Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients
Part of paid clinical trials in Omaha, Nebraska.
- Sponsor
- University of Nebraska
- Study ID
- NCT05766488
- Status
- Enrolling By Invitation
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Continuous Glucose Monitor (CGM) — DEVICEA Freestyle Libre 2 continuous glucose monitor (CGM) will be provided in the experimental arm of this study for 6 months.
- Self-monitoring Blood Glucose (SMBG) — DEVICEA traditional glucometer device will be assigned in the active comparitor arm of this study for 6 months.
Study Details
Continuous glucose monitoring (CGM) has demonstrated improved outcomes in both type 1 and type 2 diabetes populations in comparison to traditional methods; however, these devices have not been well studied in underserved adult patients (e.g., low-income, uninsured) who may face additional barriers to monitoring. Furthermore, there is limited data exploring long-term (3- to 6- month) health care team-based management of these devices in the primary care setting. The purpose of this study is to further understand the benefits and barriers associated with CGM use in underserved populations with type 2 diabetes and improve their overall diabetes care.
Key Dates
- Start date
- Jul 24, 2023
- Status verified
- Jun 2025
- Primary completion
- Jul 31, 2026
- Completion
- Jul 31, 2026
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Continuous Glucose MonitoringParticipants will use a Freestyle Libre 2 monitoring device for 6 months to track blood glucose levels.
- Active Comparator: Traditional Glucometer ArmParticipants will use a traditional glucose monitoring device (glucometer) to self-monitor their blood glucose for 6 months to track blood glucose levels.
Primary Outcome Measure
Glycemic Control (Hemoglobin A1c) [ Time Frame: Baseline, 3 months, and 6 months. ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Nebraska Medicine | Omaha | Nebraska | 68198-7400D | - |
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