An interventional study of Gamification in Type 1 Diabetes Mellitus, sponsored by KTO Karatay University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by KTO Karatay University · Not applicable, Interventional, and Supportive care
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.
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 52 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →KTO Karatay University is the lead sponsor of 128 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
Other: Gamification
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.
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.
Time frame: Through study completion, an average of 1 year
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.
Time frame: Through study completion, an average of 1 year
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2026 to primary completion in Apr 2026, 3 months.
Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's 3 months is below that.
Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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