Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients

Overview

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.

Interventions

• 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.

Primary outcome measures

• Glycemic Control (Hemoglobin A1c) [Time frame: Baseline, 3 months, and 6 months.]

Secondary outcome measures (4)

• Hypoglycemia [Time frame: 6 months]
• Hyperglycemia [Time frame: 6 months]
• Blood Glucose Capture Rate [Time frame: 6 months]
• Perceived or Experienced Benefits and Barriers to Device Use [Time frame: Baseline and 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Nebraska Medicine — Omaha

Identifiers

NCT: NCT05766488 · 0314-22-FB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