Addressing Disparities in Diabetes Care

NCT ID: NCT06643611

Last Updated: 2025-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-18

Study Completion Date

2025-09-22

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Continuous Glucose Monitor

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type 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.

Interventions

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Continuous Glucose Monitor

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Society of Health-System Pharmacists

OTHER

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ryan Larson, PharmD, CPP

Role: PRINCIPAL_INVESTIGATOR

Myers Park Internal Medicine

Locations

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Atrium Health Myers Park Internal Medicine Clinic

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB00115753

Identifier Type: -

Identifier Source: org_study_id

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