Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients
- Conditions
- Type 2 Diabetes
- Interventions
- Device: Continuous glucose monitorDevice: Traditional glucometer
- Registration Number
- NCT05766488
- Lead Sponsor
- University of Nebraska
- 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 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 & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 50
- Type 2 diabetes
- A1c >9% at recruitment • On/initiating insulin or on two or more diabetes medications
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continuous Glucose Monitoring Arm Continuous glucose monitor 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. Traditional Glucometer Arm Traditional glucometer 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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).
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.
Trial Locations
- Locations (1)
Nebraska Medicine
🇺🇸Omaha, Nebraska, United States