT and composite maternal and adverse outcomes.
Evaluation of one-hour screening GCT threshold and composite maternal and adverse outcomes.
Evaluation of time above range using CGM and associated neonatal outcomes.
Fetal growth or amniotic fluid abnormalities during third trimester ultrasound exam among GDM.
Gestational diabetic outcomes with and without Hypertensive Disorder of Pregnancy.
Maternal hypoglycemia using CGM and composite maternal and adverse outcomes.
Procedure specific satisfaction surveys
Risk factors and adverse outcomes associated with ultrasound diagnosed large for gestational age fetus.
Satisfaction with the screening method
The racial and ethnic disparity among gestational diabetics screening, diagnosis and treatment .
From enrollment to delivery
Number of women that show Polyhydramnios during pregnancy not related to known fetal anomaly
Number of women that use diabetic medication during pregnancy
Month 6
Feasibility as assessed by the number of participants who complete the CGM diagnostic testing
Number of women admitted due to poor glucose control
Number of women that experience Eclampsia: seizures
Number of women that experience pregnancy induced hypertension
Number of women with Postpartum hemorrhage: defined as greater then 1000ml or need for blood transfusion
Number of women with endometritis
Number of women with wound complications
Week 6
Labor and postpartum evaluation of blood sugars
at time of birth
Number of neonates that are Small for gestational age
Number of neonates that show Composite Adverse Neonatal Outcome such as Large for gestational age(LGA)
Number of neonates that show Composite Adverse Neonatal Outcome such as birth injury
Number of neonates that show Composite Adverse Neonatal Outcome such as shoulder dystocia
Number of women that have preterm birth
Number of women that undergo induced labor
Number of women with Primary cesarean section
Week 6
Number of women with diagnosis of type 2 diabetes during postpartum
Month 6
Number of neonates that are admitted to the Neonatal intensive care unit (NICU)
Month 6
Number of neonates with hyperbilirubinemia requiring phototherapy
Number of neonates with need for intravenous glucose therapy
Month 6
NICU length of stay
Month 6
Number of neonates that show Composite Adverse Neonatal Outcome such as Neonatal hypoglycemia
Number of neonates that show Composite Adverse Neonatal Outcome such as respiratory distress
upto 6 weeks postpartum
Number of participants who breastfed their babies
Number of participants who formula fed their babies
Day 28
Number of fetal or neonatal deaths
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
one-hour Glucose tolerance test (GCT)
1 of 2
CGM screening
1 of 2
Active Control
Experimental Treatment
816 Total Participants · 2 Treatment Groups
Primary Treatment: Group 2: CGM placement · No Placebo Group · N/A
CGM screening
Device
Experimental Group · 1 Intervention: Group 2: CGM placement · Intervention Types: Deviceone-hour Glucose tolerance test (GCT)
Device
ActiveComparator Group · 1 Intervention: Group 1: one-hour GCT · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: birth to discharge( upto 6 months from birth)
Who is running the clinical trial?
DexCom, Inc.Industry Sponsor
128 Previous Clinical Trials
28,084 Total Patients Enrolled
The University of Texas Health Science Center, HoustonLead Sponsor
817 Previous Clinical Trials
258,212 Total Patients Enrolled
Michal Fishel Bartal, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
2 Previous Clinical Trials
178 Total Patients Enrolled
Eligibility Criteria
Age 18+ · Female Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Does the clinical trial remain accessible to participants?
"According to clinicaltrials.gov, this medical trial is not actively enrolling new patients at the moment. The first post date was August 1st 2022 and the last update occured on June 17th of that same year. However, there are an abundance of other trials seeking participants as we speak - 1200 in total!" - Anonymous Online Contributor
Unverified Answer