Continuous Glucose Monitor Use in Pregnancy
Recruiting · NCT05317585 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Massachusetts, Worcester
View the official record on ClinicalTrials.gov →Interventions studied
Continuous Glucose MonitorRoutine Capillary Blood Glucose Monitoring (Fingerstick Glucose)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- University of Massachusetts Memorial Medical Center - Worcester, Massachusetts, United States