Real-time Continuous Glucose Monitoring

Recruiting in Palo Alto (17 mi)

Overseen byMalgorzata Mlynarczyk, MD, PhD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Eastern Virginia Medical School

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Research Team

Malgorzata Mlynarczyk, MD, PhD

Principal Investigator

Eastern Virginia Medical School

Eligibility Criteria

Inclusion Criteria

maternal age 18 to 45

singleton gestation

gestational age less than 32 weeks gestation at study inclusion

See 4 more

Treatment Details

Interventions

Continuous glucose monitoring (Continuous Glucose Monitor)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Real time continuous glucose monitoringExperimental Treatment1 Intervention

The real-time CGM group will be using the 530g system (inactivated 530g insulin pump (no insulin used, only used as display for CGM), Enlite sensor, MiniLink transmitter)

Group II: Blinded continuous glucose monitoringExperimental Treatment1 Intervention

The blinded CGM group will be using the Medtronic iPro2 system (Enlite sensor + iPro2 transmitter).