Type 2 DiabetesNCT07195188
Game-Based Education and Treatment Adherence in Type 2 Diabetes
A study testing "Let's Learn Diabetes" Game-Based Education and Traditional Diabetes Education in people with Type 2 Diabetes and Diabete Mellitus, run by Izmir Tinaztepe University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn if an education program can help lower anxiety and improve treatment follow-up in adults with type 2 diabetes. The main questions it aims to answer are: Does attending the education program lower anxiety levels? Does it help people better follow their diabetes treatment… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Diabete Mellitus
- What is being tested?
- "Let's Learn Diabetes" Game-Based Education and Traditional Diabetes Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2024to 30 Nov 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Age at diagnosis of diabetes is recent or less than 1 year.
- Being on insulin therapy for more than three months.
- Mental or psychological comorbidity.
- Not within the target age range, under 40 years or over 65 years.
- Refusing to participate in the research.
- Not attending one or more of the four training sessions during the research process.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Game-based Education on Adherence to Treatment and Anxiety Level in Type 2 Diabetics Started on Insulin Therapy
The goal of this clinical trial is to learn if an education program can help lower anxiety and improve treatment follow-up in adults with type 2 diabetes. The main questions it aims to answer are:
Does attending the education program lower anxiety levels?
Read more
Does it help people better follow their diabetes treatment plan?
Researchers will compare two groups:
Education group: Participants who attend the program.
Control group: Participants who do not attend the program.
Participants will:
Be randomly assigned to either the education group or the control group.
Attend four weekly sessions, each lasting two hours, over one month (education group only).
Complete surveys before and after the program, including the Beck Anxiety Scale (to measure anxiety) and the Patient Compliance Scale for Type 2 Diabetes Mellitus Treatment (to measure treatment follow-up).
Read the detailed description
Study Type: This is a clinical trial that tests a diabetes education program. Number of Participants: A total of 72 people participated in the study
Group Assignment: Participants were randomly assigned to one of two groups:
Game-Based Education Group Traditional Education Group Study Model: Both groups were given diabetes education simultaneously, but through different methods Blinding: This was an open-label study in which both the researchers and the participants were aware of the type of education they received
Main Goal: To test whether a game-based education program can:
Improve how well people follow their diabetes treatment plan Lower anxiety levels in people recently starting insulin therapy Groups and Interventions
- Game-Based Education Group (Experimental Group) Intervention: "Let's Learn Diabetes" Board Game Description: Participants received diabetes education through an interactive, game-based program. The program consisted of four weekly sessions, each lasting two hours, over the course of one month The sessions involved group play to help participants: Improve their knowledge about diabetes Reduce anxiety related to diabetes care Follow their treatment plan more closely
- Traditional Education Group (Control Group) Intervention: Standard Diabetes Education via Lecture
Description:
Participants received standard education using lecture-style presentations. The schedule was the same as the game-based group: four weekly sessions, each two hours long.
Study Outcomes
Researchers measured two main outcomes before the study and one month after the last session:
Treatment Adherence How well participants followed their treatment plan. Measured using the Patient Compliance Scale for Type 2 Diabetes Mellitus Treatment (a survey that asks questions about treatment follow-up).
Anxiety Levels How anxious participants felt about their condition and treatment. Measured using the Beck Anxiety Scale (a survey that measures anxiety).
Who Could Join the Study
Participants were eligible if they:
Had a diagnosis of type 2 diabetes. Started insulin treatment within the past three months. Were 18 years or older. Could read and understand Turkish, since the program was in Turkish. Were willing to sign a consent form and take part in all study activities.
Participants were NOT eligible if they:
Had cognitive problems, severe psychiatric disorders, or dementia that would make participation difficult.
Had severe diabetes-related complications, such as diabetic ketoacidosis or advanced kidney failure.
Had completed a structured diabetes education program in the last six months. Had any other condition that researchers believed would make participation unsafe or inappropriate.
Timeline Study Start Date: April 2024 Final Data Collection Date: October 2024
Program Duration per Participant:
4 weeks total - one two-hour session each week. A follow-up check was done one month after the final session.
Location
The study was carried out at:
Uşak Training and Research Hospital, Diabetes Education Unit and Diabetes School, Uşak, Turkey.
- Conditions
- Type 2 Diabetes, Diabete Mellitus
- Being tested
- "Let's Learn Diabetes" Game-Based Education, Traditional Diabetes Education
- Keywords
- Type 2 Diabetes, Insulin Therapy, Game-Based Education, Treatment Adherence, Anxiety, Randomized Controlled Study, Nursing Education, Patient Education
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Treatment Adherence and Compliance, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Let's Learn Diabetes" Game-Based EducationBehavioural
Participants in the experimental group will receive diabetes education using the "Let's Learn Diabetes" board game. The program consists of four weekly sessions, each lasting two hours, over one month. The intervention is designed to improve diabetes knowledge, reduce anxiety, and enhance treatment adherence among patients with Type 2 Diabetes Mellitus on insulin therapy.
