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
University of Massachusetts, Worcester
180 participants
May 23, 2024
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
Inclusion Criteria5
- \) age greater than or equal to 18 years old
- \) singleton gestation less than or equal to 14 weeks at initial obstetric visit
- \) established diagnosis of T2DM by laboratory criteria including hemoglobin A1c ≥6.5%, oral glucose tolerance test ≥200 mg/dL, or fasting plasma glucose ≥126 mg/dL
- \) receiving prenatal care at UMASS Memorial Health Care (UMMHC) and plans to deliver at UMMHC
- \) able and willing to provide informed consent
Exclusion Criteria4
- \) known diagnosis of type 1 diabetes or gestational diabetes
- \) plan to receive prenatal care or delivery outside of UMMHC
- \) inability to provide informed consent
- \) multifetal gestation
Interventions
Continuous Glucose Monitor
Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)
Locations(1)
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NCT05317585