Type 1 DiabetesNCT05923632
The Effect Of Model-Based Dıgıtal Game On Metabolıc Control, Self-Effıcıency And Qualıty Of Lıfe In Chıldren Wıth Type 1 Dıabetes
A study testing Dijital Game and Health Education in people with Type 1 Diabetes and Children, Only, run by Abant Izzet Baysal University at 2 sites in Turkey (Türkiye).
Trial summary
This study was planned to determine the effect of model-based digital game on metabolic control, self-efficacy and quality of life in children with T1DM. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Type 1 Diabetes, Children, Only
- What is being tested?
- Dijital Game and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Nov 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being in the 8-13 age range,
- Being diagnosed with T1DM at least 6 months ago,
- Ability to read and write Turkish,
- Ability to communicate verbally,
- To have Internet access,
- Computer, tablet, etc. to have and use technological tools,
- To volunteer to participate in the study
Who cannot join
- Having another chronic disease other than T1DM
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Bolu Abant İzzet Baysal Üniversitesi
Bolu
BEDRİYE AK, Associate Prof.Dr., +905327633151, bedriye_ak@yahoo.com
Özgür Bahadır, Lecturer, +905063589308, ozgursinanbahadir@hotmail.com
- Recruiting
Zonguldak Bülent Ecevit Üniversitesi
Zonguldak, 67600
Özgür Bahadır, Lecturer, +905063589308, ozgursinanbahadir@hotmail.com
ozgursinanbahadir@hotmail.com
About this study
This study was planned to determine the effect of model-based digital game on metabolic control, self-efficacy and quality of life in children with T1DM.
Read the detailed description
This study was planned to determine the effect of model-based digital game on metabolic control, self-efficacy and quality of life in children with T1DM. This study was planned as a randomized controlled trial with a pre-post test parallel group. Participants to be included in the study, In this study, children between the ages of 8-13 who were diagnosed with T1DM and followed up in the Pediatric Endocrinology outpatient clinics and services of two hospitals in two different centers will be selected. During the follow-up days of the children in the outpatient clinic, the diabetes nurse will be contacted to discuss working with the child with T1DM and their families. After the child and their parents are informed about the purpose and application of the study, that the collected data will only be used for scientific research purposes, the children and their families who gave their consent to participate in the study will be asked to sign the volunteering form. Children who agree to participate in the study will be given a password to log in to the created web page. Experimental and control groups will be determined according to the order of login with this password and randomization with https://www.randomizer.org/. Standard diabetes education was given to both groups before the game intervention to be applied to the experimental group; Children entering the site will be asked to fill in the Child with Type 1 Diabetes Descriptive Information Form, the Quality of Life in Children with Type 1 Diabetes Scale and the Diabetes Management Self-Efficacy Scale in Children with Type 1 Diabetes. After informing the children in the experimental group about the game designed based on The Information-Motivation-Behavioral Skills Model(IMB) of diabetes management on the website, it will be ensured that the children actively participate in the game for 9 weeks and their participation status in the background of the game will be followed; At the end of 9 weeks, all stages of the game will be required to be completed. Reminders will be made by contacting the children who have not completed the game in line with the follow-ups in the background, once a week. During this process, the control group; On a weekly basis, slides supported with visuals related to nutrition, exercise and drug use will be presented on the web page in the form of sessions. Children will be provided to watch each session. Whether the children complete the sessions or not will be monitored from the background. Children who do not complete the sessions will be reminded once a week.
All scales will be re-administered to both groups at the 12th week (3 weeks after the training). Scales will also be applied through the website. HbA1c and other blood levels of the parameters to be used in the study will be obtained from the hospital files at the beginning of the study and at the end of the 12th week, as they are routinely requested during the controls. At the end of the study, the control group will also be allowed to log in to the game via the website in terms of ethical compliance.
