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Continuous Glucose Monitor

Real time continuous glucose monitoring for Gestational Diabetes

N/A
Waitlist Available
Led By Malgorzata Mlynarczyk, MD, PhD
Research Sponsored by Eastern Virginia Medical School
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 9 months
Awards & highlights

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

Eligible Conditions
  • Gestational Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Blood Glucose
Secondary study objectives
3rd or 4th degree perineal laceration
Admission to neonatal intensive care unit
BMI at time of delivery
+19 more

Trial Design

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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous glucose monitoring
2019
N/A
~610

Find a Location

Who is running the clinical trial?

Eastern Virginia Medical SchoolLead Sponsor
72 Previous Clinical Trials
15,679 Total Patients Enrolled
MedtronicIndustry Sponsor
613 Previous Clinical Trials
759,693 Total Patients Enrolled
Malgorzata Mlynarczyk, MD, PhDPrincipal InvestigatorEastern Virginia Medical School
~5 spots leftby Sep 2025