Skip to main content
OpenTrials
Completed

NCT Number: NCT06643611

Addressing Disparities in Diabetes Care

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Myers Park Internal Medicine Clinic

Charlotte, North Carolina, 28207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Glucose Monitor

Behavioral

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

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.

Primary outcomes

  1. 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

  1. Appraisal of Diabetes Scale

    Time frame: Baseline, 1 Month Post Intervention

    Health-related quality of life will be measured using Appraisal of Diabetes scale (ADS). The ADS is a diabetes-specific quality of life instrument. It consists of 7 items on how diabetes affects the respondent. The score of each item ranges from 0 to 5 with 0 representing the least effect of diabetes and 5 the greatest effect of diabetes. The total score is calculated by summing the scores of individual items.

  2. Diabetes Treatment Satisfaction Questionnaire

    Time frame: Baseline, 1 Month Post Intervention

    Treatment satisfaction will be measured using the Diabetes Treatment Satisfaction Questionnaire (DTSQ). The DTSQ includes eight items on satisfaction with diabetes treatment, convenience, flexibility, understanding of diabetes, possibility of continuation of the current treatment and recommendation to others. Each item is scored on a scale from 0 to 6, with higher score indicating higher satisfaction.

  3. Change in Medication Adherence

    Time frame: 6 Months Post Intervention

    Medication adherence will be determined from prescription fill data and reported in the form of medication possession ratio (the sum of days of supply during a time period divided by the number of days in that time period). The change during six months before and after intervention start (time of assessment of study criteria for the control group) will be reported.

  4. Number of Hours Glucose Level in Normal Range

    Time frame: Week 1 and 2 of intervention, Last Two Weeks of Intervention

    Number of hours patient's glucose level is within normal range of 70-100.

  5. Number of Hours Glucose Level Above Normal Range

    Time frame: Week 1 and 2 of intervention, Last Two Weeks of Intervention

    Number of hours patient's glucose level is above normal range of 70-100.

  6. Number of Hours Glucose Level Below Normal Range

    Time frame: Week 1 and 2 of intervention, Last Two Weeks of Intervention

    Number of hours patient's glucose level is below normal range of 70-100.

  7. Average Glucose Level

    Time frame: Week 1 and 2 of intervention, Last Two Weeks of Intervention

    Average glucose level during the first two weeks of intervention. Normal range is 70-100 mg/dL. A low-level average indicates good glycemic control. A high level indicates uncontrolled diabetes.

  8. Glucose Management Indicator Percentage

    Time frame: Week 1 and 2 of intervention, Last Two Weeks of Intervention

    The glucose management indicator is an updated approach for estimating hemoglobin A1c from continuous glucose monitoring data. Range is 5.7%-14%.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • American Society of Health-System Pharmacists

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2024
Registry last updated
Nov 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.