- Conditions
- Type 1 Diabetes, Children, Only
- Being tested
- Dijital Game and Health Education
- Keywords
- Type 1 Diabetes, Children, Digital Game, Metabolic Control, Self-efficacy, Life Quality
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dijital Game and Health EducationBehavioural
After the children in the experimental group are informed about the digital game designed according to The The Information-Motivation-Behavioral Skills Model (IMB) in diabetes management, active participation of the children in the digital game will be ensured for 9 weeks; and participation status will be followed in the background of the game. At the end of 9 weeks, children will be asked to complete all stages of the game. Children who do not complete the game will be contacted once a week in line with their background follow-up and reminders will be made.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients with type 1 diabetes | Experimental | By providing standard diabetes education before the digital game intervention, the child who enters the game will be asked to fill out the Child with Type 1 Diabetes Descriptive Information Form, the Quality of Life in Children with Type 1 Diabetes Scale, and the Diabetes Management Self-Efficacy Scale in Children with Type 1 Diabetes.After the children in the experimental group are informed about the digital game designed according to the Information-Motivation-Behavioral Skills Model (IIMB) in diabetes management, active participation of the children in the digital game will be ensured for 9 weeks, and participation status will be followed in the background of the game.At the end of 9 weeks, children will be asked to complete all stages of the game.Children who do not complete the game will be contacted once a week in line with the follow-up, and reminders will be made.At the 12th and 15th weeks (3 and 6 weeks after the training), all the scales will be administered again. Receives: Behavioral: Dijital Game and Health Education |
| Pediatric patients with type 1 diabetes receiving routine care | No intervention | At the beginning of the study, standard diabetes education will be given, and they will be asked to fill out the Children with Type 1 Diabetes Information Form, the Quality of Life Scale for Children with Type 1 Diabetes, and the Diabetes Management Self-Efficacy Scale. All scales will be administered again in the 12th and 15th weeks from the beginning of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Scale for Children with Type 1 Diabetes (PedsQL 3.0)
The scale was developed by Varni et al in 2003. It consists of five sub-dimensions: diabetes symptoms, treatment barriers, adherence to treatment, anxiety, and communication. The scale was prepared in a five-point Likert type, and the child form of the scale was designed for 5-7 age groups, 8-12 age groups and 13-18 age groups. A high total score from the scale indicates a high health-related quality of life. The internal consistency coefficient of the original form of the scale was 0.71(Varni et al,2003). The Turkish validity and reliability study of the 8-12 age form of the scale was performed by Ayar(2012), and the Turkish validity and reliability study of the 13-18 age form was performed by Çövener Özçelik et al(2015). In the study, the Cronbach's alpha values of the scales were 0.83 for 8-12 years old, 0.90 for 13-18 years old. In the studies of Ayar and Öztürk(2016); The internal consistency coefficient of the quality of life scale in children with diabetes was found to be 0.80.
Measured: 30 minutes
Secondary outcomes (1)
Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes
It is a scale developed by Moens(1998). In the scale prepared according to the fivepoint Likert system, 1= yes definitely, 2= maybe yes, 3=maybe yes, maybe no, 4=maybe no, 5 = of course no. The perceived self-efficacy score is calculated by dividing the total number of items, and there is a negative correlation between the increase in the total score and the level of self-efficacy. Medical treatment and nutrition (1-2-4-5-7-9-10-11-14-18-22-26); adjustment of nutrition and insulin dose (6-8-12-13-17-19-21-25); being able to tell about diabetes (23-24); it consists of four sub-dimensions, being honest with oneself and others(3-15-16-20). The total explanatory variance rate of the four-factor scale is 47.1%. The reliability coefficient of the original scale; It is 0.8.The Turkish validity and reliability study was done by Öztürk, Ayar and Bektas(2016). The total Cronbach's alpha coefficient of the Turkish scale is 0.85, and its sub-dimensions are 0.80, 0.75, 0.70 and 0.70, respectively.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start20 Nov 2024
- Primary completion20 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bedriye AK, Abant Izzet Baysal University
- Investigators
- Bedriye AK, Associate Prof.Dr., Study director, Abant Izzet Baysal UniversityÖzgür Bahadır, Lecturer, Principal investigator, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923632
- Sponsor's protocol ID
- AİBÜ-HEM-BA-01
- Status last verified
- Sep 2025
- First submitted
- 5 May 2023
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We wıll prepare the study as a thesıs. Then we wıll turn ıt ınto a publıcatıon ın an ınternatıonal magazıne.