Traditional Diabetes EducationBehavioural
Participants in the control group will receive standard diabetes education through traditional lecture-based presentations. The education schedule matches the experimental group with four weekly sessions, each lasting two hours, over one month.
| Study group | Role | What they receive |
|---|---|---|
| Game-Based Education | Experimental | Arm Description:
Participants in this group will receive diabetes education using the "Let's Learn Diabetes" board game. The program consists of four weekly sessions, each lasting two hours, conducted over one month. The sessions aim to improve diabetes knowledge, reduce anxiety, and increase adherence to insulin therapy. Receives: Behavioral: "Let's Learn Diabetes" Game-Based Education |
| Traditional Diabetes Education | Active comparator | Participants in the control group will receive standard diabetes education through traditional lecture-based presentations. The education schedule matches the experimental group with four weekly sessions, each lasting two hours, over one month. Receives: Behavioral: Traditional Diabetes Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Compliance Levels
For Treatment Compliance: The level of compliance among individuals undergoing diabetes-to-diabetes treatment was determined using the Patient Compliance Scale for Type 2 Diabetes Treatment, a 30-item, five-point Likert-type scale. A low total score indicates high patient compliance.
For Anxiety: "Anxiety levels of individuals with diabetes were determined using the Beck Anxiety Scale (BAS), a 21-item, four-point Likert-type self-report scale. Higher scores indicate more severe anxiety.
Measured: Pre-intervention and Post-intervention (After 1 Month of Training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start5 Apr 2024
- Primary completion3 May 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Tinaztepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Usak State Hospital
- Responsible party
- Principal investigator, gönül düzgün, Izmir Tinaztepe University
- Investigators
- Gönül düzgün, phd, Study director, Izmir Tinaztepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195188
- Sponsor's protocol ID
- 352-352-10
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Erdem E, Duzgun G. The effect of game-based education on adherence to treatment and anxiety level in type 2 diabetics started on insulin therapy. PLoS One. 2026 Mar 30;21(3):e0345292. doi: 10.1371/journal.pone.0345292. eCollection 2026.
PubMed 41911162
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Game-based Education on Adherence to Treatment and Anxiety Level in Type 2 Diabetics Started on Insulin Therapy
- ClinicalTrials.gov ID
- NCT07195188
- Acronym / sponsor ID
- 352-352-10
- Conditions
- Type 2 Diabetes, Diabete Mellitus
- Keywords
- Type 2 Diabetes, Insulin Therapy, Game-Based Education, Treatment Adherence, Anxiety, Randomized Controlled Study, Nursing Education, Patient Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Izmir Tinaztepe UniversityUniversity, hospital or other
- Collaborators
- Usak State Hospital
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 26 Sep 2025 (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 goal of this clinical trial is to learn if an education program can help lower anxiety and improve treatment follow-up in adults with type 2 diabetes. The main questions it aims to answer are:
Does attending the education program lower anxiety levels?
Does it help people better follow their diabetes treatment plan?
Researchers will compare two groups:
Education group: Participants who attend the program.
Control group: Participants who do not attend the program.
Participants will:
Be randomly assigned to either the education group or the control group.
Attend four weekly sessions, each lasting two hours, over one month (education group only).
Complete surveys before and after the program, including the Beck Anxiety Scale (to measure anxiety) and the Patient Compliance Scale for Type 2 Diabetes Mellitus Treatment (to measure treatment follow-up).
Detailed description
Study Type: This is a clinical trial that tests a diabetes education program. Number of Participants: A total of 72 people participated in the study
Group Assignment: Participants were randomly assigned to one of two groups:
Game-Based Education Group Traditional Education Group Study Model: Both groups were given diabetes education simultaneously, but through different methods Blinding: This was an open-label study in which both the researchers and the participants were aware of the type of education they received
Main Goal: To test whether a game-based education program can:
Improve how well people follow their diabetes treatment plan Lower anxiety levels in people recently starting insulin therapy Groups and Interventions
- Game-Based Education Group (Experimental Group) Intervention: "Let's Learn Diabetes" Board Game Description: Participants received diabetes education through an interactive, game-based program. The program consisted of four weekly sessions, each lasting two hours, over the course of one month The sessions involved group play to help participants: Improve their knowledge about diabetes Reduce anxiety related to diabetes care Follow their treatment plan more closely
- Traditional Education Group (Control Group) Intervention: Standard Diabetes Education via Lecture
Description:
Participants received standard education using lecture-style presentations. The schedule was the same as the game-based group: four weekly sessions, each two hours long.
