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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
Who can join
Ages 18 and older · Women
Full eligibility criteria
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 ineligible for the study based on the following exclusion criteria: * 1\) known diagnosis of type 1 diabetes or gestational diabetes * 2\) plan to receive prenatal care or delivery outside of UMMHC * 3\) inability to provide informed consent * 4\) multifetal gestation
About the study
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.
What is being tested
- Continuous Glucose Monitor (device)
- Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose) (device)
Sponsor: University of Massachusetts, Worcester · Participants: 180 · Started: May 23, 2024
Contact the study team
- Gianna L Wilkie, MD · Phone: 7743642523
Official record on ClinicalTrials.gov — NCT05317585
Locations in the U.S.
| Massachusetts | University of Massachusetts Memorial Medical Center, Worcester |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.