Publications
Varni JW, Burwinkle TM, Jacobs JR, Gottschalk M, Kaufman F, Jones KL. The PedsQL in type 1 and type 2 diabetes: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales and type 1 Diabetes Module. Diabetes Care. 2003 Mar;26(3):631-7. doi: 10.2337/diacare.26.3.631.
PubMed 12610013Nansel TR, Weisberg-Benchell J, Wysocki T, Laffel L, Anderson B; Steering Committee of the Family Management of Diabetes Study. Quality of life in children with Type 1 diabetes: a comparison of general and diabetes-specific measures and support for a unitary diabetes quality-of-life construct. Diabet Med. 2008 Nov;25(11):1316-23. doi: 10.1111/j.1464-5491.2008.02574.x.
PubMed 19046222Christie D, Thompson R, Sawtell M, Allen E, Cairns J, Smith F, Jamieson E, Hargreaves K, Ingold A, Brooks L, Wiggins M, Oliver S, Jones R, Elbourne D, Santos A, Wong IC, O'Neill S, Strange V, Hindmarsh P, Annan F, Viner R. Structured, intensive education maximising engagement, motivation and long-term change for children and young people with diabetes: a cluster randomised controlled trial with integral process and economic evaluation - the CASCADE study. Health Technol Assess. 2014 Mar;18(20):1-202. doi: 10.3310/hta18200.
PubMed 24690402Brown SJ, Lieberman DA, Germeny BA, Fan YC, Wilson DM, Pasta DJ. Educational video game for juvenile diabetes: results of a controlled trial. Med Inform (Lond). 1997 Jan-Mar;22(1):77-89. doi: 10.3109/14639239709089835.
PubMed 9183781Gao J, Wang J, Zhu Y, Yu J. Validation of an information-motivation-behavioral skills model of self-care among Chinese adults with type 2 diabetes. BMC Public Health. 2013 Feb 4;13:100. doi: 10.1186/1471-2458-13-100.
PubMed 23379324Goncalves S, Barros V, Rui Gomes A. Eating-Disordered Behaviour in Adolescents with Type 1 Diabetes. Can J Diabetes. 2016 Apr;40(2):152-7. doi: 10.1016/j.jcjd.2015.09.011. Epub 2016 Feb 10.
PubMed 26874893Goyal S, Nunn CA, Rotondi M, Couperthwaite AB, Reiser S, Simone A, Katzman DK, Cafazzo JA, Palmert MR. A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial. JMIR Mhealth Uhealth. 2017 Jun 19;5(6):e82. doi: 10.2196/mhealth.7336.
PubMed 28630037Holtz BE, Murray KM, Hershey DD, Dunneback JK, Cotten SR, Holmstrom AJ, Vyas A, Kaiser MK, Wood MA. Developing a Patient-Centered mHealth App: A Tool for Adolescents With Type 1 Diabetes and Their Parents. JMIR Mhealth Uhealth. 2017 Apr 19;5(4):e53. doi: 10.2196/mhealth.6654.
PubMed 28428167Johnson D, Deterding S, Kuhn KA, Staneva A, Stoyanov S, Hides L. Gamification for health and wellbeing: A systematic review of the literature. Internet Interv. 2016 Nov 2;6:89-106. doi: 10.1016/j.invent.2016.10.002. eCollection 2016 Nov.
