Clinical trial NCT05766488: Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients
Official title: Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Great Plains IDeA-CTR
First posted: 2023-03-13
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to one of two groups and receive either the treatment intervention, continuous glucose monitor (CGM), or standard of care intervention ,traditional glucometer, upon enrollment.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Glycemic Control (Hemoglobin A1c)
timeFrame: Baseline, 3 months, and 6 months.
Secondary outcomes:
measure: Hypoglycemia
timeFrame: 6 months
measure: Hyperglycemia
timeFrame: 6 months
measure: Blood Glucose Capture Rate
timeFrame: 6 months
measure: Perceived or Experienced Benefits and Barriers to Device Use
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Nebraska Medicine
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Drew C Prescott, PharmD
role: PRINCIPAL_INVESTIGATOR
References: