Assessing Continuous Glucose Monitor Use in Underserved Primary Care Patients

NCT05766488 | Enrolling By Invitation FDA Device

• 1 other identifier: 0314-22-FB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Glycemic Control (Hemoglobin A1c)

  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.

  Baseline, 3 months, and 6 months.

Secondary Outcomes (4)

• Hypoglycemia

  6 months

• Hyperglycemia

  6 months

• Blood Glucose Capture Rate

  6 months

• Perceived or Experienced Benefits and Barriers to Device Use

  Baseline and 6 months

Study Arms (2)

Continuous Glucose Monitoring

EXPERIMENTAL

Participants will use a Freestyle Libre 2 monitoring device for 6 months to track blood glucose levels.

Device: Continuous Glucose Monitor (CGM)

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.

Device: Self-monitoring Blood Glucose (SMBG)

Interventions

Continuous Glucose Monitor (CGM) DEVICE

A Freestyle Libre 2 continuous glucose monitor (CGM) will be provided in the experimental arm of this study for 6 months.

Also known as: Flash-glucose Monitor

Continuous Glucose Monitoring

Self-monitoring Blood Glucose (SMBG) DEVICE

A traditional glucometer device will be assigned in the active comparitor arm of this study for 6 months.

Also known as: Traditional glucometer

Traditional Glucometer Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes
• A1c \>9% at recruitment
• On/initiating insulin or on two or more diabetes medications

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• Great Plains IDeA-CTR: collaborator

Study Sites (1)

Nebraska Medicine

Omaha, Nebraska, 68198-7400D, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Officials

• Drew C Prescott, PharmD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 13, 2023
• Study Start: July 24, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)