PubMed 30135818Martos-Cabrera MB, Membrive-Jimenez MJ, Suleiman-Martos N, Mota-Romero E, Canadas-De la Fuente GA, Gomez-Urquiza JL, Albendin-Garcia L. Games and Health Education for Diabetes Control: A Systematic Review with Meta-Analysis. Healthcare (Basel). 2020 Oct 14;8(4):399. doi: 10.3390/healthcare8040399.
PubMed 33066372Nelson LA, Wallston KA, Kripalani S, LeStourgeon LM, Williamson SE, Mayberry LS. Assessing barriers to diabetes medication adherence using the Information-Motivation-Behavioral skills model. Diabetes Res Clin Pract. 2018 Aug;142:374-384. doi: 10.1016/j.diabres.2018.05.046. Epub 2018 Jun 4.
PubMed 29879495
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Model-Based Dıgıtal Game On Metabolıc Control, Self-Effıcıency And Qualıty Of Lıfe In Chıldren Wıth Type 1 Dıabetes
- ClinicalTrials.gov ID
- NCT05923632
- Acronym / sponsor ID
- AİBÜ-HEM-BA-01
- Conditions
- Type 1 Diabetes, Children, Only
- Keywords
- Type 1 Diabetes, Children, Digital Game, Metabolic Control, Self-efficacy, Life Quality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 28 Jun 2023 (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.
This study was planned to determine the effect of model-based digital game on metabolic control, self-efficacy and quality of life in children with T1DM.
Detailed description
This study was planned to determine the effect of model-based digital game on metabolic control, self-efficacy and quality of life in children with T1DM. This study was planned as a randomized controlled trial with a pre-post test parallel group. Participants to be included in the study, In this study, children between the ages of 8-13 who were diagnosed with T1DM and followed up in the Pediatric Endocrinology outpatient clinics and services of two hospitals in two different centers will be selected. During the follow-up days of the children in the outpatient clinic, the diabetes nurse will be contacted to discuss working with the child with T1DM and their families. After the child and their parents are informed about the purpose and application of the study, that the collected data will only be used for scientific research purposes, the children and their families who gave their consent to participate in the study will be asked to sign the volunteering form. Children who agree to participate in the study will be given a password to log in to the created web page. Experimental and control groups will be determined according to the order of login with this password and randomization with https://www.randomizer.org/. Standard diabetes education was given to both groups before the game intervention to be applied to the experimental group; Children entering the site will be asked to fill in the Child with Type 1 Diabetes Descriptive Information Form, the Quality of Life in Children with Type 1 Diabetes Scale and the Diabetes Management Self-Efficacy Scale in Children with Type 1 Diabetes. After informing the children in the experimental group about the game designed based on The Information-Motivation-Behavioral Skills Model(IMB) of diabetes management on the website, it will be ensured that the children actively participate in the game for 9 weeks and their participation status in the background of the game will be followed; At the end of 9 weeks, all stages of the game will be required to be completed. Reminders will be made by contacting the children who have not completed the game in line with the follow-ups in the background, once a week. During this process, the control group; On a weekly basis, slides supported with visuals related to nutrition, exercise and drug use will be presented on the web page in the form of sessions. Children will be provided to watch each session. Whether the children complete the sessions or not will be monitored from the background. Children who do not complete the sessions will be reminded once a week.
