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Glucose Tolerance Test + Continuous Glucose Monitoring for Postpartum High Blood Sugar

N/A
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Gestational diabetes mellitus identified at < 20 weeks' gestation requiring pharmacologic treatment (class A2) (for early GDM women)
Gestational diabetes mellitus identified at >= 24 weeks' gestation requiring pharmacologic treatment (class A2) (for 3rd trimester GDM women)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery
Awards & highlights

Study Summary

This trial is looking at a new way to screen for type 2 diabetes in women who are at high risk. The goal is to improve diagnostic strategies.

Who is the study for?
This trial is for women who had gestational diabetes during a single pregnancy with no fetal anomalies, diagnosed before 20 weeks or at/after 24 weeks and required medication. It's not for those with skin conditions affecting glucose monitor use, history of prediabetes, PCOS, or pregestational type 2 diabetes.Check my eligibility
What is being tested?
The study tests how well two methods can track blood sugar levels after childbirth in women at risk for long-term high blood sugar. One method is a standard oral glucose tolerance test; the other uses a Dexcom G6 Pro continuous glucose monitor.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the continuous glucose monitor on the skin and possible reactions to the oral glucose solution like nausea or bloating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was diagnosed with gestational diabetes before 20 weeks of pregnancy and needed medication.
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I was diagnosed with gestational diabetes needing medication after 24 weeks of pregnancy.
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I am 34-40 weeks pregnant with one healthy baby.
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I am 34-40 weeks pregnant with one healthy baby.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Maternal and infant body fat composition
Maternal diabetes mellitus
Maternal glucose variability
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Postpartum GDMExperimental Treatment1 Intervention
Women with GDM diagnosed early (< 20 weeks gestation) or with routine 3rd trimester screening (>=24 weeks) will be enrolled in this longitudinal study. All enrolled women will complete a oral glucose tolerance test and wear a continuous glucose monitor for 10 days at the 3 designated study time points (0-4 days, 4-6 weeks, and 6 months after delivery).

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,571 Previous Clinical Trials
2,269,371 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,500 Previous Clinical Trials
4,176,678 Total Patients Enrolled

Media Library

2-hour 75-g oral glucose tolerance test Clinical Trial Eligibility Overview. Trial Name: NCT04521712 — N/A
Gestational Diabetes Research Study Groups: Postpartum GDM
Gestational Diabetes Clinical Trial 2023: 2-hour 75-g oral glucose tolerance test Highlights & Side Effects. Trial Name: NCT04521712 — N/A
2-hour 75-g oral glucose tolerance test 2023 Treatment Timeline for Medical Study. Trial Name: NCT04521712 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I register for this research project?

"This study is seeking 40 individuals with gestational diabetes, aged 18 to 45. The primary eligibility criteria includes being a singleton gestation without any fetal abnormalities at 34-40 weeks of pregnancy."

Answered by AI

Is this research open to individuals aged 55 or older?

"As outlined in the study's eligibility criteria, prospective participants must fall between 18 and 45 years of age."

Answered by AI

What is the recruitment capacity for this clinical trial?

"Indeed, the information available on clinicaltrials.gov verifies that this trial is in need of volunteers. The study was first publicized on September 17th 2021 and its most recent update occurred on November 7th 2022. 40 participants are required to come from 2 separate sites for this experiment."

Answered by AI

Are new participants being accepted for this clinical investigation?

"Affirmative, the clinicaltrials.gov record shows that this research is currently seeking volunteers. The initial posting for the trial was on September 17th 2021 and it has been adjusted as recently as November 7th 2022. 40 participants need to be enrolled from 2 different sites."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
University of North Carolina at Chapel Hill
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
~8 spots leftby Dec 2024