The Effect of Mobile Application on the Pediatric Diabetes Management

Diabetes Mellitus, Type 1 Clinical Trial

— DM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05333185
• Other study ID #: NECMETTIN ERBAKAN U
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2024
• Source: Dokuz Eylul University
• Contact: Merve ASKIN CERAN, PhD student
• Phone: +905543132139
• Email: ms.cerancer3642[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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, itis 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: July 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent
• Child
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Behavioral:
• DIABOT (mobile application robot )
DIABOT (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.

Locations

Country	Name	City	State
Turkey	Necmettin Erbakan University Medical Faculty Hospital	Konya	Meram

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	HbA1c Levels	HBA1c levels of intervention and control groups will be compared at 3rd, 6th, 9th and 12th months.	3- 15 months
Primary	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	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.	3-15 months
Secondary	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.; hyperglycemia (high blood sugar)	3-15 months
Secondary	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	3-15 months