All scales will be re-administered to both groups at the 12th week (3 weeks after the training). Scales will also be applied through the website. HbA1c and other blood levels of the parameters to be used in the study will be obtained from the hospital files at the beginning of the study and at the end of the 12th week, as they are routinely requested during the controls. At the end of the study, the control group will also be allowed to log in to the game via the website in terms of ethical compliance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients with type 1 diabetes | Experimental | Behavioral: Dijital Game and Health EducationBy providing standard diabetes education before the digital game intervention, the child who enters the game will be asked to fill out the Child with Type 1 Diabetes Descriptive Information Form, the Quality of Life in Children with Type 1 Diabetes Scale, and the Diabetes Management Self-Efficacy Scale in Children with Type 1 Diabetes.After the children in the experimental group are informed about the digital game designed according to the Information-Motivation-Behavioral Skills Model (IIMB) in diabetes management, active participation of the children in the digital game will be ensured for 9 weeks, and participation status will be followed in the background of the game.At the end of 9 weeks, children will be asked to complete all stages of the game.Children who do not complete the game will be contacted once a week in line with the follow-up, and reminders will be made.At the 12th and 15th weeks (3 and 6 weeks after the training), all the scales will be administered again. |
| Pediatric patients with type 1 diabetes receiving routine care | No intervention | –At the beginning of the study, standard diabetes education will be given, and they will be asked to fill out the Children with Type 1 Diabetes Information Form, the Quality of Life Scale for Children with Type 1 Diabetes, and the Diabetes Management Self-Efficacy Scale. All scales will be administered again in the 12th and 15th weeks from the beginning of the study. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Being in the 8-13 age range,
- Being diagnosed with T1DM at least 6 months ago,
- Ability to read and write Turkish,
- Ability to communicate verbally,
- To have Internet access,
Key exclusion criteria (1 listed)
- Having another chronic disease other than T1DM
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 |
|---|---|---|
| Dijital Game and Health EducationAfter the children in the experimental group are informed about the digital game designed according to The The Information-Motivation-Behavioral Skills Model (IMB) in diabetes management, active participation of the children in the digital game will be ensured for 9 weeks; and participation status will be followed in the background of the game. At the end of 9 weeks, children will be asked to complete all stages of the game. Children who do not complete the game will be contacted once a week in line with their background follow-up and reminders will be made. | Behavioural | Pediatric patients with type 1 diabetes |
Primary outcome
Quality of Life Scale for Children with Type 1 Diabetes (PedsQL 3.0)
Time frame: 30 minutes
The scale was developed by Varni et al in 2003. It consists of five sub-dimensions: diabetes symptoms, treatment barriers, adherence to treatment, anxiety, and communication. The scale was prepared in a five-point Likert type, and the child form of the scale was designed for 5-7 age groups, 8-12 age groups and 13-18 age groups. A high total score from the scale indicates a high health-related quality of life. The internal consistency coefficient of the original form of the scale was 0.71(Varni et al,2003). The Turkish validity and reliability study of the 8-12 age form of the scale was performed by Ayar(2012), and the Turkish validity and reliability study of the 13-18 age form was performed by Çövener Özçelik et al(2015). In the study, the Cronbach's alpha values of the scales were 0.83 for 8-12 years old, 0.90 for 13-18 years old. In the studies of Ayar and Öztürk(2016); The internal consistency coefficient of the quality of life scale in children with diabetes was found to be 0.80.
1 secondary outcome
Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Background: PubMed 12610013Varni JW, Burwinkle TM, Jacobs JR, Gottschalk M, Kaufman F, Jones KL. The PedsQL in type 1 and type 2 diabetes: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales and type 1 Diabetes Module. Diabetes Care. 2003 Mar;26(3):631-7. doi: 10.2337/diacare.26.3.631.
- Background: PubMed 19046222Nansel TR, Weisberg-Benchell J, Wysocki T, Laffel L, Anderson B; Steering Committee of the Family Management of Diabetes Study. Quality of life in children with Type 1 diabetes: a comparison of general and diabetes-specific measures and support for a unitary diabetes quality-of-life construct. Diabet Med. 2008 Nov;25(11):1316-23. doi: 10.1111/j.1464-5491.2008.02574.x.
- Background: PubMed 24690402Christie D, Thompson R, Sawtell M, Allen E, Cairns J, Smith F, Jamieson E, Hargreaves K, Ingold A, Brooks L, Wiggins M, Oliver S, Jones R, Elbourne D, Santos A, Wong IC, O'Neill S, Strange V, Hindmarsh P, Annan F, Viner R. Structured, intensive education maximising engagement, motivation and long-term change for children and young people with diabetes: a cluster randomised controlled trial with integral process and economic evaluation - the CASCADE study. Health Technol Assess. 2014 Mar;18(20):1-202. doi: 10.3310/hta18200.
