Effect of an Educational Mobile Game on HbA1c and Glycemic Variability in Children With Type 1 Diabetes: A Randomized Controlled Trial

Cairo University76 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Diabetic Pediatric Patients With Type 1 Diabetes

Interventions

educational gameDEVICE

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.

Eligibility

Sex: ALLMin age: 7 YearsMax age: 14 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of pharmacy, Cairo University

Cairo, Egypt

Outcomes

Primary Outcomes

HbA1c

diabetes control that will be assessed by measuring the HbA1c level at baseline and at the end of the study in both groups

Time frame: 3 months

Secondary Outcomes

Different glycemic variability parameters and diabetes-related behavioral change

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.

Time frame: 3 months

Measurement of blood glucose control

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.

Time frame: 3 months

Usability and satisfaction

Usability and satisfaction of the patients will be assessed using a 10-item Arabic System Usability Scale (A-SUS) for mobile applications.

Time frame: 3 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.