Your session is about to expire
← Back to Search
Continuous Glucose Monitoring
Continuous Glucose Monitoring for Gestational Diabetes
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up birth to discharge( upto 6 months from birth)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ birth to discharge( upto 6 months from birth)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~birth to discharge( upto 6 months from birth)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of fetal or neonatal deaths
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
+3 moreSecondary outcome measures
Feasibility as assessed by the number of participants who complete the CGM diagnostic testing
NICU length of stay
Number of neonates that are Small for gestational age
+18 moreOther outcome measures
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 moreTrial 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
137 Previous Clinical Trials
29,029 Total Patients Enrolled
The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,144 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not want to use continuous glucose monitoring for screening gestational diabetes.Pregnant individuals between 24 to 30 weeks of pregnancy getting checked for gestational diabetes.I have had weight loss surgery in the past.I have been diagnosed with Type 1 or Type 2 diabetes.People who are in prison.Severe birth defectsYou have had an allergic reaction to the metals or adhesives used in the CGM (Continuous Glucose Monitoring) system.
Research Study Groups:
This trial has the following groups:- Group 1: one-hour Glucose tolerance test (GCT)
- Group 2: CGM screening
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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!"
Answered by AI
Popular Categories
Share this study with friends
Copy Link
Messenger