Recruiting

Continuous Glucose Monitoring

Sponsor:

Eastern Virginia Medical School

Code:

NCT03326232

Conditions

Gestational Diabetes

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Continuous glucose monitoring

Study Details

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 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

Conditions

Gestational Diabetes

Study ID

NCT03326232

Start date

Nov 13, 2017

Status verified date

Nov, 2017

Completion date

Jul, 2018

Anticipated

Primary completion date

Jul, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Blinded continuous glucose monitoring

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

experimental: Real time continuous glucose monitoring

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)

Interventions

Continuous glucose monitoring

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

Primary outcome measure

  • Mean blood glucose (mg/dL) [ Time Frame: week 1 vs. week 4 ]

Central Contacts and Locations

Central contacts

Joanne Audouin, MS

757-446-5121audouij@evms.edu

Andrew Lane, MD

864-608-4134laneas@evms.edu

Locations

Eastern Virginia Medical School

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Joanne Audouin, MS

757-446-5121audouij@evms.edu

Andrew Lane, MD

864-608-4134laneas@evms.edu

Principal Investigator:

Malgorzata Mlynarczyk, MD, PhD

More Information

Sponsor

Eastern Virginia Medical School

Last update posted

Nov 24, 2017

Last verified

Nov, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eastern Virginia Medical School on 2017-11-24.