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

NCT07670572 | Not Yet Recruiting

• 1 other identifier: 30.04.2026/123
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

type 1 diabetes; children; activity; insulin; self management; parent

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline, 1 month after the intervention, and 3 months after the intervention

Other Outcomes (1)

• Validity of the Insulin Self-Management Find-Search-Solve Activity Book

  Baseline

Study Arms (2)

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.

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.

Other: Routine education

Interventions

Routine education OTHER

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.

Control Group

Insulin Self-Management Know-Find-Solve Activity Book OTHER

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.

Experimental Group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• The child uses an insulin pump

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Hyperinsulinism

Central Study Contacts

Fatma Toksöz Güneş, MsC, PhD Candidate

CONTACT

+905055232738; f.toksoz1996@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, masking of participants - children and parents - and the researcher delivering the intervention is not feasible. However, to reduce measurement and analysis bias, masking will be maintained during the data analysis process by coding the groups as Group A and Group B. In addition, all statistical analyses will be performed by an independent statistician who will be masked to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)