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

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, 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 Randomization 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.

Inclusion criteria

• 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. -

Exclusion criteria

• 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