Continuous Glucose Monitor Use and Perinatal Outcomes Among Pregnant Women With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
University of Massachusetts, Worcester
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.
Description
A continuous glucose monitor (CGM) can provide detailed insight into daily glucose fluctuations and individual glucose patterns, and it is advised for patients with type 1 diabetes mellitus and advanced type 2 diabetes mellitus (T2DM). Despite this recommendation, pregnant women are not receiving the same standard of care. It has been studied minimally in pregnant women with T2DM, despite preliminary studies showing improvement in adverse perinatal outcomes and glycemic control among pregnant women with type 1 diabetes. Therefore, there is a paucity of data regarding CGM use among pregnant wom…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: Women will be deemed eligible for the study by the following inclusion criteria: * 1\) age greater than or equal to 18 years old * 2\) singleton gestation less than or equal to 14 weeks at initial obstetric visit * 3\) 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 * 4\) receiving prenatal care at UMASS Memorial Health Care (UMMHC) and plans to deliver at UMMHC * 5\) able and willing to provide informed consent Exclusion Criteria: Women will be deemed ineligi…
Interventions
- DeviceContinuous Glucose Monitor
Continuous Glucose Monitor
- DeviceRoutine Capillary Blood Glucose Monitoring (Fingerstick Glucose)
Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)
Location
- University of Massachusetts Memorial Medical CenterWorcester, Massachusetts