According to the results of a recent systematic review evaluating the impact of mobile apps on patients with T1DM in resource-limited countries [29], these apps can offer greater benefits to patients with T1DM in such settings, particularly when they include multiple features such as bolus insulin dose calculation, a blood glucose tracking system, patient reminders, and educational support. Consequently, the current app was developed to incorporate all these features. Additionally, all information was written in Arabic, and the app was designed to include data on the most common foods in Iraqi cuisine to ensure its relevance and specificity for Iraqi patients with T1DM. The app development steps are summarized in Figure 1.

Scientific contents of the app were obtained from the latest American Diabetes Association guideline [30] and the latest version of an essential textbook in therapeutics, “Applied Therapeutics: The Clinical Use of Drugs” [31]. Moreover, names and contents of common foods in the Iraqi cuisine were obtained from “A Self-Management Guide for Type 2 Diabetes Mellitus Patients from Middle Eastern Countries” and “Iraqi Healthy Food Guide” [32,33]. The app was programmed by the Satyadri Innovations LLP company (India) using Flutter version 3.38 (Google LLC). The development process continued from Oct 2024 to Apr 2025.

The app was developed to include many functionalities. The user interface presents the main functions on a central dashboard on the app’s home screen, allowing for easy navigation [Figure 2]. The main app functions include (1) bolus insulin dose calculation and (2) a digital logbook for recording and tracking the trend in blood glucose measurements with graphical presentation of the BG trend. These records can be downloaded and shared with a health care provider; (3) educational information covering essential topics in T1DM self-management such as insulin injection techniques, counting, hypoglycemia management, insulin storage, and sick days management rules; (4) suggested meals with detailed carbohydrate content for common Iraqi breakfast, lunch, and dinner; and (5) a consultation contact number.

The app also contains additional features such as reminder messages, which are sent 3 times daily (morning, afternoon, and evening) to prompt patients to use the app and to measure and record blood glucose level. Additionally, the app was designed to send alert messages to the user when alarming blood glucose levels are detected. These include instances of blood glucose exceeding the target threshold for 3 consecutive days and episodes of hypoglycemia. Upon detection, these notifications inform users of the situation and recommend an appropriate course of action. In addition, the digital logbook uses a color-coded system: blood glucose values above the target range are displayed in red with a “High” status note, while values within the normal range appear in green, facilitating immediate user awareness of glycemic excursions. The app was also designed to include a “Contact Us” button that allows patients to communicate directly with their physician in emergency situations, including sick days or frequent blood glucose fluctuations.

To protect sensitive patient information, the app implements robust privacy and security protocols. Patients must create a unique account with secure login credentials to access and manage their logbook. By default, patient-entered data is restricted from the health care provider view; clinical data sharing requires explicit consent, which users grant through an integrated opt-in privacy protocol.

The app was designed to calculate the bolus insulin dose and then displays the recommended dose that the user should inject before a meal through a sequential process. To personalize dosing, the app was designed to enable users to select the type of insulin they are using from a list of commercially available insulins in Iraq and input their current prescribed doses. To ensure the accuracy of these calculations, users with above-target HbA_1c levels were required to perform intensive capillary blood glucose monitoring for 3 consecutive days and record their results in a logbook. The treating endocrinologist then reviewed these logbooks to adjust insulin doses as clinically indicated. If the total daily insulin dose was changed, an additional 1‐3 days of logbook checking was performed. These patients were then instructed to enter their newly adjusted doses into the app. Following dose entry by the patient, the app automatically calculates the total daily dose of insulin (TDDI). Using this individualized data (TDDI and insulin type), the app automatically derives the carbohydrate-to-insulin ratio (CIR) and correction factor (CF) using the validated clinical equations shown in Textbox 1 [31,32].

To ensure the validity of the scientific contents of the app—including the bolus insulin dose calculation equations, proposed app functions, and educational content—it was sent to a multidisciplinary panel of 8 experts (5 clinical pharmacists, 1 endocrinologist, and 2 dietitians). Experts were selected based on their clinical and academic expertise in diabetes care. All experts were instructed to evaluate the overall accuracy and comprehensiveness of the provided information using a 3-point Likert scale and to offer comments when applicable. A content validity ratio (CVR) was used, in which values ≥0.875 were considered acceptable [38]. All experts rated the accuracy and comprehensiveness as optimal, yielding a perfect CVR of 1.00 for all core scientific parameters. However, some feedback comments were received. All feedback was systematically compiled, reviewed, and incorporated into a revised app prototype through a consensus process involving the research team. Following this process, all experts unanimously agreed that the information was accurate, comprehensive, and clinically appropriate.

