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

March 20, 2025 updated by: Murat Bektaş, Dokuz Eylul University

The Effect of Mobile Application Robot Developed for Pediatric Diabetes Management on Children's Quality of Life, Diabetes Self-management and Physiological Parameters: Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

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:

  • 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.

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 )
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.
No Intervention: Control group
The control group will recieve standard diabetes treatment without any training intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diabetes Self-Management Scale for Children and parents mean score
Time Frame: 3- 15 months
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
Time Frame: 3-15 months
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
Time Frame: 3- 15 months
HBA1c levels of intervention and control groups will be compared at 3rd, 6th, 9th and 12th months.
3- 15 months
Blood Glucose Levels
Time Frame: 3-15 months
Blood Glucose Levels of intervention and control groups will be compared at 3rd, 6th, 9th and 12th months.
3-15 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the increase in the number of children exercising regularly compared to the baseline, according to the physical exercise registration form.
Time Frame: 3-15 months
Regular exercise status of the intervention and control groups at the 3rd, 6th, 9th and 12th months will be compared.
3-15 months
Number of hospitalizations and emergency department admissions
Time Frame: 3-15 months
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.
3-15 months
Regulating the Nutrition of Children according to their blood sugar level
Time Frame: 3-15 months
regulating the nutrition of children according to their blood sugar level using the mobile application
3-15 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dokuz Eylul University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Necmettin Erbakan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Murat BEKTAŞ, Prof. Dr., Dokuz Eylül University Faculty of Nursing
  • Principal Investigator: 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

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021/013

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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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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