NCT05766488

Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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. This study will evaluate the perceived and experienced benefits and barriers of continuous glucose monitor (CGM) and traditional glucometer use and identify diabetes related outcomes associated with CGM use relative to usual care with self-monitoring of blood glucose (SMBG) in an underserved population. Eligible adult (\>=19 years of age) patients at participating clinics with type 2 diabetes, A1c \>=9%, and concomitant insulin therapy and/or using two or more diabetes medications will be randomly enrolled to one of two groups: Freestyle Libre 2 CGM or traditional glucometer. Pre- and post-surveys will be used to evaluate perceived and experienced benefits and barriers to CGM use and diabetes-related outcomes will be compared between the groups using face-to-face, telephonic, and/or digital avenues. The latter aim will replicate current processes of team-based diabetes care which is blood glucose management from a pharmacist under collaborative practice with the primary care physician. Follow-up will also replicate these clinic processes throughout the 6-month period, including telephone calls and monthly in-clinic visits.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DEVICE	Continuous Glucose Monitor (CGM)	A Freestyle Libre 2 continuous glucose monitor (CGM) will be provided in the experimental arm of this study for 6 months.
DEVICE	Self-monitoring Blood Glucose (SMBG)	A traditional glucometer device will be assigned in the active comparitor arm of this study for 6 months.

Timeline

• Start date: 2023-07-24
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2023-03-13
• Last updated: 2025-09-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study