Two new questionnaires were developed by study authors based on ideas from previous literature [39,40]. The first questionnaire was developed in the English language and designed to assess the acceptability, quality, benefits, and ease of use of the app from the perspective of health care professionals using a 3-point Likert scale [39,40]. The second questionnaire was developed in the Arabic language and designed to assess the acceptability, benefits, and ease of use of the app from the perspectives of patients with T1DM using a 3-point Likert scale [39-42].

To check content validity of these questionnaires, they were sent to a panel of experts (3 endocrinologists and 4 clinical pharmacists), and they were asked to assess the relevance and clarity of the questionnaire items using a dichotomous response and comments when necessary. They were also asked to assess the comprehensiveness of the questionnaire as a whole. A CVR was used, in which values of 1 were considered acceptable [38]. All items in both questionnaires were considered relevant (CVR=1). Moreover, comments were received regarding the wording of several items to improve clarity, including 3 items in the first questionnaire and 2 items in the second questionnaire. An expert recommended the addition of 2 additional items to both questionnaires to improve comprehensiveness. Therefore, the questionnaires were revised according to the given comments.

The final expert questionnaire comprised 12 items across 4 domains (usability, benefit to patients, benefit to providers, and satisfaction), while the patient questionnaire comprised 10 items across 3 domains (usability, benefit to patients, and satisfaction). All items used a 3-point Likert scale: agree, neutral, and disagree. An optional open-ended question was included in both surveys for participant feedback. Full questionnaires are provided in Multimedia Appendices 1 and 2.

This study was conducted in accordance with the International Ethical Guidelines for Health-related Research Involving Humans from the Council for International Organizations of Medical Sciences (CIOMS) and the Belmont Report. Ethical approval was obtained from the Research Ethics Committee of the University of Baghdad–College of Pharmacy (approval number: REC0624485). The committee approved the use of verbal informed consent, as the study involved only an app usability assessment with minimal risk and did not include any experimental interventions or invasive procedures. All participants (health care providers and patients) provided verbal informed consent prior to enrollment after being fully informed about the study’s purpose and their right to withdraw at any time. To ensure privacy and confidentiality, all collected data were anonymized and restricted solely to the research team. Participants did not receive any financial compensation for their involvement in this study.

Ten experts validated the app prototype, with their demographic characteristics shown in Table 2. The expert evaluation of the T1DM app showed positive feedback across all domains, with high percentages of “Agree” ratings for most statements. In the usability domain, a large majority of the experts found the app easy to use and its details easy to understand, while a minority raised a concern about time efficiency. In the benefit to the patients domain, most experts agreed that patients with T1DM could benefit from the app and rated the app highly for optimizing insulin dose calculation, reducing hypoglycemia, and improving adherence to insulin, although a small subset felt it performed poorly in that aspect. Regarding benefit to health care provider, the app was strongly endorsed for improving communication; however, assessments of its ability to reduce physician workload were more mixed, with the majority agreeing, while some remained neutral and a few disagreed. In the satisfaction domain, all experts agreed they would recommend it to their patients. The numerical details of the expert ratings for the app are shown in Table 3. Finally, the recommendations from the expert panel included incorporating both standard and local portion measurements (dietitian), integrating graphical trends into the blood glucose log (endocrinologist), and simplifying educational content with visual aids (clinical pharmacist). All suggestions were incorporated into a revised prototype prior to pilot testing with patients with T1DM.

Ten patients with T1DM completed the postintervention survey for the pilot study; their demographic characteristics are presented in Table 4. Patient evaluations reflected positive feedback across all assessment domains. In the usability/experience domain, the vast majority of patients found the app easy to use and time-efficient, and all agreed that the content was easily understood. In the benefits domain, all patients gave positive ratings for blood glucose tracking and enhanced adherence to insulin therapy, and all patients felt that the app improved their ability to manage blood glucose, while most believed it could reduce the risk of hypoglycemia. Finally, in the satisfaction domain, all patients expressed an intention to continue using the app and would recommend it to others (Table 5).

The current study highlights a logical progression from the development of a culturally adapted T1DM app to its pilot testing, integrating insights from both health care providers and patients with T1DM. Engaging both groups was critical to ensure clinical accuracy, usability, and practical relevance, consistent with established validation frameworks [46]. In this context, health care providers are best equipped to evaluate the app’s scientific content, clinical accuracy, and overall efficacy [47,48], whereas patients, as end users, are uniquely positioned to assess its usability, accessibility, and alignment with their daily self-management needs [48,49]. These findings confirm the app’s alignment with the clinical and practical needs of Iraqi patients with T1DM, and its ease of use establishes it as a tool for daily diabetes management.

