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

Primary Purpose

Diabetes Mellitus, Type 1, Children, Adolescent

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
DİABOT (mobile application robot )
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus, Type 1 focused on measuring Type 1 Diabetes,, Children,, Self-Management,, Mobile Application

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Necmettin Erbakan University Medical Faculty Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
HbA1c Levels
HBA1c levels of intervention and control groups will be compared at 3rd, 6th, 9th and 12th months.
Blood Glucose Levels
Blood Glucose Levels of intervention and control groups will be compared at 3rd, 6th, 9th and 12th months.

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
March 21, 2022
Last Updated
February 14, 2023
Sponsor
Dokuz Eylul University
Collaborators
Necmettin Erbakan University
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1. Study Identification

Unique Protocol Identification Number
NCT05333393
Brief Title
The Effect of Mobile Application Robot Developed for Pediatric Diabetes Management on Children With Diabetes Mellitus
Acronym
DM
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
Collaborators
Necmettin Erbakan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Children, Adolescent
Keywords
Type 1 Diabetes,, Children,, Self-Management,, Mobile Application

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Masking Description
Single Blinded
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will recieve standard diabetes treatment without any training intervention
Intervention Type
Behavioral
Intervention Name(s)
DİABOT (mobile application robot )
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diabetes Self-Management Scale for Children and parents mean score
Description
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
Title
Quality of life Scale for Children With Diabetes Mellitus Mean Score
Description
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
Title
HbA1c Levels
Description
HBA1c levels of intervention and control groups will be compared at 3rd, 6th, 9th and 12th months.
Time Frame
3- 15 months
Title
Blood Glucose Levels
Description
Blood Glucose Levels of intervention and control groups will be compared at 3rd, 6th, 9th and 12th months.
Time Frame
3-15 months
Secondary Outcome Measure Information:
Title
the increase in the number of children exercising regularly compared to the baseline, according to the physical exercise registration form.
Description
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
Title
Number of hospitalizations and emergency department admissions
Description
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
Title
Regulating the Nutrition of Children according to their blood sugar level
Description
regulating the nutrition of children according to their blood sugar level using the mobile application
Time Frame
3-15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Merve AŞKIN CERAN, PhD student
Phone
+905543132139
Email
ms.cerancer3642@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Murat BEKTAŞ, Prof.Dr.
Phone
+905326814737
Email
muratbektas35@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murat BEKTAŞ, Prof. Dr.
Organizational Affiliation
Dokuz Eylül University Faculty of Nursing
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Merve AŞKIN CERAN, PhD Student
Organizational Affiliation
Dokuz Eylül University Institute of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Beray SERVER EKLİOĞLU, Doç. Dr.
Organizational Affiliation
Necmettin Erbakan University Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Necmettin Erbakan University Medical Faculty Hospital
City
Konya
State/Province
Meram
ZIP/Postal Code
42080
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beray S EKLİOĞLU, Doç. Dr.
Phone
+905322244725
Email
berayserver@hotmail.com
First Name & Middle Initial & Last Name & Degree
MERVE AŞKIN CERAN, PhD Student
Phone
+905543132139
Email
ms.cerancer3642@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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