Diabetic Pediatric Patients With Type 1 Diabetes
Conditions
Brief summary
This is a prospective randomized parallel two group pharmacist-led interventional study. The study will involve introduction of the mobile game to pediatric diabetic patients to improve their blood glucose level. The outcomes to be measured are HbA1c and glycemic variability parameters, patient satisfaction and behavioral changes in pediatric patients with type1 diabetes mellitus
Interventions
DEVICEeducational game
Control group will be provided with usual care. Intervention group will be provided in addition to the usual care, an access to the mobile game after a simple training for game usage. Both groups will be followed for a period of 3 months. The mobile game is planned to have the following design: 1. Game will be presented in Arabic language. 2. The game will consist of four levels. a. At the beginning of each level there will be an educational video that the patient must watch in order to be allowed to start the level.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
1. Pediatric patients age from 7 to 14 years old to be able to deal with and understand the game. 2. Children previously diagnosed with type1 DM. 3. Arabic speaker. 4. Smart phone (android) access at home, either the mobile of the child or his/her parents.
Exclusion criteria
1. Severe cognitive or psychiatric conditions that prevent a patient from understanding the game. any disorder that significantly impairs the cognitive function of an individual to the point where normal functioning in society is impossible without treatment ,examples: dementia- developmental disorders-motor skills disorders- amnesia- substance induced cognitive impairment)25 2. Diabetic pediatric patients at goal with HbA1c \< 7.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 3 months | diabetes control that will be assessed by measuring the HbA1c level at baseline and at the end of the study in both groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Different glycemic variability parameters and diabetes-related behavioral change | 3 months | The disease care activities of pediatric diabetic patients will be measured at baseline and at the end of the study after 3 months using The Arabic Summary of Diabetes Self-Care Activities measure. The glycemic variability was also evaluated at the end of the study period using different parameters: CV, MAGE, MAD, TIR. |
| Measurement of blood glucose control | 3 months | the random blood glucose level of pediatric patients will be measured by themselves or by their parents on daily basis using glucometer and the reading will be recorded until next visit. |
| Usability and satisfaction | 3 months | Usability and satisfaction of the patients will be assessed using a 10-item Arabic System Usability Scale (A-SUS) for mobile applications. |
Countries
Egypt
Outcome results
None listed