Addressing Disparities in Diabetes Care

Wake Forest University (WFU)

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Usual Care; Behavioral: Continuous Glucose Monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT06643611

IRB00115753

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Continuous Glucose Monitor

Experimental group

Description:

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.

Treatment:

Behavioral: Continuous Glucose Monitor

Usual Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Usual Care