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CompletedNCT05333393DMUpdated Mar 24, 2025

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

An interventional study of DİABOT (mobile application robot ) in Diabetes Mellitus, Type 1, Children and Adolescent, sponsored by Dokuz Eylul University. Completed at 1 site in Turkey. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-03-24.

Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
7 Years to 12 Years
Sex
All
01

Study 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.

Read the detailed description

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. When the previously developed mobile application programs and their features were investigated for this study, a search was made with the keywords "Diabetes", "Type 1 DM", "T1DM" in the Play Store and App Store, and a total of 70 applications were reached. When participants look at the features of these applications, it is seen that the educational contents are specially designed for adults and most of them are in foreign languages. Blood sugar monitoring, exercise duration and type, carbohydrate levels and blood pressure values can be followed through programs, only 9 of which are in Turkish. When these applications are compared with the mobile application robot that participants plan to develop for diabetes management; Being the first Turkish mobile application robot specially designed for children with diabetes, having age-specific content, having a whatsapp business api application within the program, where they can reach the healthcare professional 24/7, sending personalized daily tips, synchronized use of the child and parent, having a voice response system, game-based It is among the privileges of the program that it includes training, digital technologies in health", "Science, Technology and Society", "Information and information technologies", being among the priority areas, and meeting the 11th Development targets of the Grand National Assembly of Turkey. In addition to contributing to the economy of our country by preventing acute and chronic complications in children, increasing the quality of life of children, bringing a new application to the field of health technologies, contributing to the fields of child health and diseases and pediatric health and diseases nursing, this robot participants will make for pediatric patients with diabetes. It is foreseen that the publications and presentations in the scientific fields will increase the scientific visibility and prestige of our country and will have a widespread impact at the international level.

02

Conditions studied

  • Diabetes Mellitus, Type 1
  • Children
  • Adolescent

Keywords

  • Type 1 Diabetes,
  • Children,
  • Self-Management,
  • Mobile Application
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 34 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Dokuz Eylul University is the lead sponsor of 252 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Experimental 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.

    Behavioral: DİABOT (mobile application robot )

  • No intervention
    Control group

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

Interventions

  • BehavioralDİABOT (mobile application robot )

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3- 15 months

  2. 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.

    Time frame: 3-15 months

  3. HbA1c Levels

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

    Time frame: 3- 15 months

  4. Blood Glucose Levels

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

    Time frame: 3-15 months

Secondary outcomes

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

    Regular exercise status of the intervention and control groups at the 3rd, 6th, 9th and 12th months will be compared.

    Time frame: 3-15 months

  2. Number of hospitalizations and emergency department admissions

    The number of hospitalizations and admissions to the emergency department in the 3rd, 6th, 9th and 12th months of the intervention and control groups will be compared. Applications will be determined by hospitalization and emergency service application form.

    Time frame: 3-15 months

  3. Regulating the Nutrition of Children according to their blood sugar level

    regulating the nutrition of children according to their blood sugar level using the mobile application

    Time frame: 3-15 months

07

Study locations

1 site
  • Necmettin Erbakan University Medical Faculty Hospital
    Konya, Meram 42080, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05333393
Lead sponsor
Dokuz Eylul University
Collaborators
Necmettin Erbakan University
Responsible party
Murat Bektaş (Prof. Dr., Dokuz Eylul University) — Principal investigator
First posted
Apr 19, 2022
Start date
May 1, 2023
Primary completion
Jun 1, 2024
Completion
Jul 1, 2024
Last update
Mar 24, 2025

Study contacts

Murat BEKTAŞ, Prof. Dr.
study director · Dokuz Eylül University Faculty of Nursing
Merve AŞKIN CERAN, PhD Student
principal investigator · Dokuz Eylül University Institute of Health Sciences
Beray SERVER EKLİOĞLU, Doç. Dr.
principal investigator · Necmettin Erbakan University Faculty of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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