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Continuous Glucose Monitoring for Gestational Diabetes (CAPO Trial)

N/A

Recruiting

Led By Audrey Merriam, MD, MS

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women between 18-50 years old

Be between 18 and 65 years old

Must not have

Fetal growth restriction diagnosed during the current pregnancy

Abnormal diagnostic genetic testing or genetic screening for the fetus in the current pregnancy prior to randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment, through delivery by 40 weeks gestation and the immediate postpartum hospitalization up to 7 days postpartum

Awards & highlights

No Placebo-Only Group

Summary

This trial will use continuous glucose monitoring to see if it lowers the rate of serious complications in women with A2 gestational diabetes.

Who is the study for?

This trial is for pregnant women aged 18-50 with a single baby and diagnosed with A2 gestational diabetes needing medication, between 24-36 weeks of pregnancy. It's not for those with pregestational diabetes, multiple babies, fetal growth issues, or certain medical conditions like lupus or chronic hypertension.

What is being tested?

The study compares the effects of continuous glucose monitoring versus routine fingerstick blood checks four times daily in managing A2 gestational diabetes during pregnancy. The goal is to see if constant monitoring can reduce complications such as high birth weight and neonatal hypoglycemia.

What are the potential side effects?

While the trial itself does not list specific side effects, continuous glucose monitoring generally has minimal risks which may include skin irritation from the sensor adhesive or discomfort at the sensor site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged between 18 and 50.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My current pregnancy has been diagnosed with fetal growth restriction.

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My current pregnancy has shown abnormal genetic test results for the fetus.

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I have been diagnosed with too much amniotic fluid.

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I have a health condition such as lupus, high blood pressure, cancer, or heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment, through delivery by 40 weeks gestation and the immediate postpartum hospitalization up to 7 days postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment, through delivery by 40 weeks gestation and the immediate postpartum hospitalization up to 7 days postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment, through delivery by 40 weeks gestation and the immediate postpartum hospitalization up to 7 days postpartum for reporting.