- Background: PubMed 9183781Brown SJ, Lieberman DA, Germeny BA, Fan YC, Wilson DM, Pasta DJ. Educational video game for juvenile diabetes: results of a controlled trial. Med Inform (Lond). 1997 Jan-Mar;22(1):77-89. doi: 10.3109/14639239709089835.
- Background: PubMed 23379324Gao J, Wang J, Zhu Y, Yu J. Validation of an information-motivation-behavioral skills model of self-care among Chinese adults with type 2 diabetes. BMC Public Health. 2013 Feb 4;13:100. doi: 10.1186/1471-2458-13-100.
- Background: PubMed 26874893Goncalves S, Barros V, Rui Gomes A. Eating-Disordered Behaviour in Adolescents with Type 1 Diabetes. Can J Diabetes. 2016 Apr;40(2):152-7. doi: 10.1016/j.jcjd.2015.09.011. Epub 2016 Feb 10.
- Background: PubMed 28630037Goyal S, Nunn CA, Rotondi M, Couperthwaite AB, Reiser S, Simone A, Katzman DK, Cafazzo JA, Palmert MR. A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial. JMIR Mhealth Uhealth. 2017 Jun 19;5(6):e82. doi: 10.2196/mhealth.7336.
- Background: PubMed 28428167Holtz BE, Murray KM, Hershey DD, Dunneback JK, Cotten SR, Holmstrom AJ, Vyas A, Kaiser MK, Wood MA. Developing a Patient-Centered mHealth App: A Tool for Adolescents With Type 1 Diabetes and Their Parents. JMIR Mhealth Uhealth. 2017 Apr 19;5(4):e53. doi: 10.2196/mhealth.6654.
- Background: PubMed 30135818Johnson D, Deterding S, Kuhn KA, Staneva A, Stoyanov S, Hides L. Gamification for health and wellbeing: A systematic review of the literature. Internet Interv. 2016 Nov 2;6:89-106. doi: 10.1016/j.invent.2016.10.002. eCollection 2016 Nov.
- Background: PubMed 33066372Martos-Cabrera MB, Membrive-Jimenez MJ, Suleiman-Martos N, Mota-Romero E, Canadas-De la Fuente GA, Gomez-Urquiza JL, Albendin-Garcia L. Games and Health Education for Diabetes Control: A Systematic Review with Meta-Analysis. Healthcare (Basel). 2020 Oct 14;8(4):399. doi: 10.3390/healthcare8040399.
- Background: PubMed 29879495Nelson LA, Wallston KA, Kripalani S, LeStourgeon LM, Williamson SE, Mayberry LS. Assessing barriers to diabetes medication adherence using the Information-Motivation-Behavioral skills model. Diabetes Res Clin Pract. 2018 Aug;142:374-384. doi: 10.1016/j.diabres.2018.05.046. Epub 2018 Jun 4.
- Individual participant dataSharing planned: Yes. We wıll prepare the study as a thesıs. Then we wıll turn ıt ınto a publıcatıon ın an ınternatıonal magazıne.
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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.
Bedriye AK, Associate Prof.Dr. study director
Abant Izzet Baysal University
Özgür Bahadır, Lecturer principal investigator
Zonguldak Bulent Ecevit University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dijital Game and Health Education in people with Type 1 Diabetes and Children, Only, run by Abant Izzet Baysal University at 2 sites 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 7 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 11 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 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bedriye AK, Associate Prof.Dr. (+905327633151, bedriye_ak@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life Scale for Children with Type 1 Diabetes (PedsQL 3.0) (time frame: 30 minutes). 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 NCT05923632, which also lists 11 linked publications.
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 11 Sep 2025.