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Type 1 Diabetes MellitusNCT07409701

Gamification Intervertion in Children With Type 1 Diabetes

A study testing Gamification in people with Type 1 Diabetes Mellitus, run by KTO Karatay University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Objective: This study aims to examine the effect of education provided through gamification methods on health literacy and quality of life in children diagnosed with type 1 diabetes (T1DM). Materials and Methods: The study is planned as a randomized controlled trial with a pre-test-post-test, parallel design (1:1). Read more about this study

Who is it for?
Ages 8 to 12 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Gamification
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Jan 2026to 30 Apr 2027
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 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Diagnosed with type 1 diabetes
  • Aged between 8 and 12 years
  • Diagnosed with type 1 diabetes for at least 1 year and having received standard diabetes education
  • Able to read and write

Who cannot join

  • Presence of speech, hearing, or visual impairments
  • Presence of any other comorbid chronic disease
  • Presence of cognitive impairment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gülfidan Başer contact

4441251-7550

gulfidan.baser@karatay.edu.tr

Turkey (Türkiye)1 site, 1 recruiting

  • Etlik City Hospital

    Ankara, Yenimahalle

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Education Provided to Children With Type 1 Diabetes Using Gamification Methods on Health Literacy and Quality of Life: A Randomized Controlled Trial

Objective: This study aims to examine the effect of education provided through gamification methods on health literacy and quality of life in children diagnosed with type 1 diabetes (T1DM).

Materials and Methods: The study is planned as a randomized controlled trial with a pre-test-post-test, parallel design (1:1). The data for the study will be collected between January and April 2026 from patients diagnosed with type 1 diabetes mellitus at the Ankara Etlik City Hospital Pediatric-2 Endocrinology Service. The sample size has been determined to be 52 patients, with 26 in each of the experimental and control groups, based on data from similar studies in the literature. Data will be collected through individual interviews using a Personal Information Form, the Health Literacy Scale for Acute Complications of Diabetes in Children Aged 8-12 with type 1 diabetes mellitus, and the Quality of Life Scale for Children with Diabetes Mellitus. The gamified education will be provided by a researcher who has completed a 2.5-hour training program from BTK Academy. Informed Consent Forms and other forms will be completed by patients who meet the inclusion criteria and volunteer to participate. Randomization will be performed by someone other than the researcher. The experimental group will receive gamified education in addition to standard education, while the control group will receive only standard education. Data will be analyzed using the SPSS program. The research will be conducted in accordance with the principles of the Helsinki Declaration.

Read more

Findings: The findings of the study will be analyzed using SPSS after the application and data collection are completed.

Conclusion: The results of the study will be written after the application of the study and the collection of data, followed by the analysis of the data using SPSS and the determination of the findings.

Being tested
Gamification
Keywords
Type 1 Diabetes Mellitus, Gamification, Health literacy, Quality of life
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.

  • GamificationOther

    This intervention will provide randomized controlled evidence on a gamified diabetes education program for children, an approach that is currently limited in Türkiye, thereby contributing to evidence-based practice. In addition, by adopting a holistic approach that jointly evaluates health literacy and psychological symptoms, the program aims not only to improve knowledge but also to enhance quality of life through an innovative and effective educational model.

Study groups in NCT07409701
Study groupRoleWhat they receive
education provided through gamification methodsActive comparatorNot described
Receives: Other: Gamification
standardNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health Literacy Scale for Acute Complications of Diabetes in Children Aged 8-12

    The scale developed by Çövener and Yeşil (2024) consists of 18 items and three subscales. A highly significant positive correlation was found between the total scale score and the subfactors of knowledge about acute complications of diabetes, interpretation of encountered problems, and healthy lifestyle behaviors (p=0.000). In other words, as the total scale score increases, the subfactor scores also increase.

    Measured: Through study completion, an average of 1 year

Secondary outcomes (1)

  1. Quality of Life Scale for Children with Diabetes Mellitus

    A linear conversion is applied in the calculation of the total score on the scale, converting it to a score between 0 and 100. If the answer to the question is marked as never, it receives 100 points; if marked as rarely, it receives 75 points; if marked as sometimes, it receives 50 points; if marked as often, it receives 25 points; and if marked as almost always, it receives 0 points. The higher the total score, the better the perceived health-related quality of life.

