Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- University of Nebraska
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Glycemic Control (Hemoglobin A1c)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
Continuous Glucose Monitoring
Participants will use a Freestyle Libre 2 monitoring device for 6 months to track blood glucose levels.
Intervention: Continuous Glucose Monitor (CGM) (Device)
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.
Intervention: Self-monitoring Blood Glucose (SMBG) (Device)
Outcomes
Primary Outcomes
Glycemic Control (Hemoglobin A1c)
Time Frame: Baseline, 3 months, and 6 months.
Glycemic control will be assessed by measuring hemoglobin A1c at baseline, 3 months, and 6 months. Values will be evaluated as a continuous variable and categorized as \<7.0% vs \>7.0% to \<9.0% and \>9.0%. Comparisons of the proportions of participants achieving a minimum of 1 point drop in hemoglobin A1c will be made between study arms.
Secondary Outcomes
- Hyperglycemia(6 months)
- Blood Glucose Capture Rate(6 months)
- Perceived or Experienced Benefits and Barriers to Device Use(Baseline and 6 months)
- Hypoglycemia(6 months)
