Evaluation of a Mobile Application Designed to Support Type 1 Diabetic Patients in Adjusting Their Insulin Doses.

NCT07234500 | Enrolling By Invitation

• 1 other identifier: RECO624485
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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 randomly 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.

Conditions

Type One Diabetes Mellitus

Keywords

Type 1 diabetes; Adjuvant mobile app.; Randomized controlled trial; insulin dose adjustment; standard care

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Day 0) and Post-intervention (Month 3)

Study Arms (2)

mHealth Application + Standard Care

EXPERIMENTAL

Participants trained to use the mHealth mobile application as an adjuvant in addition to their usual care.

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.

Other: Standard Care (in control arm)

Interventions

mHealth Mobile Application DEVICE

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.

mHealth Application + Standard Care

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).

Standard Care Only; mHealth Application + Standard Care

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

Faiha Specialized Diabetes, Endocrine and Metabolism Center at Al-Faiha Teaching hospital

Basra, Basrah, Iraq

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD Candidate at College of pharmacy/University of Baghdad. Has MSC in Clinical Pharmacy and Lecturer at College of Pharmacy-University of Basrah.

Study Record Dates

• First Submitted: September 27, 2025
• First Posted: November 18, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)