Type 1 Diabetes MellitusT1DM-APPNCT07499076
Mobile App-Supported Education for Diabetes Management in Adolescents With Type 1 Diabetes
A study testing Mobile Application-Supported Education in people with Type 1 Diabetes Mellitus, run by Deniz Akkaya Balcı at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aims to evaluate the effect of mobile application-supported education based on the Health Promotion Model on diabetes management in adolescents aged 12-18 years with Type 1 Diabetes Mellitus. The study will be conducted in a pediatric endocrinology clinic. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Mobile Application-Supported Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2024to 10 Nov 2025
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents aged between 12 and 18 years
- Diagnosed with Type 1 Diabetes Mellitus
- Able to use a smartphone
- Willing to participate in the study
- Provided informed consent (from parents/guardians if under 18)
Who cannot join
- Presence of any severe chronic disease other than Type 1 Diabetes
- Cognitive or psychiatric conditions that may affect participation
- Participation in another intervention study
- Inability to use a mobile application
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mobile Application-Supported Education Based on the Health Promotion Model on Diabetes Management in Adolescents With Type 1 Diabetes Mellitus
This randomized controlled study aims to evaluate the effect of mobile application-supported education based on the Health Promotion Model on diabetes management in adolescents aged 12-18 years with Type 1 Diabetes Mellitus. The study will be conducted in a pediatric endocrinology clinic. Participants will be randomly assigned to intervention and control groups. The intervention group will receive mobile application-based diabetes education, while the control group will receive standard care. Outcomes of the study include diabetes knowledge level, self-efficacy, blood glucose monitoring skills, and HbA1c levels.
Read the detailed description
This study is designed as a randomized controlled trial conducted in adolescents diagnosed with Type 1 Diabetes Mellitus. The intervention is based on the Health Promotion Model and delivered through a mobile application including educational modules and interactive content. Data will be collected using validated scales and clinical parameters such as HbA1c. The effectiveness of the intervention will be evaluated through pre-test, post-test, and follow-up measurements.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Mobile Application-Supported Education
- Keywords
- Type 1 Diabetes, Adolescent
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Application-Supported EducationBehavioural
A mobile application-based education program developed according to the Health Promotion Model to improve diabetes management in adolescents.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will receive mobile application-supported education based on the Health Promotion Model Receives: Behavioral: Mobile Application-Supported Education |
| Control Group | No intervention | Participants will receive standard care without additional mobile application-supported education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Management Self-Efficacy Score
Self-efficacy levels of adolescents will be assessed using a validated scale.
Measured: Baseline and 3 months after intervention
Diabetes Management Self-Efficacy Score
Self-efficacy levels of adolescents with type 1 diabetes will be measured using a validated diabetes self-efficacy scale.
Measured: Baseline and 3 months after intervent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start10 Dec 2024
- Primary completion10 Dec 2024
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to two groups: intervention and control. The intervention group will receive mobile application-supported education, while the control group will receive standard care.
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deniz Akkaya Balcı
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Deniz Akkaya Balcı, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499076
- Sponsor's protocol ID
- T1DM-APP-2024
- Acronym
- T1DM-APP
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile Application-Supported Education Based on the Health Promotion Model on Diabetes Management in Adolescents With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07499076
- Acronym / sponsor ID
- T1DM-APP / T1DM-APP-2024
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes, Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Deniz Akkaya BalcıUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 30 Mar 2026 (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 randomized controlled study aims to evaluate the effect of mobile application-supported education based on the Health Promotion Model on diabetes management in adolescents aged 12-18 years with Type 1 Diabetes Mellitus. The study will be conducted in a pediatric endocrinology clinic. Participants will be randomly assigned to intervention and control groups. The intervention group will receive mobile application-based diabetes education, while the control group will receive standard care. Outcomes of the study include diabetes knowledge level, self-efficacy, blood glucose monitoring skills, and HbA1c levels.
Detailed description
This study is designed as a randomized controlled trial conducted in adolescents diagnosed with Type 1 Diabetes Mellitus. The intervention is based on the Health Promotion Model and delivered through a mobile application including educational modules and interactive content. Data will be collected using validated scales and clinical parameters such as HbA1c. The effectiveness of the intervention will be evaluated through pre-test, post-test, and follow-up measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to two groups: intervention and control. The intervention group will receive mobile application-supported education, while the control group will receive standard care.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Mobile Application-Supported EducationParticipants will receive mobile application-supported education based on the Health Promotion Model |
| Control Group | No intervention | –Participants will receive standard care without additional mobile application-supported education. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Adolescents aged between 12 and 18 years
Key exclusion criteria (4 listed)
- Presence of any severe chronic disease other than Type 1 Diabetes
- Cognitive or psychiatric conditions that may affect participation
- Participation in another intervention study
- Inability to use a mobile application
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 |
|---|---|---|
| Mobile Application-Supported EducationA mobile application-based education program developed according to the Health Promotion Model to improve diabetes management in adolescents. | Behavioural | Intervention Group |
Primary outcome
Diabetes Management Self-Efficacy Score
Time frame: Baseline and 3 months after intervention
Self-efficacy levels of adolescents will be assessed using a validated scale.
Diabetes Management Self-Efficacy Score
Time frame: Baseline and 3 months after intervent
Self-efficacy levels of adolescents with type 1 diabetes will be measured using a validated diabetes self-efficacy scale.
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 30 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and ethical considerations.
Related trials for Type 1 Diabetes Mellitus
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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 Mobile Application-Supported Education in people with Type 1 Diabetes Mellitus, run by Deniz Akkaya Balcı at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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 30 Mar 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 Turkey (Türkiye). 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?
Diabetes Management Self-Efficacy Score (time frame: Baseline and 3 months after intervention). The study lists 2 primary outcomes in all. 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 30 Mar 2026.