Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients

University of Nebraska

Status: Invitation-only

Conditions: Type 2 Diabetes

Treatments: Device: Self-monitoring Blood Glucose (SMBG); Device: Continuous Glucose Monitor (CGM)

Study type: Interventional

Funder types: Other

Identifiers

NCT05766488

0314-22-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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
• Implanted medical device (e.g., pace-maker, defibrillator)
• Intellectual or physical disabilities that may interfere with ability to properly use the Continuous Glucose Monitor (CGM)
• Able to read English

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Continuous Glucose Monitoring

Experimental group

Description:

Participants will use a Freestyle Libre 2 monitoring device for 6 months to track blood glucose levels.

Treatment:

Device: Continuous Glucose Monitor (CGM)

Traditional Glucometer Arm

Active Comparator group

Description:

Participants will use a traditional glucose monitoring device (glucometer) to self-monitor their blood glucose for 6 months to track blood glucose levels.

Treatment:

Device: Self-monitoring Blood Glucose (SMBG)