Continuous Glucose Monitoring for Type 2 Diabetes in Pregnancy (CGM2 Trial)

N/A

Waitlist Available

Led By Ashley Battarbee, MD, MSCR

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

Pregnant with viable fetus at 6 to less than 23 weeks gestation

Maternal age 18-50 years old

Must not have

Patient unable to consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of delivery to the date of neonatal hospital discharge, assessed up to 12 months of life

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to determine if continuous glucose monitoring is more effective than traditional fingerstick monitoring in treating type 2 diabetes during pregnancy. It also seeks to identify all risk factors for complications in both mothers and

Who is the study for?

This trial is for pregnant individuals with type 2 diabetes. They should be willing to monitor their blood sugar levels using either continuous glucose monitoring (CGM) or traditional fingerstick tests throughout pregnancy and provide blood samples.

What is being tested?

The study compares the effectiveness of continuous glucose monitoring (CGM) versus self-monitoring of blood glucose in managing type 2 diabetes during pregnancy, focusing on both infant and maternal outcomes.

What are the potential side effects?

While CGM itself has minimal side effects, potential discomforts may include skin irritation from the sensor adhesive or inconvenience due to carrying the device. Blood draws may cause bruising or pain at the puncture site.

Eligibility Criteria

Inclusion Criteria

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

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I am pregnant and between 6 to less than 23 weeks along.

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I am a woman aged between 18 and 50.

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I have type 2 diabetes, use insulin or pills, and had an A1c of 6.5% or higher before or early in pregnancy.

Exclusion Criteria

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

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I am unable to give consent for medical procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of delivery to the date of neonatal hospital discharge, assessed up to 12 months of life

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of delivery to the date of neonatal hospital discharge, assessed up to 12 months of life

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of delivery to the date of neonatal hospital discharge, assessed up to 12 months of life for reporting.