Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-03 @ 12:22 AM
Study NCT ID:
NCT01741467
Status:
COMPLETED
Last Update Posted:
2016-10-19
First Post:
2012-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Real Time Continuous Glucose Monitoring in Subjects With Pre-diabetes
Sponsor:
Walter Reed National Military Medical Center
Organization:
Study Overview
Official Title:
The Effect of Real Time Continuous Glucose Monitoring in Subjects With Pre-diabetes
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
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:
CGM PreDM
Brief Summary:
This study will investigate whether real-time continuous glucose monitoring can be used as a tool for behavior change in people with pre-diabetes.
Detailed Description:
The protocol is a prospective, non-blinded, randomized controlled study in persons with newly diagnosed pre-diabetes comparing the effects of real-time continuous glucose monitoring (RT-CGM) combined with diet and lifestyle education to those who have diet and lifestyle education alone. During a "wash-in" phase both groups will wear a masked CGM for 1 week at baseline and again after 12 weeks. Those randomized to the RT-CGM will wear it for 4 cycles of 2 week on/1 week off over the next 12 weeks. Both groups will follow-up with their primary care providers as clinically indicated over the next year with quarterly measurements of blood pressure, weight, and BMI. At the end of this period, they will wear a masked CGM for 1 week.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: