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Continuous Glucose Monitoring

Continuous Glucose Monitoring for Gestational Diabetes

N/A
Waitlist Available
Led By Michal Fishel Bartal, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
History of bariatric surgery
Known diagnosis of Type I and II DM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up birth to discharge( upto 6 months from birth)
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare whether using CGM to diagnose GDM results in better outcomes and cost savings compared to usual care.

Who is the study for?
This trial is for pregnant women between 24-30 weeks gestation who are being screened for gestational diabetes. It's not open to those with a known diagnosis of Type I or II diabetes, history of bariatric surgery, major fetal anomalies, or allergies to CGM components.
What is being tested?
The study compares two methods: Group 1 will undergo the standard one-hour Glucose Challenge Test (GCT), while Group 2 will use Continuous Glucose Monitoring (CGM) devices. The goal is to see if CGM can improve outcomes and reduce healthcare costs.
What are the potential side effects?
Potential side effects from using a CGM may include skin irritation or allergic reactions where the device attaches to the skin due to its metals or adhesives.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had weight loss surgery in the past.
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I have been diagnosed with Type 1 or Type 2 diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~birth to discharge( upto 6 months from birth)
This trial's timeline: 3 weeks for screening, Varies for treatment, and birth to discharge( upto 6 months from birth) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 Neonatal hypoglycemia
Number of neonates that show Composite Adverse Neonatal Outcome such as birth injury
+2 more
Secondary study objectives
Number of neonates that are Small for gestational age
Number of women that have preterm birth
Number of women that use diabetic medication during pregnancy
Other study objectives
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.
+11 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CGM screeningExperimental Treatment1 Intervention
Group II: one-hour Glucose tolerance test (GCT)Active Control1 Intervention

Find a Location

Who is running the clinical trial?

DexCom, Inc.Industry Sponsor
144 Previous Clinical Trials
34,669 Total Patients Enrolled
The University of Texas Health Science Center, HoustonLead Sponsor
946 Previous Clinical Trials
343,473 Total Patients Enrolled
Michal Fishel Bartal, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
2 Previous Clinical Trials
178 Total Patients Enrolled

Media Library

CGM (Continuous Glucose Monitoring) Clinical Trial Eligibility Overview. Trial Name: NCT05430204 — N/A
Gestational Diabetes Research Study Groups: one-hour Glucose tolerance test (GCT), CGM screening
Gestational Diabetes Clinical Trial 2023: CGM Highlights & Side Effects. Trial Name: NCT05430204 — N/A
CGM (Continuous Glucose Monitoring) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05430204 — N/A
~39 spots leftby Jan 2025
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