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

NCT07234500 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-11-18

No results posted yet for this study

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

Interventions

DEVICE

mHealth Mobile Application

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.

OTHER

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).

Sponsors & Collaborators

  • University of Baghdad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-06-30
Completion
2026-07-31

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07234500 on ClinicalTrials.gov