Study Outcomes
Researchers measured two main outcomes before the study and one month after the last session:
Treatment Adherence How well participants followed their treatment plan. Measured using the Patient Compliance Scale for Type 2 Diabetes Mellitus Treatment (a survey that asks questions about treatment follow-up).
Anxiety Levels How anxious participants felt about their condition and treatment. Measured using the Beck Anxiety Scale (a survey that measures anxiety).
Who Could Join the Study
Participants were eligible if they:
Had a diagnosis of type 2 diabetes. Started insulin treatment within the past three months. Were 18 years or older. Could read and understand Turkish, since the program was in Turkish. Were willing to sign a consent form and take part in all study activities.
Participants were NOT eligible if they:
Had cognitive problems, severe psychiatric disorders, or dementia that would make participation difficult.
Had severe diabetes-related complications, such as diabetic ketoacidosis or advanced kidney failure.
Had completed a structured diabetes education program in the last six months. Had any other condition that researchers believed would make participation unsafe or inappropriate.
Timeline Study Start Date: April 2024 Final Data Collection Date: October 2024
Program Duration per Participant:
4 weeks total - one two-hour session each week. A follow-up check was done one month after the final session.
Location
The study was carried out at:
Uşak Training and Research Hospital, Diabetes Education Unit and Diabetes School, Uşak, Turkey.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two groups
| Arm | Type | Receives |
|---|---|---|
| Game-Based Education | Experimental | Behavioral: "Let's Learn Diabetes" Game-Based EducationArm Description: Participants in this group will receive diabetes education using the "Let's Learn Diabetes" board game. The program consists of four weekly sessions, each lasting two hours, conducted over one month. The sessions aim to improve diabetes knowledge, reduce anxiety, and increase adherence to insulin therapy. |
| Traditional Diabetes Education | Active comparator | Behavioral: Traditional Diabetes EducationParticipants in the control group will receive standard diabetes education through traditional lecture-based presentations. The education schedule matches the experimental group with four weekly sessions, each lasting two hours, over one month. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Age at diagnosis of diabetes is recent or less than 1 year.
- Being on insulin therapy for more than three months.
- Mental or psychological comorbidity.
- Not within the target age range, under 40 years or over 65 years.
- Refusing to participate in the research.
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 |
|---|---|---|
| "Let's Learn Diabetes" Game-Based EducationParticipants in the experimental group will receive diabetes education using the "Let's Learn Diabetes" board game. The program consists of four weekly sessions, each lasting two hours, over one month. The intervention is designed to improve diabetes knowledge, reduce anxiety, and enhance treatment adherence among patients with Type 2 Diabetes Mellitus on insulin therapy. | Behavioural | Game-Based Education |
| Traditional Diabetes EducationParticipants in the control group will receive standard diabetes education through traditional lecture-based presentations. The education schedule matches the experimental group with four weekly sessions, each lasting two hours, over one month. | Behavioural | Traditional Diabetes Education |
Primary outcome
Treatment Compliance Levels
Time frame: Pre-intervention and Post-intervention (After 1 Month of Training)
For Treatment Compliance: The level of compliance among individuals undergoing diabetes-to-diabetes treatment was determined using the Patient Compliance Scale for Type 2 Diabetes Treatment, a 30-item, five-point Likert-type scale. A low total score indicates high patient compliance. For Anxiety: "Anxiety levels of individuals with diabetes were determined using the Beck Anxiety Scale (BAS), a 21-item, four-point Likert-type self-report scale. Higher scores indicate more severe anxiety.
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 26 Sep 2025.
- Derived from this study: PubMed 41911162Erdem E, Duzgun G. The effect of game-based education on adherence to treatment and anxiety level in type 2 diabetics started on insulin therapy. PLoS One. 2026 Mar 30;21(3):e0345292. doi: 10.1371/journal.pone.0345292. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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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.
Gönül düzgün, phd study director
Izmir Tinaztepe 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 "Let's Learn Diabetes" Game-Based Education and Traditional Diabetes Education in people with Type 2 Diabetes and Diabete Mellitus, run by Izmir Tinaztepe University at 1 site in Turkey (Türkiye).
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 0 inclusion and 6 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 26 Sep 2025. 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 Turkey (Türkiye). 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?
Treatment Compliance Levels (time frame: Pre-intervention and Post-intervention (After 1 Month of Training)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07195188, which also lists 1 linked publication.
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 26 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.