I Can Do This! Managing My Diabetes

NCT06695533 | Completed

• 2 other identifiers: STUDY000082922025P011698
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The goals of this study are 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.

Conditions

Diabetes

Keywords

Diabetes self-management; Patient education; Glycemic control

Outcome Measures

Primary Outcomes (4)

• Diabetes self-efficacy score (Diabetes management self-efficacy (DMSE)

  Measures the confidence of patients with diabetes regarding diet, exercise and medical treatment)

  Pre test, post test (3months)

• Knowledge of American Diabetes Association (ADA) diabetes plate method

  The ADA diabetes plate method is a meal planning tool that divides a plate into three sections: half for non-starchy vegetables, one-quarter for lean protein, and one-quarter for whole grains or starchy foods. It helps individuals with diabetes control portions and manage carbohydrate intake for better blood glucose control.

  Pre test, post test (3months)

• Acceptability of Intervention Measure (AIM)

  The Acceptability of Intervention Measure (AIM) is a tool used to assess how acceptable an intervention is to participants. The AIM is a 4-item instrument that uses a 5-point Likert scale

  Pre test, post test (3months)

• Feasibility of Intervention Measure (FIM)

  The Feasibility of Intervention Measure (FIM) is a tool used to assess the perceived feasibility of an intervention. The FIM is a 4-item instrument that uses a 5-point Likert scale.

  Pre test, post test (3months)

Secondary Outcomes (3)

• Change in Hemoglobin A1c

  Pre test, post test (3months)

• Change in Weight

  Pre test, post test (3months)

• Change in Blood Pressure

  Pre test, post test (3months)

Study Arms (1)

Diabetes self management

EXPERIMENTAL

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

Behavioral: Diabetes self management workbook

Interventions

Diabetes self management workbook 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.

Diabetes self management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients: adult with diabetes and patient at the Midtown Clinic
• Caregivers: partner, or caregiver of a patient with diabetes
• Providers: Physician Assistant (PA), Nurse Practitioner (NP), or MD who cares for patients with diabetes
• Diabetes educators: diabetes educator

You may not qualify if:

• Cannot speak/read English
• Unwilling to participate in group discussion
• Pregnancy
• 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.
• 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.
• Not having any conditions that could interfere with the accuracy of a hemoglobin a1c result: anemia, hemoglobinopathy, end-stage renal disease, chronic liver disease.
• 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.
• Subjects will represent a diversity of age, educational level, and socioeconomic status (will use type of medical insurance as a proxy)
• Cannot speak/read English
• Unwilling to return for a follow-up visit in 3 months
• Pregnancy

Sponsors & Collaborators

• Emory University: lead
• Georgia Center for Diabetes Translation Research: collaborator

Study Sites (1)

Emory Midtown Clinic

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Catherine Park, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Saria Hassan, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The workbook will be designed with the help of 5 focus group discussions. Five focus groups will include participants from one of the following categories: patients, caregivers, providers, and diabetes educators. Each focus group will have 6-10 participants.

Study Record Dates

• First Submitted: November 16, 2024
• First Posted: November 19, 2024
• Study Start: August 21, 2025
• Primary Completion: February 12, 2026
• Study Completion: February 12, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-02

Locations

US (1)