Type One Diabetes MellitusNCT07234500
Evaluation of a Mobile Application Designed to Support Type 1 Diabetic Patients in Adjusting Their Insulin Doses.
A study testing mHealth Mobile Application in people with Type One Diabetes Mellitus, run by University of Baghdad at 1 site in Iraq.
Trial summary
Title: Evaluating a Mobile Application for Insulin Management in Iraqi Type 1 Diabetes Patients. The goal of this clinical trial is to determine whether a mobile health application can improve insulin management and blood sugar control in Iraqi patients with Type 1 Diabetes aged over 15 years who are on intensive… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Type One Diabetes Mellitus
- What is being tested?
- mHealth Mobile Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIraq
- Study dates
- 1 Sep 2025to 30 Jul 2026
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients (≥15 years), with uncontrolled (HbA1c ≥ 7) type 1 diabetes who were treated with multiple daily insulin injections (MDI) for at least 3 months before the study date.
- Patients who are willing to test their blood glucose level at least 3 times daily during the study period.
- Participants who will give their informed consent to participate in the study. -
Who cannot join
- Pregnant woman or planning to be pregnant
- Patients at high risk of developing hypoglycemia (e.g., those with IHD, osteoporosis, hypoglycemia unawareness).
- Patients with psychiatric disorders.
- Patients who will be subjected to a major change in insulin dose (more than 20%) at the start or during the study period.
- Patients who don't use the application during the study period. The usage Metrics of the application will be watched on Google Analytics
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Faiha Specialized Diabetes, Endocrine and Metabolism Center at Al-Faiha Teaching hospital
Basra, Basrah
About this study
Title: Evaluating a Mobile Application for Insulin Management in Iraqi Type 1 Diabetes Patients.
The goal of this clinical trial is to determine whether a mobile health application can improve insulin management and blood sugar control in Iraqi patients with Type 1 Diabetes aged over 15 years who are on intensive insulin therapy. The main question it aims to answer is:
Read more
Does the use of the mobile application lead to a greater reduction in HbA1c levels compared to standard care alone?
Researchers will compare the group using the mobile application to the group receiving standard care alone to see if the application is more effective at improving glycemic control.
Participants will be assigned to one of two groups for the 3-month study.
Either use the mobile application to guide their daily insulin dose adjustments alongside standard care, or receive standard care alone.
Undergo blood tests (including HbA1c) and complete questionnaires about hypoglycemic events, insulin adherence, and quality of life.
Read the detailed description
Title: Evaluating a Mobile Application for Insulin Management in Iraqi Type 1 Diabetes Patients.
1.0 Study Design and Rationale This is a prospective, two-arm, quasi-randomized controlled clinical trial conducted at a specialized diabetes center in Iraq. The study is designed to evaluate the efficacy of a novel mobile health (mHealth) application, specifically developed for the Iraqi patient context, as an adjunctive tool for managing Type 1 Diabetes Mellitus (T1DM). The rationale is to determine if algorithm-guided, patient-self-managed insulin adjustments facilitated by the app can lead to superior glycemic control compared to traditional physician-led dose adjustments alone.
2.0 Methodology
2.1 Patient allocation and blinding: Participants will be allocated in a 1:1 ratio to either the intervention or control group. Allocation will be performed using a predefined alternation sequence based on the order of enrollment. Due to the nature of the intervention, participants cannot be blinded to their group assignment. However, outcome assessors and data analysts will be blinded to group allocation wherever possible.
2.2 Intervention:
Intervention Group: Participants will use the investigational mobile application daily for 12 weeks. The application will prompt users to input data on dietary intake, physical activity, and pre-meal blood glucose levels. Based on these inputs and a pre-programmed algorithm, the app will provide a recommended insulin dose for the user to administer. This will be in addition to standard care.
Control Group: Participants will continue to receive physician-led standard care for T1DM, which involves routine clinical follow-up and insulin dose adjustments as per the treating physician's discretion, without guidance from the mobile application.
2.3 Study Procedures and Timeline: The total study duration for each participant is 12 weeks.
Baseline Visit (Week 0): Eligible participants will provide informed consent, undergo demographic and clinical data collection, fasting blood sugar, HbA1c testing, and complete baseline questionnaires (insulin adherence, QOLSID).
Intervention Period (Weeks 1-12): The intervention group will use the mobile application. All participants will perform self-monitoring of blood glucose at least three times daily. Engagement and safety will be monitored through monthly structured telephone calls and ad-hoc WhatsApp communication for urgent queries.
Endpoint Visit (Week 12): All baseline assessments will be repeated, including HbA1c measurement and questionnaire completion. Application usage data will be downloaded from the intervention group's devices.