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2026
  2. Study start25 Jan 2026
  3. Primary completion30 Apr 2026
  4. Study completion30 Apr 2027 (estimated)

Resources

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
Randomized controlled trial with a pre-test-post-test, parallel design (1:1)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07409701
Sponsor's protocol ID
2025/061
Status last verified
Feb 2026
First submitted
19 Jan 2026
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Akın, B., & Koçoğlu, D. (2017). Randomize kontrollü deneyler. *Hacettepe Üniversitesi Hemşirelik Fakültesi Dergisi*, 4(1), 73-92. American Diabetes Association. (2023). Standards of medical care in diabetes-2023. *Diabetes Care*, 46(Supplement\_1), S1-S291. Altundağ, S. (2018). Tip 1 diyabetli çocukların hastalığa uyumunda eğitimin ve sosyal desteğin etkisi. *Pamukkale Tıp Dergisi*, 11(2):137-144. Akyol Güner, T., Kuzu, A., & Bayraktaroğlu, T. (2020). Diyabetli bireylerde sağlık okuryazarlığı ve akılcı ilaç kullanımı arasındaki ilişki. *Turkish Journal of Diabetes and Obesity*, 4(3), 214-223. Ayar, D. (2012). *Diabetes Mellitus'lu çocuklarda yaşam kalitesi ölçeğinin geçerlik ve güvenirlik çalışması*. Yüksek lisans tezi, Dokuz Eylül Üniversitesi, Sağlık Bilimleri Enstitüsü, İzmir. [YÖK Ulusal Tez Merkezi](https://tez.yok.gov.tr/UlusalTezMerkezi/tezDetay.jsp?id=MEPAo2hK_UTZZs2oWMCStw&no=u1Mx6E6BUBcEGeGf10E0eg) Ayar, D., & Öztürk, C. (2015). Ebeveyn perspektifiyle pediatrik yaşam kalitesi envanteri diyabet modülünün Türkçe geçerlik güvenirlik çalışması. *Hemşirelikte Araştırma Geliştirme Dergisi*, 17(2/3), 1-9. Baştopçu, Ö., Arslan, S., Arslanoğlu, İ. (2021). Tip 1 diyabetli adölesanların uyku ve yaşam kalitesi ile psikolojik sağlamlık düzeyleri arasındaki ilişki. *International Anatolia Academic Online Journal Health Sciences*, 7(2). Bilgin, M., Yılmaz, A., & Kaya, S. (2020). Kronik hastalıklarda yaşam kalitesine genel bakış. *Erciyes Üniversitesi Sağlık Bilimleri Dergisi*, 9(1), 1-10. Bujanda, A., Bujanda, E. (2022). DIABESCAPE: An innovative educational project on diabetes. *Endocrinologia Diabetes Nutricion*, 69(6), 392-400. Çakmak, M. A., Simzari, W. (2024). Sağlıklı beslenmenin öğretilmesi ile ilgili bir oyunlaştırma modeli önerisi. *IGUSABDER*, 931-940. Delibaş, L., Erci, B. (2021). Sosyal bilişsel kuram temelli eğitimle tip 1 diyabetli çocukların hastalık yönetiminin desteklenmesi. *TJFMPC*, 15(2):404-13. Demir, G., Akcay, N. (2022). Diabetes education in child

Questions about this trial

What is this clinical trial studying?

A study testing Gamification in people with Type 1 Diabetes Mellitus, run by KTO Karatay 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 4 inclusion and 3 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 13 Aug 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 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 Gülfidan Başer (4441251-7550, gulfidan.baser@karatay.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health Literacy Scale for Acute Complications of Diabetes in Children Aged 8-12 (time frame: Through study completion, an average of 1 year). 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 NCT07409701, 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 13 Aug 2026.

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Clinical Trial NCT07409701 | AzTrials