Clinical trial NCT06643611: Addressing Disparities in Diabetes Care
Official title: Addressing Disparities in Diabetes Care: Integrating CGMs and Pharmacist Medication Management for Uninsured Racial Minority Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: American Society of Health System
First posted: 2024-10-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Hemoglobin A1c
timeFrame: Baseline to Month 6
Secondary outcomes:
measure: Health-Related Quality of Life
timeFrame: Baseline
measure: Health-Related Quality of Life
timeFrame: 1 Month Post Intervention
measure: Treatment Satisfaction
timeFrame: Baseline
measure: Treatment Satisfaction
timeFrame: 1 Month Post Intervention
measure: Change in Medication Adherence
timeFrame: 6 Months Post Intervention
measure: Number of Hours Glucose Level in Normal Range
timeFrame: First Two Weeks of Intervention
measure: Number of Hours Glucose Level in Normal Range
timeFrame: Last Two Weeks of Intervention
measure: Number of Hours Glucose Level Above Normal Range
timeFrame: First Two Weeks of Intervention
measure: Number of Hours Glucose Level Above Normal Range
timeFrame: Last Two Weeks of Intervention
measure: Number of Hours Glucose Level Below Normal Range
timeFrame: First Two Weeks of Intervention
measure: Number of Hours Glucose Level Below Normal Range
timeFrame: Last Two Weeks of Intervention
measure: Average Glucose Level
timeFrame: First Two Weeks of Intervention
measure: Average Glucose Level
timeFrame: Last Two Weeks of Intervention
measure: Glucose Management Indicator Percentage
timeFrame: First Two Weeks of Intervention
measure: Glucose Management Indicator Percentage
timeFrame: Last Two Weeks of Intervention
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium Health Myers Park Internal Medicine Clinic
state: North Carolina
Study officials:
affiliation: Myers Park Internal Medicine
name: Ryan Larson, PharmD, CPP
role: PRINCIPAL_INVESTIGATOR
References: