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Clinical Trials/NCT06643611
NCT06643611
Completed
N/A

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

Wake Forest University Health Sciences1 site in 1 country20 target enrollmentNovember 18, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
Wake Forest University Health Sciences
Enrollment
20
Locations
1
Primary Endpoint
Change in Hemoglobin A1c
Status
Completed
Last Updated
6 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 18, 2024
End Date
September 22, 2025
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Hemoglobin A1c

Time Frame: Baseline to Month 6

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.

Secondary Outcomes

  • 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)
  • Number of Hours Glucose Level Below Normal Range(Week 1 and 2 of intervention, Last Two Weeks of Intervention)
  • Average Glucose Level(Week 1 and 2 of intervention, Last Two Weeks of Intervention)
  • Glucose Management Indicator Percentage(Week 1 and 2 of intervention, Last Two Weeks of Intervention)

Study Sites (1)

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