Addressing Disparities in Diabetes Care

NCT06643611 | Completed

• 1 other identifier: IRB00115753
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Appraisal of Diabetes Scale

  Baseline, 1 Month Post Intervention

• Diabetes Treatment Satisfaction Questionnaire

  Baseline, 1 Month Post Intervention

• Change in Medication Adherence

  6 Months Post Intervention

• Number of Hours Glucose Level in Normal Range

  Week 1 and 2 of intervention, Last Two Weeks of Intervention

• Number of Hours Glucose Level Above Normal Range

  Week 1 and 2 of intervention, Last Two Weeks of Intervention

Study Arms (2)

Continuous Glucose Monitor

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

Continuous Glucose Monitor BEHAVIORAL

Patient will be provided a continuous glucose monitor. Pharmacist will provide information regarding how to best manage type 2 diabetes.

Continuous Glucose Monitor

Usual Care BEHAVIORAL

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• American Society of Health-System Pharmacists: collaborator

Study Sites (1)

Atrium Health Myers Park Internal Medicine Clinic

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Ryan Larson, PharmD, CPP

  Myers Park Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 16, 2024
• Study Start: November 18, 2024
• Primary Completion: August 12, 2025
• Study Completion: September 22, 2025
• Last Updated: November 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)