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) — DEVICE
    A 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) — DEVICE
    A 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 Monitoring
    Participants will use a Freestyle Libre 2 monitoring device for 6 months to track blood glucose levels.
  • Active Comparator: Traditional Glucometer Arm
    Participants 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)

FacilityCityStateZIPSite coordinators
Nebraska MedicineOmahaNebraska68198-7400D-

Find similar trials in Omaha, NE

By condition

Related Studies