Type 1 DiabetesNCT07670572
Think-Find-Solve Activities for Insulin Self-Management in Type 1 Diabetes
A study testing Insulin Self-Management Know-Find-Solve Activity Book and Routine education in people with Type 1 Diabetes and Children, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Children with type 1 diabetes require lifelong insulin therapy. However, improper management of insulin therapy may lead to serious, potentially life-threatening complications. The aim of this study is to examine the effect of an activity book developed for insulin therapy on insulin self-management among children… Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Type 1 Diabetes, Children, Activity
- What is being tested?
- Insulin Self-Management Know-Find-Solve Activity Book and Routine education
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2026to 15 Jun 2027
- Phase
- Interventional
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
- For the child:
- Diagnosed with Type 1 diabetes Aged between 8 and 12 years Able to read and write Able to understand and speak Turkish Diagnosed with diabetes for at least one year Regularly attending routine three-month outpatient clinic follow-ups Having no other diseases or medical conditions aside from diabetes The child agrees to participate in the study
- -For the Parent: Being the mother or father of the child with Type 1 diabetes Being the primary caregiver responsible for the child Able to read and write Agrees to participate in the study
Who cannot join
- The child uses an insulin pump
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University
Istanbul
Marmara University, +905055232738, f.toksoz1996@gmail.com
About this study
Official title: The Effect of Think-Find-Solve Activities on Insulin Self-Management in Children With Type 1 Diabetes: A Randomized Controlled Trial
Children with type 1 diabetes require lifelong insulin therapy. However, improper management of insulin therapy may lead to serious, potentially life-threatening complications. The aim of this study is to examine the effect of an activity book developed for insulin therapy on insulin self-management among children with type 1 diabetes and their parents. The study is designed as a cluster randomized controlled experimental trial at the center level, including pre-test, 1- month, and 3-month follow-up measurements. The study will be initiated after obtaining ethical approval and institutional permissions. The sample will consist of children aged 8-12 years with type 1 diabetes and their parents. The study will be conducted in two different hospitals in Istanbul; using cluster randomization, one hospital will be assigned to the intervention group and the other to the control group. Prior to the main study, a pilot study will be conducted with 15 participants in each group, and the sample size will be calculated using G*Power based on the pilot data. Data will be collected using the "Descriptive Information Form for Children with Diabetes" and the "Insulin Treatment Self-Management Scale (ITSMS) - Child (8-18 years) and Parent Forms." The "Find-Solve-Learn Insulin Self-Management Activity Book" will be applied to the children in the intervention group. The children will be monitored to complete the activity book at least twice a month for three months, and feedback will be obtained from their families regarding the process. The data collection process will include pre-test, 1-month, and 3-month follow-up measurements. The obtained data will be analyzed using appropriate statistical methods.
- Conditions
- Type 1 Diabetes, Children, Activity, Insulin, Self Management, Parent
- Being tested
- Insulin Self-Management Know-Find-Solve Activity Book, Routine education
- Keywords
- type 1 diabetes, children, activity, insulin, self management, parent
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin Self-Management Know-Find-Solve Activity BookOther
The Insulin Self-Management Find-Search-Solve Activity Book was developed based on national and international literature to improve insulin-related self-management skills in children aged 8-12 years with type 1 diabetes. It aims to help children distinguish correct and incorrect insulin practices, take responsibility, make appropriate decisions, and apply their knowledge in daily life. The erasable and reusable book was designed to be safe and child-friendly. It contains 19 activities across 22 pages, including puzzles, word searches, matching, coloring, fill-in-the-blanks, true-false questions, riddles, and identification of insulin injection sites. Six experts evaluated the book, and the overall Content Validity Index calculated using the Davis technique was 0.98. Following pilot testing, the book will be finalized according to participant feedback.
