Evaluation of a Mobile Application Designed to Support Type 1 Diabetic Patients in Adjusting Their Insulin Doses.
Phase: NA
Conditions: Type One Diabetes Mellitus
Sponsor: University of Baghdad

COVER PAGE 
Official Study Title: Assessment of mobile application designed to support patients with type 1 
diabetes in adjusting their insulin doses 
NCT Number: [To be assigned by ClinicalTrials.gov] 
Document Date: 23 September 2025 
Document Type: Study Protocol (Randomized Controlled Trial) 
Principal Investigator: Noor Kadhim Mohamed-Jawad  
Affiliation: College of Pharmacy, University of Baghdad, Iraq 
Brief Study Description: A randomized controlled trial to evaluate the effectiveness of a 
culturally adapted mobile application for insulin dose adjustment in Iraqi adults with poorly 
controlled type 1 diabetes compared to standard care alone. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL: RANDOMIZED CONTROLLED TRIAL 
Official Title: A Randomized Controlled Trial of a Mobile Application for Insulin Dose 
Adjustment in Iraqi Adults with Type 1 Diabetes 
NCT Number: [To be assigned by ClinicalTrials.gov]  
Protocol Version: 2.0 Date: 23 September 2025 
 1.0 STUDY IDENTIFICATION 
Principal Investigator: Noor Kadhim Mohamed-Jawad 
Affiliation: College of Pharmacy, University of Basrah, A PhD candidate at college of pharmacy 
, University of Baghdad 
Study Sites: Faiha Specialized Diabetes, Endocrine, and Metabolism Center in Basrah 
Endocrinology Center (FDMEC) , Basrah, Iraq. 
Study Design: Parallel-group, randomized controlled trial 
Allocation Ratio: 1:1 
2.0 BACKGROUND AND RATIONALE  
Type 1 diabetes mellitus (T1DM) requires complex insulin dose adjustments based on 
carbohydrate intake, blood glucose levels, and physical activity. Many patients in Iraq have poor 
glycemic control (HbA1c ≥8%) due to difficulties in performing these calculations. While 
numerous diabetes apps exist, few are culturally adapted for Arabic-speaking populations or 
designed for patients with low health literacy. This randomized controlled trial aims to rigorously 
evaluate a newly developed, evidence-based mobile application specifically designed for Iraqi 
T1DM patients. 
3.0 STUDY OBJECTIVES  
Primary Objective: 
To evaluate the effect of the mobile application on glycemic control (change in HbA1c from 
baseline to 3 months) compared to standard care alone. 
Secondary Objectives: 
To assess differences in medication adherence between groups 
To compare quality of life changes between groups 
To evaluate the frequency of hypoglycemic events between groups 
To assess user satisfaction and usability of the application (intervention group only) 

4.0 STUDY DESIGN 
Design: Prospective, parallel-group, randomized controlled trial 
Allocation: Computer-generated randomization with block randomization (block size 4-6) 
Blinding: Open non-blind study 
Duration: 3-month intervention period 
Follow-up: Baseline and 3-month assessments. In addition to monthly call and Whats-up 
communication as needed. 
5.0 RANDOMIZATION AND MASKING 
Randomization Procedure: 
Computer-generated random sequence using statistical software 
Blinding: Participants cannot be blinded due to nature of intervention.  
6.0 STUDY POPULATION 
Inclusion Criteria: 
1. Adults ≥15 years with T1DM  
2. HbA1c ≥7% at screening 
3. On multiple daily insulin injections (MDI) for ≥3 months 
4. Willing to perform self-monitoring of blood glucose ≥3 times daily 
5. Smartphone ownership and basic proficiency 
6. Provides informed consent 
Exclusion Criteria: 
1. Pregnancy, lactation, or planning pregnancy 
2. High hypoglycemia risk (hypoglycemia unawareness, recent severe hypoglycemia) 
3. Significant psychiatric disorders affecting adherence 
4. Visual or motor impairment preventing app use 
5. Participation in other diabetes intervention studies 
6. Major insulin dose change (>20%) anticipated during study period 
 
7.0 INTERVENTION 
Intervention Group (n=26): 
1. Training session on mobile application use (30-45 minutes) 
2. Application features: insulin dose calculator, educational content, glucose logging, alerts 
3. Monthly phone follow-up for adherence support (month 1,2, 3) 

4. Continues standard diabetes care 
5. Access to technical support hotline 
Control Group (n=26): 
1. Standard diabetes care only (no application access) 
2. Equivalent attention time with general health check  
3. Will receive application access after study completion if desire. 
8.0 OUTCOME MEASURES 
Primary Endpoint: 
Absolute change in HbA1c from baseline to 3 months 
Secondary Endpoints: 
1. Change in medication adherence score  
2. Change in quality of life score  
3. Number of hypoglycemic events (<70 mg/dL) per patient-month 
4. Severe hypoglycemia events requiring assistance 
5. System Usability Scale score (intervention group only) 
9.0 DATA COLLECTION SCHEDULE 
Assessment  
Baseline 
Month 1 
Month 2 
Month 3 
Informed Consent  
X 
 
 
 
Demographic/clinical 
data 
X 
 
 
X 
FBS measurement 
X 
 
 
X 
HbA1c measurement  
 
 
X 
Adherence 
questionnaire 
X 
 
 
X 
Quality of life 
questionnaire 
X 
 
 
X 
Hypoglycemia event 
X 
X 
X 
X 
System usability 
(intervention only) 
X 
 
 
X 
Monthly call 
 
X 
X 
X 
Adverse events 
 
X 
X 
X 
10.0 STATISTICAL ANALYSIS 
Analysis Principles: Intention-to-treat analysis for primary outcome 
Primary Analysis: Linear mixed model for HbA1c change (group × time interaction) 
Secondary Analyses: 
Chi-square tests for categorical outcomes 

T-tests or Mann-Whitney for continuous outcomes 
Repeated measures ANOVA for longitudinal data 
Subgroup analyses by baseline HbA1c, diabetes duration 
Software: SPSS version 29, R version 4.3 
Significance Level: p<0.05 (two-tailed) 
11.0 ETHICAL CONSIDERATIONS 
Approval: Required from University of Baghdad and Al-Faiha Endocrine Center ethics 
committees 
Informed Consent: Written consent obtained from all participants after detailed explanation of 
randomization process 
Confidentiality: Participant data de-identified, encrypted storage, access limited to research team 
Right to Withdraw: Participants may withdraw at any time without affecting standard care 
12.0 SAFETY MONITORING 
Stopping Rules: Study suspension if ≥3 severe hypoglycemia events related to app use 
13.0 DISSEMINATION PLAN 
Publication in peer-reviewed journals regardless of outcome 
Results shared with participants and local diabetes community