Real-time Continuous Glucose Monitoring

Status unconfirmed · Not applicable

Conditions studied: Gestational Diabetes

In brief

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 with the increase in obesity and type-2 diabetes. GDM places the pregnancy at great risk to both the mother and the neonate. Recent studies have proven that interventions including dietary and medications lower the risk to the pregnancy. Both the American College of Obstetrics and Gynecology (ACOG) and the American Diabetes Association (ADA) recommend dietary interventions with daily glucose monitoring as the initial treatment of choice. Meanwhile, outside of pregnancy, promising new technologies such as continuous glucose monitors (CGM) are revolutionizing diabetic care. The investigators seek to determine if the constant feedback of a real-time CGM system would improve glycemic control compared to traditional management in GDM

Key facts

Study ID

NCT03326232

Run by

Eastern Virginia Medical School

People needed

40

Starts

2017-11-13

Expected to finish

2018-07-01

Last updated by the study team

2017-11-24

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Eastern Virginia Medical School — Norfolk, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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