Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Device: Continuous glucose monitor
* Device: Traditional glucometer


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Glucose Monitoring Arm<br>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<br>* 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.<br>* Other names: Flash-glucose monitor;|
| Active Comparator: Traditional Glucometer Arm<br>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<br>* A traditional glucometer device will be assigned in the standard of care arm of this study for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Blood glucose capture rate | Number of days without any blood glucose recordings will be captured as a percentage over the study period. | 6 months | 
| 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 |