Think-Find-Solve Activities for Insulin Self-Management in Type 1 Diabetes

July 17, 2026 updated by: Marmara University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

The child uses an insulin pump

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
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.
Other: Insulin Self-Management Know-Find-Solve Activity Book
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.
Active Comparator: Control Group
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.
Other: Routine education
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in insulin self-management level among children with type 1 diabetes
Time Frame: Baseline, 1 month after the intervention, and 3 months after the intervention
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.
Baseline, 1 month after the intervention, and 3 months after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in parent-reported insulin treatment self-management level of children with type 1 diabetes
Time Frame: Baseline, 1 month after the intervention, and 3 months after the intervention
The secondary outcome is the change in parent-reported insulin treatment self-management level of children with type 1 diabetes.
Baseline, 1 month after the intervention, and 3 months after the intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validity of the Insulin Self-Management Find-Search-Solve Activity Book
Time Frame: Baseline
The validity of the Insulin Self-Management Know-Find-Solve Activity Book will be evaluated as a pre-specified methodological outcome. Content validity will be assessed based on expert opinions using the Davis technique and the Content Validity Index. Face validity will be evaluated through pilot implementation with children with type 1 diabetes who meet the inclusion criteria. Feedback from children will be used to assess the clarity, comprehensibility, and suitability of the activity book.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2026

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

June 15, 2027

Study Registration Dates

First Submitted

June 22, 2026

First Submitted That Met QC Criteria

June 25, 2026

First Posted (Actual)

June 26, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30.04.2026/123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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