Continuous Glucose Monitor Use in Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Massachusetts, Worcester
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Continuous Glucose Monitor
- Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)
Treatment groups
180 Participants
are divided into 2 treatment groupsLocations
1University of Massachusetts Memorial Medical Center01605, WorcesterMassachusetts, United States
Sponsors and collaborators
University of Massachusetts, Worcester
Lead sponsor
Source ClinicalTrials.gov