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Clinical Trials/NCT05766488
NCT05766488Enrolling By InvitationNot Applicable

Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients

University of Nebraska1 site in 1 country50 target enrollmentStarted: July 24, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
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

Experimental

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

Active Comparator

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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