Addressing Disparities in Diabetes Care

Addressing Disparities in Diabetes Care: Integrating Continuous Glucose Monitors and Pharmacist Medication Management for Uninsured Racial Minority Patients

The purpose of this research is to find out if using a continuous glucose monitor and working with a clinical pharmacist can help improve the health of uninsured minority patients with type 2 diabetes.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Continuous Glucose Monitor; Behavioral: Usual Care

Detailed Description

The objective of this research is to determine the effectiveness of a targeted intervention that integrates continuous glucose monitors and pharmacist-led comprehensive medication management services among uninsured adult patients with poor glycemic control on basal insulin, specifically focusing on Black and Hispanic populations. This pilot study is designed to help justify implementing this intervention on a larger scale within our healthcare system.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Atrium Health Myers Park Internal Medicine Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Hispanic or non-Hispanic Black
• Diagnosis of Type 2 diabetes
• HbA1c ≥8% within the past 3 months
• Active prescription for insulin and injecting at least 1 time daily

Exclusion Criteria:

• Gestational diabetes
• Type 1 diabetes
• Receiving care by endocrinologist
• Continuous glucose monitor use within the past 6 months
• Receiving long term, hospice, or palliative care services
• Malignant cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous Glucose Monitor; Patients in the intervention arm will receive a continuous glucose monitor in addition to usual care. These patients will be scheduled at least once monthly for clinical pharmacy visits.	Behavioral: Continuous Glucose Monitor; Patient will be provided a continuous glucose monitor. Pharmacist will provide information regarding how to best manage type 2 diabetes.
Active Comparator: Usual Care; Patients in the usual care arm will have routine physician office visits every 3 months if HbA1c outside goal or every 6 months if HbA1c within goal. Medication regimens will be managed by physicians, nurse practitioners, and physician assistants.	Behavioral: Usual Care; Routine physician office visits and hemoglobinA1c every 3 for those with HbA1c outside goal and every 6 months for those with HbA1c within goal. Medication regimens managed by physicians, nurse practitioners, and physician assistants. Patients are sent reminders on the phone prior to their visits or when they are due for a visit or any physical examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin A1c	Change in percentage for Hemoglobin A1c. Normal range for hemoglobin A1c is 4.2%-14%. A low level indicates no diabetes and a high level indicates uncontrolled diabetes.	Baseline to Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Medication Adherence	Medication adherence will be determined from prescription fill data and reported in the form of medication possession ratio (the sum of days of supply during a time period divided by the number of days in that time period). The change during six months before and after intervention start (time of assessment of study criteria for the control group) will be reported.	6 Months Post Intervention
Appraisal of Diabetes Scale	Health-related quality of life will be measured using Appraisal of Diabetes scale (ADS). The ADS is a diabetes-specific quality of life instrument. It consists of 7 items on how diabetes affects the respondent. The score of each item ranges from 0 to 5 with 0 representing the least effect of diabetes and 5 the greatest effect of diabetes. The total score is calculated by summing the scores of individual items.	Baseline, 1 Month Post Intervention
Diabetes Treatment Satisfaction Questionnaire	Treatment satisfaction will be measured using the Diabetes Treatment Satisfaction Questionnaire (DTSQ). The DTSQ includes eight items on satisfaction with diabetes treatment, convenience, flexibility, understanding of diabetes, possibility of continuation of the current treatment and recommendation to others. Each item is scored on a scale from 0 to 6, with higher score indicating higher satisfaction.	Baseline, 1 Month Post Intervention
Number of Hours Glucose Level in Normal Range	Number of hours patient's glucose level is within normal range of 70-100.	Week 1 and 2 of intervention, Last Two Weeks of Intervention
Number of Hours Glucose Level Above Normal Range	Number of hours patient's glucose level is above normal range of 70-100.	Week 1 and 2 of intervention, Last Two Weeks of Intervention
Number of Hours Glucose Level Below Normal Range	Number of hours patient's glucose level is below normal range of 70-100.	Week 1 and 2 of intervention, Last Two Weeks of Intervention
Average Glucose Level	Average glucose level during the first two weeks of intervention. Normal range is 70-100 mg/dL. A low-level average indicates good glycemic control. A high level indicates uncontrolled diabetes.	Week 1 and 2 of intervention, Last Two Weeks of Intervention
Glucose Management Indicator Percentage	The glucose management indicator is an updated approach for estimating hemoglobin A1c from continuous glucose monitoring data. Range is 5.7%-14%.	Week 1 and 2 of intervention, Last Two Weeks of Intervention

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: American Society of Health-System Pharmacists
• Investigators: Principal Investigator: Ryan Larson, PharmD, CPP, Myers Park Internal Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Actual): August 12, 2025
• Study Completion (Actual): September 22, 2025

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Estimated): November 3, 2025
• Last Update Submitted That Met QC Criteria: October 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: IRB00115753

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No