Routine educationOther
Parents' contact information will be obtained, and the follow-up process will be maintained. The same data collection tools will be administered at time points parallel to those of the intervention group. After completion of the study, in line with the principle of ethical equity, children in the control group will also be given the "Insulin Self-Management Know-Find-Solve Activity Book" as a gift.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | After the pre-test, children in the intervention group will receive the intervention using the "Insulin Self-Management Know-Find-Solve Activity Book," in addition to the standard education provided by diabetes nurses in accordance with the Ministry of Health Diabetes Educator Guide. The researcher will explain how to use the activity book, and the book will be given to the children to complete at home. Parents' contact information will be obtained, and children will be asked to complete the activities in the book at least twice a month for 3 months. Throughout the process, families will be contacted to monitor the implementation of the activities and to obtain feedback on the completed sections. Questions from children and parents regarding the activities will be answered by the researcher. Follow-up measurements will be conducted at the end of the 1st and 3rd months after the intervention. Receives: Other: Insulin Self-Management Know-Find-Solve Activity Book |
| Control Group | Active comparator | Children in the control group will not receive any additional intervention other than the standard education provided by diabetes nurses in accordance with the Ministry of Health Diabetes Educator Guide. Receives: Other: Routine education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin self-management level among children with type 1 diabetes
The primary outcome is the change in insulin treatment-related self-management level of children with type 1 diabetes. Higher scores will indicate better insulin self-management.
Measured: Baseline, 1 month after the intervention, and 3 months after the intervention
Secondary outcomes (1)
Change in parent-reported insulin treatment self-management level of children with type 1 diabetes
The secondary outcome is the change in parent-reported insulin treatment self-management level of children with type 1 diabetes.
Measured: Baseline, 1 month after the intervention, and 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start5 Oct 2026
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
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 1 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
- This study will be conducted using an experimental, cluster-randomized controlled design at the center level, with measurements at pre-test, post-test (1 month), and 3-month follow-up.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670572
- Sponsor's protocol ID
- 30.04.2026/123
- Status last verified
- Oct 2026
- First submitted
- 22 Jun 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Ogle, G. D., Wang, F., Haynes, A., Gregory, G. A., King, T. W., Deng, K., ... & Maniam, J. (2025). Global type 1 diabetes prevalence, incidence, and mortality estimates 2025: Results from the International diabetes Federation Atlas, and the T1D Index Version 3.0. Diabetes Research and Clinical Practice, 112277. 2. T.C. Sağlık Bakanlığı Halk Sağlığı Genel Müdürlüğü,. 2020. Çocukluk Çağı Diyabeti Eğitimci Rehberi.; Ankara. Alban Tanıtım. ISBN 978-975-590-778-9. 3. WHO, 2024. Health literacy. https://www.who.int/news-room/fact-sheets/detail/health-literacy?utm_source=chatgpt.com 4. Catarino M, Charepe Z, Festas C. Promotion of Self-Management of Chronic Disease in Children and Teenagers: Scoping Review. Healthcare (Basel). 2021 Nov 27;9(12):1642. doi: 10.3390/healthcare9121642. PMID: 34946368; PMCID: PMC8701924. 5. Çövener Özçelik, Ç., Aktaş, E., Şen Celasin, N., Karahan Okuroğlu, G., & Şahin, Ş. (2019). The Development and Validation of a Turkish Insulin Treatment Self-management Scale Child Form (Ages 8-18) and Parent Form. Journal of Clinical Research in Pediatric Endocrinology, 11(3), 278-286. https://doi.org/10.4274/jcrpe.galenos.2019.2019.0026 6. Johnson, D., Deterding, S., Kuhn, K.-A., Staneva, A., Stoyanov, S., & Hides, L. (2016). Gamification for health and wellbeing: A systematic review of the literature. Internet Interventions, 6, 89-106. 7. UNICEF 2016. Game-Based & Interactive Learning Activities for Early Years. MINISTRY OF EDUCATION GAME-BASED TEACHING & LEARNING GRADES 1 - 3 Integrated Curriculum TEACHERS' MANUAL 1ST EDITIONErişim: https://www.unicef.org/jamaica/media/4646/file/Game-Based%20Manual.pdf 8. Sarasmita, M. A., Lee, Y. H., Chan, F. Y., & Chen, H. Y. (2024). Digital serious games to promote behavior change in children with chronic diseases: scoping review and development of a self-management learning framework. Journal of Medical Internet Research, 26, e49692. 9. Rafeezadeh, E., Ghaemi, N., HEIDARIAN, M. H., & Rezaeian, A. (2019). Effect of