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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)
Must not have
Skin conditions which prevent wearing a continuous glucose monitor
History of pregestational type 2 diabetes mellitus
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
No Placebo-Only Group

Summary

This trial uses a device to track blood sugar levels in women who had diabetes during pregnancy. These women are at high risk for developing type 2 diabetes later. The study aims to understand their blood sugar patterns after childbirth and improve screening methods for diabetes.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot wear a glucose monitor due to skin conditions.
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I have had type 2 diabetes before becoming pregnant.
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I have a history of prediabetes or polycystic ovarian syndrome.

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

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

Awards & Highlights

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

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).

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for gestational diabetes include lifestyle modifications, insulin therapy, and continuous glucose monitoring (CGM). Lifestyle modifications, such as diet and exercise, help improve insulin sensitivity and control blood glucose levels. Insulin therapy provides exogenous insulin to manage hyperglycemia when lifestyle changes are insufficient. CGM continuously tracks glucose levels, allowing for real-time adjustments in diet, activity, and insulin dosing. This is crucial for GDM patients as it helps maintain optimal glycemic control, reducing the risk of complications for both the mother and the fetus.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,344 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,557 Previous Clinical Trials
4,298,529 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
~0 spots leftby Dec 2024