Ignite Creation Date:
2024-05-06 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03326232
Status:
UNKNOWN
Last Update Posted:
2017-11-24
First Post:
2017-10-25
Brief Title:
Real-time Continuous Glucose Monitoring
Sponsor:
Eastern Virginia Medical School
Organization:
Eastern Virginia Medical School
Study Overview
Official Title:
Real-time Continuous Glucose Monitoring for the Treatment of Gestational Diabetes a Randomized Trial
Status:
UNKNOWN
Status Verified Date:
2017-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed 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 changes2627 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 DM2829
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None