Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients

Not Applicable

• Conditions: Type 2 Diabetes

• Registration Number: NCT05766488
• Lead Sponsor: University of Nebraska

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 Timeline

• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-03-08
• Study First Posted: 2023-03-13
• Study Start: 2023-07-24
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-11
• Last Update Posted: 2025-06-15
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Glycemic Control (Hemoglobin A1c)	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 Outcome Measures

Name	Time	Method
Hypoglycemia	6 months	Continuous glucose monitor (CGM) and glucometer blood glucose data will be evaluated to determine number and percentage of hypoglycemic readings (i.e., \<70 mg/dL). For CGM data, % time within target range, % time below specific thresholds for hypoglycemia) will be captured and described.
Hyperglycemia	6 months	Continuous glucose monitor (CGM) and glucometer blood glucose data will be evaluated to determine percentage of hyperglycemic values (i.e., \>180 mg/dl) experienced. For CGM data, % time within target range, % time below specific thresholds for hypoglycemia) will be captured and described.
Blood Glucose Capture Rate	6 months	Number of days without any blood glucose recordings will be captured as a percentage over the study period.
Perceived or Experienced Benefits and Barriers to Device Use	Baseline and 6 months	A pre- and post-survey will be provided to all participants to qualitatively identify benefits and barriers to access and use of their assigned device and willingness to continue CGM use (follow-up survey).

Trial Locations

Locations (1)

Nebraska Medicine; 🇺🇸 Omaha, Nebraska, United States