Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients

Type 2 Diabetes Clinical Trial

Official title:

Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05766488
• Other study ID #: 0314-22-FB
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: March 2024

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 perceived/expected 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 don't differ from usual diabetes care Researchers will compare the CGM group to the traditional glucometer group to see if there are differences between (1) perceived/experienced benefits or barriers to the use of these devices, (2) glycemic clinical outcomes (hemoglobin A1c, hypoglycemia, hyperglycemia), and (3) glycemic measurement frequency.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Type 2 diabetes
• A1c >9% at recruitment • On/initiating insulin or on two or more diabetes medications

Exclusion Criteria:

• Current use of an insulin pump
• On dialysis
• Pregnant
• With an implanted medical device (e.g., pace-maker, defibrillator)
• Intellectual or physical disabilities (i.e., cognitive or physical) that may interfere with the patient's ability to properly use the CGM
• Language difficulties (must understand and be able to read English)

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Device:
• Continuous glucose monitor
A continuous glucose monitor will be provided in the experimental arm of this study for 6 months. This monitor will be a Freestyle Libre 2 device.
• Traditional glucometer
A traditional glucometer device will be assigned in the standard of care arm of this study for 6 months.

Locations

Country	Name	City	State
United States	Nebraska Medicine	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	Great Plains IDeA-CTR

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	Glycemic control will be assessed using hemoglobin A1c. A1c values closest to baseline, 3 months, and 6 months of follow-up will be captured and evaluated as a continuous variable and categorized as <7.0% vs >7.0% to <9.0% and >9.0%.	6 months
Secondary	Hypoglycemia	CGM and glucometer blood glucose data will be evaluated to determine number and percentage of hypoglycemic readings (i.e., <70 mg/dL). For CGM data, % time within target range, % time below specific thresholds for hypoglycemia) will be captured and described.	6 months
Secondary	Hyperglycemia	CGM and glucometer blood glucose data will be evaluated to determine percentage of hyperglycemic values (i.e., >180 mg/dl) experienced. For CGM data, % time within target range, % time below specific thresholds for hypoglycemia) will be captured and described.	6 months
Secondary	Blood glucose capture rate	Number of days without any blood glucose recordings will be captured as a percentage over the study period.	6 months
Secondary	Perceived or experienced benefits and barriers to device use	A pre- and post-survey will be provided to all participants to qualitatively identify benefits and barriers to access and use of their assigned device and willingness to continue CGM use (follow-up survey).	6 months