RecruitingNot ApplicableNCT05317585

Continuous Glucose Monitor Use in Pregnancy

Continuous Glucose Monitor Use and Perinatal Outcomes Among Pregnant Women With Type 2 Diabetes Mellitus: A Randomized Controlled Trial


Sponsor

University of Massachusetts, Worcester

Enrollment

180 participants

Start Date

May 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to perform a randomized controlled trial among 180 pregnant women with type 2 diabetes mellitus (T2DM) comparing continuous glucose monitor (CGM) use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using a continuous glucose monitor (CGM) — a small wearable sensor that tracks blood sugar levels in real time — during pregnancy improves blood sugar control and pregnancy outcomes for women with type 2 diabetes. **You may be eligible if...** - You are 18 or older - You are pregnant with a single baby and are at 14 weeks of pregnancy or earlier at your first prenatal visit - You have type 2 diabetes confirmed by lab tests (HbA1c ≥6.5%, glucose tolerance test ≥200 mg/dL, or fasting glucose ≥126 mg/dL) - You receive prenatal care at UMass Memorial Health Care and plan to deliver there **You may NOT be eligible if...** - You have type 1 diabetes or gestational diabetes (not pre-existing type 2) - You are already using a continuous glucose monitor - You are carrying multiple babies (twins, triplets, etc.) - You have serious medical conditions that complicate your pregnancy beyond diabetes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEContinuous Glucose Monitor

Continuous Glucose Monitor

DEVICERoutine Capillary Blood Glucose Monitoring (Fingerstick Glucose)

Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)


Locations(1)

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

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NCT05317585


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