Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05333393 |
| Other study ID # |
2021/013 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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, 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.
