DiabetesNCT06695533
I Can Do This! Managing My Diabetes
A study testing Diabetes self management workbook in people with Diabetes, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Diabetes self management workbook
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2025to 12 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Focus group inclusion:
- 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
- Focus group exclusion:
Show all 19Show fewer
- Cannot speak/read English
- Unwilling to participate in group discussion
- Pregnancy
- Aim 2 inclusion criteria:
- 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)
- Aim 2 exclusion criteria:
- Cannot speak/read English
- Unwilling to return for a follow-up visit in 3 months
- Pregnancy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "I Can Do This! Managing My Diabetes: A Pilot Project Using a Novel Word Game-based Workbook Intervention to Allow People Living With Diabetes to Increase Their Diabetes Self-efficacy"
The goals of this study are to:
- 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.
- Assess the feasibility and acceptability of the workbook.
- Understand the implementation challenges that will be important for improving the workbook and preparing it for larger-scale effectiveness research.
Read more
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.
Read the 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
- Being tested
- Diabetes self management workbook
- Keywords
- Diabetes self-management, Patient education, Glycemic control
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes self management workbookBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes self management | Experimental | Eligible participants will utilize the workbook for a span of 3 months Receives: Behavioral: Diabetes self management workbook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes self-efficacy score (Diabetes management self-efficacy (DMSE)
Measures the confidence of patients with diabetes regarding diet, exercise and medical treatment)
Measured: 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.
Measured: 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
Measured: 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.
Measured: Pre test, post test (3months)
Secondary outcomes (3)
Change in Hemoglobin A1c
HbA1c, or glycated hemoglobin, measures average blood glucose levels over the past two to three months. It's expressed as a percentage, with higher values indicating poorer blood sugar control
Measured: Pre test, post test (3months)
Change in Weight
Change in Weight over the course of study.
Measured: Pre test, post test (3months)
Change in Blood Pressure
Change in Blood Pressure over the course of study.
Measured: Pre test, post test (3months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start21 Aug 2025
- Primary completion12 Feb 2026
- Study completion12 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Center for Diabetes Translation Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Catherine Park, Emory University
- Investigators
- Catherine Park, MD, Principal investigator, Emory UniversitySaria Hassan, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695533
- Sponsor's protocol ID
- STUDY00008292
- Other IDs
- 2025P011698, P30DK111024
- Status last verified
- Feb 2026
- First submitted
- 16 Nov 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "I Can Do This! Managing My Diabetes: A Pilot Project Using a Novel Word Game-based Workbook Intervention to Allow People Living With Diabetes to Increase Their Diabetes Self-efficacy"
- ClinicalTrials.gov ID
- NCT06695533
- Acronym / sponsor ID
- STUDY00008292
- Conditions
- Diabetes
- Keywords
- Diabetes self-management, Patient education, Glycemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Georgia Center for Diabetes Translation Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goals of this study are to:
- 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.
- Assess the feasibility and acceptability of the workbook.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Diabetes self management | Experimental | Behavioral: Diabetes self management workbookEligible participants will utilize the workbook for a span of 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
- Cannot speak/read English
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes self management workbookThe 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. | Behavioural | Diabetes self management |
Primary outcome
Diabetes self-efficacy score (Diabetes management self-efficacy (DMSE)
Time frame: Pre test, post test (3months)
Measures the confidence of patients with diabetes regarding diet, exercise and medical treatment)
Knowledge of American Diabetes Association (ADA) diabetes plate method
Time frame: Pre test, post test (3months)
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.
Acceptability of Intervention Measure (AIM)
Time frame: Pre test, post test (3months)
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
Feasibility of Intervention Measure (FIM)
Time frame: Pre test, post test (3months)
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.
3 secondary outcomes
Change in Hemoglobin A1c
Time frame: Pre test, post test (3months)
Change in Weight
Time frame: Pre test, post test (3months)
Change in Blood Pressure
Time frame: Pre test, post test (3months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Park, MD principal investigator
Emory University
Saria Hassan, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes self management workbook in people with Diabetes, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes self-efficacy score (Diabetes management self-efficacy (DMSE) (time frame: Pre test, post test (3months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.