3.0 Data Management and Statistical Analysis Data will be collected using standardized case report forms (CRFs) and entered into a secure electronic database. All analyses will be conducted on an intention-to-treat basis. The primary outcome (change in HbA1c) will be analyzed using an analysis of covariance (ANCOVA), adjusting for baseline HbA1c. Secondary outcomes will be analyzed using appropriate parametric or non-parametric tests (e.g., t-tests, Mann-Whitney U tests, Chi-square tests). A p-value of <0.05 will be considered statistically significant.
4.0 Safety Monitoring Adverse events, particularly hypoglycemic events (blood glucose <70 mg/dL), will be actively monitored and recorded throughout the study. Any severe adverse events will be reported to the principal investigator and the institutional review board (IRB) within 24 hours.
- Conditions
- Type One Diabetes Mellitus
- Being tested
- mHealth Mobile Application, Standard Care (in control arm)
- Keywords
- Type 1 diabetes, Adjuvant mobile app., insulin dose adjustment, standard care
- 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.
mHealth Mobile ApplicationDevice
This is a culturally and linguistically tailored mobile health (mHealth) application designed for Arabic-speaking patients with Type 1 Diabetes in Iraq. The core function is to assist in calculating precise pre-meal insulin bolus doses by integrating: (1) carbohydrate intake, (2) current blood glucose level, and (3) planned physical activity.
Key tailored features include: a database of common Arabic cuisine for easy carbohydrate counting using food photographs (aiding patients with low health literacy), full Arabic language support, and algorithms calibrated for insulin types available in the Iraqi market. The app automatically calculates personalized insulin-to-carbohydrate ratios and correction factors based on the patient's total daily insulin dose, removing the need for manual entry and complex calculations.
Standard Care (in control arm)Other
Routine clinical management for type 1 diabetes, including regular insulin dose adjustments based on standard practice (e.g., clinic visits, HbA1c monitoring).
| Study group | Role | What they receive |
|---|---|---|
| mHealth Application + Standard Care | Experimental | Participants trained to use the mHealth mobile application as an adjuvant in addition to their usual care. Receives: Device: mHealth Mobile Application; Other: Standard Care (in control arm) |
| Standard Care Only | Active comparator | Participants will receive physician-led standard care for type 1 diabetes without using the mobile application. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycated Hemoglobin (HbA1c)
The difference in HbA1c levels, measured as a percentage (%), from baseline to the end of the study after 12 weeks. HbA1c will be measured from blood samples analyzed in a hospital laboratory. A negative change indicates improvement.
Measured: Baseline (Day 0) and Post-intervention (Month 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Sep 2025
- Primary completion30 Jun 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type One 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noor Kadhim, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234500
- Sponsor's protocol ID
- RECO624485
- Status last verified
- Nov 2025
- First submitted
- 27 Sep 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Mobile Application Designed to Support Type 1 Diabetic Patients in Adjusting Their Insulin Doses.
- ClinicalTrials.gov ID
- NCT07234500
- Acronym / sponsor ID
- RECO624485
- Conditions
- Type One Diabetes Mellitus
- Keywords
- Type 1 diabetes, Adjuvant mobile app., insulin dose adjustment, standard care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 18 Nov 2025 (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.
Title: Evaluating a Mobile Application for Insulin Management in Iraqi Type 1 Diabetes Patients.
The goal of this clinical trial is to determine whether a mobile health application can improve insulin management and blood sugar control in Iraqi patients with Type 1 Diabetes aged over 15 years who are on intensive insulin therapy. The main question it aims to answer is:
Does the use of the mobile application lead to a greater reduction in HbA1c levels compared to standard care alone?
Researchers will compare the group using the mobile application to the group receiving standard care alone to see if the application is more effective at improving glycemic control.
Participants will be assigned to one of two groups for the 3-month study.
Either use the mobile application to guide their daily insulin dose adjustments alongside standard care, or receive standard care alone.
Undergo blood tests (including HbA1c) and complete questionnaires about hypoglycemic events, insulin adherence, and quality of life.
Detailed description
Title: Evaluating a Mobile Application for Insulin Management in Iraqi Type 1 Diabetes Patients.
1.0 Study Design and Rationale This is a prospective, two-arm, quasi-randomized controlled clinical trial conducted at a specialized diabetes center in Iraq. The study is designed to evaluate the efficacy of a novel mobile health (mHealth) application, specifically developed for the Iraqi patient context, as an adjunctive tool for managing Type 1 Diabetes Mellitus (T1DM). The rationale is to determine if algorithm-guided, patient-self-managed insulin adjustments facilitated by the app can lead to superior glycemic control compared to traditional physician-led dose adjustments alone.
2.0 Methodology
2.1 Patient allocation and blinding: Participants will be allocated in a 1:1 ratio to either the intervention or control group. Allocation will be performed using a predefined alternation sequence based on the order of enrollment. Due to the nature of the intervention, participants cannot be blinded to their group assignment. However, outcome assessors and data analysts will be blinded to group allocation wherever possible.
