Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05766488
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-24
First Post:
2023-02-27
Brief Title:
Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
IRB protocol approval expired Continuing Review not submitted
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the perceived and experienced benefits and barriers of Continuous Glucose Monitor CGM use and identify outcomes associated with CGM use relative to usual care with self-monitoring of blood glucose in an underserved patient population with type 2 diabetes
Detailed Description:
The goal of this clinical trial is to evaluate the perceived and experienced benefits and barriers of CGM use and identify outcomes associated with CGM use relative to usual care with self-monitoring of blood glucose in an underserved patient population with type 2 diabetes The main questions it aims to answer are
What are the perceived and experienced benefits of CGM use in an underserved patient population with type 2 diabetes
What differences are there in glucose monitoring frequency and glucose control between CGM and traditional glucometer testing in an underserved patient population with type 2 diabetes
Participants will
Complete a baseline and final survey evaluating perceivedexpected benefits or barriers to CGM use
Be assigned to a CGM or usual care traditional glucometer arm for 6 months within an interprofessional primary care setting
Complete laboratory testing at regular intervals that dont differ from usual diabetes care
Researchers will compare the CGM group to the traditional glucometer group to see if there are differences between 1 perceivedexperienced benefits or barriers to the use of these devices 2 glycemic clinical outcomes hemoglobin A1c hypoglycemia hyperglycemia and 3 glycemic measurement frequency
What are the perceived and experienced benefits of CGM use in an underserved patient population with type 2 diabetes
What differences are there in glucose monitoring frequency and glucose control between CGM and traditional glucometer testing in an underserved patient population with type 2 diabetes
Participants will
Complete a baseline and final survey evaluating perceivedexpected benefits or barriers to CGM use
Be assigned to a CGM or usual care traditional glucometer arm for 6 months within an interprofessional primary care setting
Complete laboratory testing at regular intervals that dont differ from usual diabetes care
Researchers will compare the CGM group to the traditional glucometer group to see if there are differences between 1 perceivedexperienced benefits or barriers to the use of these devices 2 glycemic clinical outcomes hemoglobin A1c hypoglycemia hyperglycemia and 3 glycemic measurement frequency
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?:
True
Is an FDA AA801 Violation?:
None