Diabetic Pediatric Patients With Type 1 DiabetesNCT05697484
Effect of an Educational Mobile Game on HbA1c and Glycemic Variability in Children With Type 1 Diabetes: A Randomized Controlled Trial
A study testing educational game in people with Diabetic Pediatric Patients With Type 1 Diabetes, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Diabetic Pediatric Patients With Type 1 Diabetes
- What is being tested?
- educational game
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2023to 20 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients age from 7 to 14 years old to be able to deal with and understand the game.
- Children previously diagnosed with type1 DM.
- Arabic speaker.
- Smart phone (android) access at home, either the mobile of the child or his/her parents.
Who cannot join
- 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
- Diabetic pediatric patients at goal with HbA1c < 7.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- educational game
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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:
- 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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | 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. Receives: Device: educational game |
| control group | No intervention | The control group was provided with usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
diabetes control that will be assessed by measuring the HbA1c level at baseline and at the end of the study in both groups
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start12 Jan 2023
- Primary completion1 Aug 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Pediatric Patients With Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mohammed Esmail Alsadek Sherif, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697484
- Sponsor's protocol ID
- CL(3017)
- Status last verified
- Jun 2026
- First submitted
- 14 Jan 2023
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Educational Mobile Game on HbA1c and Glycemic Variability in Children With Type 1 Diabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05697484
- Acronym / sponsor ID
- CL(3017)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Device: educational gameThe 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. |
| control group | No intervention | –The control group was provided with usual care. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric patients age from 7 to 14 years old to be able to deal with and understand the game.
- Children previously diagnosed with type1 DM.
- Arabic speaker.
- Smart phone (android) access at home, either the mobile of the child or his/her parents.
Key exclusion criteria (2 listed)
- 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
- Diabetic pediatric patients at goal with HbA1c < 7.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational gameControl 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. | Device | intervention group |
Primary outcome
HbA1c
Time frame: 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
3 secondary outcomes
Different glycemic variability parameters and diabetes-related behavioral change
Time frame: 3 months
Measurement of blood glucose control
Time frame: 3 months
Usability and satisfaction
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Diabetic Pediatric Patients With Type 1 Diabetes
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RecruitingObservational study
Semi-closed Loop Automated Insulin Therapy in the Pediatric Population Aged 2-6 Years With Type 1 Diabetes: Impact on Quality of Life and Glycemic Control
Type 1 Diabetes, Closed Loop
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational game in people with Diabetic Pediatric Patients With Type 1 Diabetes, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.