Real-time Continuous Glucose Monitoring

Status Recruiting

Clinical Trial 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

Clinical Trial 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 will be using CGM for 7 day intervals. Both groups will use the same Enlite sensor (Medtronic). The blinded CGM group will be using the Medtronic iPro2 system (Enlite sensor + transmitter). The real-time CGM group will be using the 530g system (iPro2 (Enlite sensor + transmitter) + inactivated 530g pump set only to display glucose values, no insulin will be administered). This CGM system has been FDA approved to for up to 7 days between sensor changes.26,27 Second, no previous study has used real time CGM in pregnant patients with GDM in the US. The investigators will be the first to describe the use of this technology in this patient population. Third, most of these trials have been performed on populations that are not representative of the investigators' patient population at EVMS. This will be the largest US study of CGM in GDM. Fourth wearable medical and fitness technology is already popular, but as both the technology and the demand continues to grow, it will become the future of diabetes management. Studies have already shown that real time CGM is an effective educational and motivational tool in type-1 and type-2 DM.28,29 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03326232
Study type	Interventional
Source	Eastern Virginia Medical School
Contact	Joanne Audouin, MS
Phone	757-446-5121
Email	audouij@evms.edu
Status	Recruiting
Phase	N/A
Start date	November 13, 2017
Completion date	July 2018

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.