Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients

Sponsor

University of Nebraska (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05766488

Collaborator

Great Plains IDeA-CTR (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Device: Continuous glucose monitor Device: Traditional glucometer	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be assigned into one of two groups and receive either the treatment intervention (CGM) or standard of care intervention (traditional glucometer) simultaneously upon enrollment.Participants will be assigned into one of two groups and receive either the treatment intervention (CGM) or standard of care intervention (traditional glucometer) simultaneously upon enrollment.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Continuous Glucose Monitoring Arm Participants in this arm will use a Freestyle Libre 2 monitoring device for 6 months to track their blood glucose levels while receiving usual patient care within an interprofessional primary care team.	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. Other Names: Flash-glucose monitor
Active Comparator: Traditional Glucometer Arm Participants in this arm will use a traditional glucose monitoring device (glucometer) to self-monitor their blood glucose for 6 months while receiving usual patient care within an interprofessional primary care team.	Device: Traditional glucometer A traditional glucometer device will be assigned in the standard of care arm of this study for 6 months.

Arm

Intervention/Treatment

Experimental: Continuous Glucose Monitoring Arm

Participants in this arm will use a Freestyle Libre 2 monitoring device for 6 months to track their blood glucose levels while receiving usual patient care within an interprofessional primary care team.

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.

Other Names:

Flash-glucose monitor

Active Comparator: Traditional Glucometer Arm

Participants in this arm will use a traditional glucose monitoring device (glucometer) to self-monitor their blood glucose for 6 months while receiving usual patient care within an interprofessional primary care team.

Device: Traditional glucometer

A traditional glucometer device will be assigned in the standard of care arm of this study for 6 months.

Outcome Measures

Primary Outcome Measures

Hemoglobin A1c [6 months]
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%.

Secondary Outcome Measures

Hypoglycemia [6 months]
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.
Hyperglycemia [6 months]
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.
Blood glucose capture rate [6 months]
Number of days without any blood glucose recordings will be captured as a percentage over the study period.
Perceived or experienced benefits and barriers to device use [6 months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Nebraska
Great Plains IDeA-CTR

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Drew Prescott, Clinical Assistant Professor, University of Nebraska

ClinicalTrials.gov Identifier:

NCT05766488

Other Study ID Numbers:

0314-22-FB

First Posted:

Mar 13, 2023

Last Update Posted:

Mar 13, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Study Results

No Results Posted as of Mar 13, 2023