2.2 Intervention:
Intervention Group: Participants will use the investigational mobile application daily for 12 weeks. The application will prompt users to input data on dietary intake, physical activity, and pre-meal blood glucose levels. Based on these inputs and a pre-programmed algorithm, the app will provide a recommended insulin dose for the user to administer. This will be in addition to standard care.
Control Group: Participants will continue to receive physician-led standard care for T1DM, which involves routine clinical follow-up and insulin dose adjustments as per the treating physician's discretion, without guidance from the mobile application.
2.3 Study Procedures and Timeline: The total study duration for each participant is 12 weeks.
Baseline Visit (Week 0): Eligible participants will provide informed consent, undergo demographic and clinical data collection, fasting blood sugar, HbA1c testing, and complete baseline questionnaires (insulin adherence, QOLSID).
Intervention Period (Weeks 1-12): The intervention group will use the mobile application. All participants will perform self-monitoring of blood glucose at least three times daily. Engagement and safety will be monitored through monthly structured telephone calls and ad-hoc WhatsApp communication for urgent queries.
Endpoint Visit (Week 12): All baseline assessments will be repeated, including HbA1c measurement and questionnaire completion. Application usage data will be downloaded from the intervention group's devices.
3.0 Data Management and Statistical Analysis Data will be collected using standardized case report forms (CRFs) and entered into a secure electronic database. All analyses will be conducted on an intention-to-treat basis. The primary outcome (change in HbA1c) will be analyzed using an analysis of covariance (ANCOVA), adjusting for baseline HbA1c. Secondary outcomes will be analyzed using appropriate parametric or non-parametric tests (e.g., t-tests, Mann-Whitney U tests, Chi-square tests). A p-value of <0.05 will be considered statistically significant.
4.0 Safety Monitoring Adverse events, particularly hypoglycemic events (blood glucose <70 mg/dL), will be actively monitored and recorded throughout the study. Any severe adverse events will be reported to the principal investigator and the institutional review board (IRB) within 24 hours.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth Application + Standard Care | Experimental | Device: mHealth Mobile Application, Other: Standard Care (in control arm)Participants trained to use the mHealth mobile application as an adjuvant in addition to their usual care. |
| Standard Care Only | Active comparator | Other: Standard Care (in control arm)Participants will receive physician-led standard care for type 1 diabetes without using the mobile application. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients (≥15 years), with uncontrolled (HbA1c ≥ 7) type 1 diabetes who were treated with multiple daily insulin injections (MDI) for at least 3 months before the study date.
- Patients who are willing to test their blood glucose level at least 3 times daily during the study period.
- Participants who will give their informed consent to participate in the study. -
Key exclusion criteria (5 listed)
- Pregnant woman or planning to be pregnant
- Patients at high risk of developing hypoglycemia (e.g., those with IHD, osteoporosis, hypoglycemia unawareness).
- Patients with psychiatric disorders.
- Patients who will be subjected to a major change in insulin dose (more than 20%) at the start or during the study period.
- Patients who don't use the application during the study period. The usage Metrics of the application will be watched on Google Analytics
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 |
|---|---|---|
| mHealth Mobile ApplicationThis is a culturally and linguistically tailored mobile health (mHealth) application designed for Arabic-speaking patients with Type 1 Diabetes in Iraq. The core function is to assist in calculating precise pre-meal insulin bolus doses by integrating: (1) carbohydrate intake, (2) current blood glucose level, and (3) planned physical activity. Key tailored features include: a database of common Arabic cuisine for easy carbohydrate counting using food photographs (aiding patients with low health literacy), full Arabic language support, and algorithms calibrated for insulin types available in the Iraqi market. The app automatically calculates personalized insulin-to-carbohydrate ratios and correction factors based on the patient's total daily insulin dose, removing the need for manual entry and complex calculations. | Device | mHealth Application + Standard Care |
| Standard Care (in control arm)Routine clinical management for type 1 diabetes, including regular insulin dose adjustments based on standard practice (e.g., clinic visits, HbA1c monitoring). | Other | Standard Care Only, mHealth Application + Standard Care |
Primary outcome
Change in Glycated Hemoglobin (HbA1c)
Time frame: Baseline (Day 0) and Post-intervention (Month 3)
The difference in HbA1c levels, measured as a percentage (%), from baseline to the end of the study after 12 weeks. HbA1c will be measured from blood samples analyzed in a hospital laboratory. A negative change indicates improvement.
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 11 Aug 2026.
- Individual participant dataSharing planned: No
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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 mHealth Mobile Application in people with Type One Diabetes Mellitus, run by University of Baghdad at 1 site in Iraq.
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 3 inclusion and 5 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 11 Aug 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 Iraq. 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?
Change in Glycated Hemoglobin (HbA1c) (time frame: Baseline (Day 0) and Post-intervention (Month 3)). 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 11 Aug 2026.