I Can Do This! Managing My Diabetes

NCT ID: NCT06695533

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-21
• Study Completion Date: 2026-01-31

Brief 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.

Detailed 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.

Conditions

Diabetes

Keywords

Diabetes self-management; Patient education; Glycemic control

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Diabetes self management

Eligible participants will utilize the workbook for a span of 3 months

Group Type: EXPERIMENTAL

Diabetes self management workbook

Intervention Type: BEHAVIORAL

The diabetes self-management workbook section used in this pilot study will focus on diet management, specifically carbohydrates, following ADA guidelines. It will include exercises based on the ADA diabetes plate method, aimed at helping subjects understand meal planning, food categories, portion sizes, goal setting, and the impact of foods on blood glucose levels. Activities will include word searches, crosswords, and goal-setting exercises. Subjects will begin the first section during a clinic visit. They can complete the workbook at home over three months, with input from subjects and Certified Diabetes Care and Education Specialists to refine the content.

Interventions

Diabetes self management workbook

The diabetes self-management workbook section used in this pilot study will focus on diet management, specifically carbohydrates, following ADA guidelines. It will include exercises based on the ADA diabetes plate method, aimed at helping subjects understand meal planning, food categories, portion sizes, goal setting, and the impact of foods on blood glucose levels. Activities will include word searches, crosswords, and goal-setting exercises. Subjects will begin the first section during a clinic visit. They can complete the workbook at home over three months, with input from subjects and Certified Diabetes Care and Education Specialists to refine the content.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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 for patients with diabetes

4. Diabetes educators: diabetes educator

Focus group exclusion:

1. Cannot speak/read English

2. Unwilling to participate in group discussion

3. Pregnancy

1. Having type 2 diabetes which is not insulin dependent since insulin management adds another 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 readings within the 2 years before the recruitment phase of the study. The ADA recommends the initiation of insulin therapy for individuals with a hemoglobin a1c above 10%, therefore the study will focus on an intervention for diabetes before insulin is likely to be part of the management plan.

3. Not having any conditions that could interfere with the accuracy of a hemoglobin a1c result: 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 3 on the Mini-Cog test scale which would represent a lower likelihood of dementia, and the ability to drive to medical visits.

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

Exclusion Criteria

1. Cannot speak/read English

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

3. Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Georgia Center for Diabetes Translation Research

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Catherine Park

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catherine Park, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Saria Hassan, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Midtown Clinic

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

2025P011698

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00008292

Identifier Type: -

Identifier Source: org_study_id