The Effect of Mobile Application Robot Developed for Pediatric Diabetes Management on Children With Diabetes Mellitus

NCT05333393 | Completed

• 1 other identifier: 2021/013
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Type 1 DM; It is a chronic metabolic disease that develops as a result of the destruction of pancreatic ß cells, which are responsible for insulin production. Although type 1 DM can occur at any age, the highest incidence is seen between the ages of 10-14. Especially in this age group (7-15 years), who are more social than the previous period with the emergence of diabetes symptoms, both physical restrictions and limitations in their emotional and social functionality permanently change the lives of children with diabetes. According to the International Diabetes Federation (IDF) 2019 data, it is estimated that the patients with Type 1 diabetes in the world are 1,110,100 children/adolescents. This number is increasing each year, and it is estimated that approximately 98,200 children and adolescents under the age of 15 are diagnosed with Type 1 diabetes each year. It is seen that there is an increase in the number of cases in young children in high-risk groups. Therefore, early diagnosis and initiation of treatment is a necessary step. The basic elements of type 1 diabetes treatment are; diabetes education, nutrition, exercise, insulin, blood sugar monitoring and psychosocial counseling. Recently; It is seen that the use of technology in children with diabetes has increased thanks to the opportunity to access information at any time, to choose the information according to one's own needs, to receive service when it is ready, to reduce costs in health, and to be educated at home due to limitations. Taking measures to prevent worsening of glycemic regulation and weight gain in patients with diabetes, especially in situations that cause social isolation such as pandemics, monitoring and management of patients with diabetes during the social isolation process, and enabling patients to access the information they need in a short time are of great importance in terms of diabetes tables. When the literature is examined, it is seen that there are many pages and mobile applications related to this. In this study, it is aimed to improve the self-management of children/adolescents with a mobile application that can be accessed from any device suitable for today. For this, it is aimed to create a mobile application that includes all sub-dimensions of diabetes self-management and contains content that other applications do not have.

Conditions

Diabetes Mellitus, Type 1; Children; Adolescent

Keywords

Type 1 Diabetes,; Children,; Self-Management,; Mobile Application

Outcome Measures

Primary Outcomes (4)

• Diabetes Self-Management Scale for Children and parents mean score

  The mean scores of the diabetes self-management scale for children and parents of the intervention and control groups were to be compared at the 3rd, 6th, 9th and 12th months.

  3- 15 months

• Quality of life Scale for Children With Diabetes Mellitus Mean Score

  The mean scores of the diabetes Quality of Life scale for children of the intervention and control groups were to be compared at the 3rd, 6th, 9th and 12th months.

  3-15 months

• HbA1c Levels

  HBA1c levels of intervention and control groups will be compared at 3rd, 6th, 9th and 12th months.

  3- 15 months

• Blood Glucose Levels

  Blood Glucose Levels of intervention and control groups will be compared at 3rd, 6th, 9th and 12th months.

  3-15 months

Secondary Outcomes (3)

• the increase in the number of children exercising regularly compared to the baseline, according to the physical exercise registration form.

  3-15 months

• Number of hospitalizations and emergency department admissions

  3-15 months

• Regulating the Nutrition of Children according to their blood sugar level

  3-15 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Children in the experimental group will be informed about the diabot application and how they will use the application to manage their disease processes. Children/adolescents in the study group and their parents will be evaluated 5 times, once every 3 months, through data collection tools. Data will be collected from the children/adolescents in the control group and their parents by means of pre-test and data collection tools 5 times, once every 3 months.

Behavioral: DİABOT (mobile application robot )

Control group

NO INTERVENTION

The control group will recieve standard diabetes treatment without any training intervention

Interventions

DİABOT (mobile application robot ) BEHAVIORAL

Thanks to the trainings given through the mobile application robot developed for pediatric diabetes management, it is aimed to have an effect on the quality of life, diabetes self-management and physiological parameter levels of children with Type 1 diabetes, and to easily obtain the information they need even when they cannot come to the outpatient clinic. In addition, thanks to the application robot, he will be able to create his own exercise program and determine his diet.

Experimental group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Be in the 7-12 age range
• Understanding and speaking Turkish
• No vision or hearing problems
• Having been diagnosed with Type 1 Diabetes Mellitus at least six months ago
• Parents and children must have an internet connection, computer, smartphone or tablet to use the Diabot application

You may not qualify if:

• The children who will participate in the research have another chronic disease together with diabetes,
• The children who will participate in the study have a neurological disease together with diabetes,
• No internet connection and no smartphone or tablet,
• Not having the ability to use the application.

Sponsors & Collaborators

• Dokuz Eylul University: lead
• Necmettin Erbakan University: collaborator

Study Sites (1)

Necmettin Erbakan University Medical Faculty Hospital

Konya, Meram, 42080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

• Murat BEKTAŞ, Prof. Dr.

  Dokuz Eylül University Faculty of Nursing

  STUDY DIRECTOR

• Merve AŞKIN CERAN, PhD Student

  Dokuz Eylül University Institute of Health Sciences

  PRINCIPAL INVESTIGATOR

• Beray SERVER EKLİOĞLU, Doç. Dr.

  Necmettin Erbakan University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single Blinded
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: The child with type 1 diabetes will be divided into two as the experimental and control group. Children in the experimental group will be informed about the diabot application and how they will use the application to manage their disease processes. Children/adolescents in the study group and their parents will be evaluated 5 times, once every 3 months, through data collection tools. Data will be collected from the children/adolescents in the control group and their parents by means of pre-test and data collection tools 5 times, once every 3 months. If the training is found effective after the study is completed, similar training will be given to the control group via the mobile application.

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 19, 2022
• Study Start: May 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)