What side effects are associated with this type of intervention?

The most common treatments for gestational diabetes include lifestyle modifications, insulin therapy, and metformin. Lifestyle modifications generally have minimal side effects but can be challenging to maintain. Insulin therapy can cause hypoglycemia (low blood sugar), weight gain, and injection site reactions. Metformin, an oral medication, may lead to gastrointestinal issues such as nausea, diarrhea, and abdominal discomfort. Continuous glucose monitoring itself is generally safe but may cause skin irritation at the sensor site.

What prior FDA approvals exist?

The provided context does not specify any FDA-approved treatments specifically for gestational diabetes. However, it does mention the use of continuous glucose monitoring (CGM) as a technology that may be useful in identifying women with persistent hyperglycemia postpartum. CGM can help in understanding maternal glycemia and the physiology driving glycemia in the postpartum period, which is crucial for managing gestational diabetes and preventing the progression to type 2 diabetes mellitus.

What other types of research exist?

Promising alternatives to Continuous Glucose Monitoring for gestational diabetes patients include the use of advanced telemedicine platforms that integrate remote patient monitoring with virtual consultations. These platforms can provide real-time feedback and personalized treatment adjustments. Additionally, novel pharmacological treatments such as GLP-1 receptor agonists (e.g., semaglutide) and SGLT2 inhibitors, which have shown efficacy in managing blood glucose levels, may reduce the need for continuous monitoring. However, their use in gestational diabetes specifically would require further validation.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery

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).

0 / 6Eligibility criteria met

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.