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

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 Overview

• Status: Completed
• Conditions: Diabetic Pediatric Patients With Type 1 Diabetes
• Intervention / Treatment: Device: educational game

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of pharmacy, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intervention group; The intervention group was provided, in addition to the usual care, with access to the mobile game as an APK file after a simple training for game usage.	Device: educational 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: Game will be presented in Arabic language.; 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.
No Intervention: control group; The control group was provided with usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	diabetes control that will be assessed by measuring the HbA1c level at baseline and at the end of the study in both groups	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 months
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.	3 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2023
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 20, 2023

Study Registration Dates

• First Submitted: January 14, 2023
• First Submitted That Met QC Criteria: January 14, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CL(3017)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No