I Can Do This! Managing My Diabetes

Last updated: February 26, 2025
Sponsor: Emory University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetic Neuropathy

Diabetic Macular Edema

Diabetic Foot Ulcers

Treatment

Diabetes self management workbook

Clinical Study ID

NCT06695533
STUDY00008292
  • Ages > 18
  • All Genders

Study Summary

The goals of this study are to:

  1. Co-develop a user-friendly word game-based workbook format for patients with diabetes to understand how to manage their diabetes. For this study, the first section of the workbook will be developed to teach carbohydrate management.

  2. Assess the feasibility and acceptability of the workbook.

  3. Understand the implementation challenges that will be important for improving the workbook and preparing it for larger-scale effectiveness research.

Participants will be asked to:

  • Complete the workbook during their waiting time in the clinic or at home.

  • Engage in word games designed to teach diabetes management vocabulary and concepts.

  • Attend follow-up sessions to assess changes in self-efficacy and glycemic control.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Focus group inclusion:

  1. Patients: adult with diabetes and patient at the Midtown Clinic

  2. Caregivers: partner, or caregiver of a patient with diabetes

  3. Providers: Physician Assistant (PA), Nurse Practitioner (NP), or MD who cares forpatients with diabetes

  4. Diabetes educators: diabetes educator

Focus group exclusion:

  1. Cannot speak/read English

  2. Unwilling to participate in group discussion

  3. Pregnancy

Aim 2 inclusion criteria:

  1. Having type 2 diabetes which is not insulin dependent since insulin management addsanother level of diabetes self-management that would confound self-efficacy scores.

  2. Having a hemoglobin a1c less than 10% based on their last 3 hemoglobin a1c readingswithin the 2 years before the recruitment phase of the study. The ADA recommends theinitiation of insulin therapy for individuals with a hemoglobin a1c above 10%,therefore the study will focus on an intervention for diabetes before insulin islikely to be part of the management plan.

  3. Not having any conditions that could interfere with the accuracy of a hemoglobin a1cresult: anemia, hemoglobinopathy, end-stage renal disease, chronic liver disease.

  4. The ability to read a passage set at a fifth-grade literacy, a score of at least 3on the Mini-Cog test scale which would represent a lower likelihood of dementia, andthe ability to drive to medical visits.

  5. Subjects will represent a diversity of age, educational level, and socioeconomicstatus (will use type of medical insurance as a proxy)

Exclusion

Aim 2 exclusion criteria:

  1. Cannot speak/read English

  2. Unwilling to return for a follow-up visit in 3 months

  3. Pregnancy

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Diabetes self management workbook
Phase:
Study Start date:
June 01, 2025
Estimated Completion Date:
January 31, 2026

Study Description

Diabetes poses a significant public health challenge in the U.S., affecting approximately 37 million people, or 11% of the population. The prevalence is rising, particularly among youth, with a forecasted 700% increase in type 2 diabetes cases by 2060. Diabetes leads to severe health complications, including increased risks of heart attacks, strokes, and kidney failure, and affects nearly 1 million people worldwide with vision loss. Many individuals struggle to manage their diabetes effectively; only about 50% achieve proper glycemic control.

Diabetes self-management education is crucial for improving self-efficacy and adherence to treatment, yet only 5-7% of eligible patients receive this education. The American Diabetes Association advocates for individualized nutrition therapy, but access remains limited, especially for uninsured populations, exacerbating health disparities.

To address this gap, a novel word game-based workbook is proposed to enhance diabetes self-efficacy. This workbook can be used in waiting rooms or at home, offering an engaging way to learn about diabetes management through word games and puzzles. It aims to provide accessible education for underserved communities, improve glycemic control, and ultimately reduce diabetes-related disparities.

Connect with a study center

  • Emory Midtown Clinic

    Atlanta, Georgia 30329
    United States

    Active - Recruiting

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