Status:
UNKNOWN
Real-time Continuous Glucose Monitoring
Lead Sponsor:
Eastern Virginia Medical School
Collaborating Sponsors:
Medtronic
Conditions:
Gestational Diabetes
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
Gestational diabetes (GDM) is a condition of carbohydrate intolerance with onset or first recognition in pregnancy. The prevalence of GDM is as high as 25% in some populations and continues to rise wi...
Detailed Description
The investigators' proposed study will add new information to the emerging use of CGM in pregnant women with GDM. First, most studies only use CGM for 48 - 72hours at a time, while the investigators w...
Eligibility Criteria
Inclusion
- maternal age 18 to 45
- singleton gestation
- gestational age less than 32 weeks gestation at study inclusion
- BMI less than 45
- 50g glucose challenge greater than 135 mg/dL
- 100 g 3 hr oral glucose tolerance test greater than 2 abnormal values using the Carpenter Coustan cut offs (fasting greater than 95 mg/dL, 1 hr greater than 180 mg/dL, 2 hr greater than 155 mg/dL, 3 hr greater than 140 mg/dL)
- attended the maternal-fetal medicine diabetes education class
Exclusion
- maternal age less than18 or greater than 45
- multifetal gestation
- gestational age greater than 32 weeks study inclusion
- BMI greater than 45
- pregestational diabetes
- gestational diabetes diagnosed before 24 weeks
- did not attend the diabetes education class
- known fetal anomaly
- known fetal aneuploidy
- required ongoing treatment with medications that can exacerbate hyperglycemia (steroids, hydroxyprogesterone caproate injections (Makena), highly active antiretroviral therapy HIV medications)
- learning disability
- concern for non compliance with medical care
- imminent preterm delivery due to maternal disease or fetal conditions
- is not willing to wear CGM
Key Trial Info
Start Date :
November 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03326232
Start Date
November 13 2017
End Date
July 1 2018
Last Update
November 24 2017
Active Locations (1)
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1
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507