Real-time Continuous Glucose Monitoring
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 11/25/2017 |
| Start Date: | November 13, 2017 |
| End Date: | July 2018 |
| Contact: | Joanne Audouin, MS |
| Email: | audouij@evms.edu |
| Phone: | 757-446-5121 |
Real-time Continuous Glucose Monitoring for the Treatment of Gestational Diabetes: a Randomized 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
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
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
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
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
We found this trial at
1
site
Norfolk, Virginia 23507
Principal Investigator: Malgorzata Mlynarczyk, MD, PhD
Phone: 757-446-5121
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