The pilot study demonstrated strong agreement between experts and patients, especially regarding the app’s ease of use, which was attributed to its user-friendly design. Similar studies in Iraq have also found that users, regardless of educational background, perceive mobile apps as easy to use [44,45,50]. Most experts believed that the app’s details were clear for Iraqi patients with T1DM, a view supported by patients, who found the information understandable. This clarity was due to the use of Arabic, simplified data entry with food photographs, and avoidance of technical jargon. The study also found consensus that the app could quickly calculate insulin doses due to its automated design, which eliminates the need for manual calculations. This consensus on the app’s ease of use, clarity, and time efficiency confirms the app’s validity within the usability domain, thereby highlighting its suitability for use by Iraqi patients with T1DM.

Most experts agreed that the app effectively assists patients in administering accurate insulin doses—a process that many physicians are skeptical that patients can perform independently due to its complexity [51,52]. This confidence likely results from the app’s automated algorithm for insulin dose calculation, which considers key variables such as carbohydrate intake, postmeal exercise, and premeal blood glucose levels. Moreover, both experts and patients rated the app highly for reducing hypoglycemia risk. Unlike traditional methods that only consider carbohydrate intake and premeal glucose, this app also incorporates postmeal exercise—a variable that increases insulin sensitivity and hypoglycemic risk [53]. By integrating exercise into the algorithm, the app can better prevent or reduce hypoglycemia.

The high agreement among participants about the app’s role in enhancing patient adherence to insulin therapy is likely due to its reminder messages, which are known to boost medication adherence [54]. Moreover, the reduced risk of hypoglycemia and better glycemic control may serve as another motivator for enhancing patients’ adherence to insulin therapy [55-57].

Results also indicated that all patients found the app helpful for tracking blood glucose, while health care providers agreed that it facilitated monitoring of their patients’ blood glucose levels. Similar blood glucose monitoring features in other apps have been accepted by patients and providers [58-60], although none achieved universal acceptance. The strong support for this app may be due to its graphical representation of blood glucose trends, which helps users in identifying hyperglycemic or hypoglycemic patterns.

Another reported benefit of the developed app was its ability to improve communication between patients and health care providers, as confirmed by both groups. Although similar findings are limited in the literature, this benefit is logical and can be attributed to key app features: (1) educational information about diabetes and insulin therapy, which enhances patients’ knowledge and subsequently improves patient-provider communication [61]; (2) a blood glucose tracking system that can be easily reviewed by health care professionals; and (3) multiple communication channels, including email, phone, and WhatsApp, leading to more frequent and efficient interactions [62].

On the other hand, most of the participating health care providers considered the app to be effective in reducing the workload on physicians, possibly due to its ability to enhance patient self-management practices through its educational features and to optimize glycemic control through precise insulin dose calculations. Ultimately, these 2 features can reduce the workload on physicians and the burdens on the health care system by reducing the time needed to educate patients on self-management practices [63] and minimizing hospitalizations caused primarily by poor glycemic control [64].

The high satisfaction of patients and experts with the app, along with their willingness to continue using it and to recommend it to other patients with T1DM, may be attributed not only to its usability and clinical benefits but also to the fact that it is the first app specifically developed for Iraqi patients. This strong consensus supports the app’s overall validity.

Following pilot testing, the app was prepared for public release through structured beta testing. This phase served as a critical bridge between clinical validation and public deployment, aligning with established mHealth research life cycles that position beta testing as a prerequisite for subsequent clinical trial evaluation [65]. Incorporating real-world user feedback and technical stress-testing prior to release ensures the app’s stability across diverse device configurations. The app complies with global clinical software standards, satisfying Apple App Review Guideline 1.4.1 and Google Play Health Policy requirements alongside international data protection protocols. The final version of the app was registered on Google Play and the Apple Store and became publicly available for download in August 2025. Annual update cycles will address emerging technical issues, user feature requests, and guideline updates, establishing a foundation for future randomized controlled trials to confirm its efficacy and safety. Future plans include submitting the app to the Iraqi Ministry of Health for clinical validation and adoption among Iraqi patients.

The findings of this pilot study are limited by the small sample size, which restricts the generalizability of the results. Additionally, the short post-intervention follow-up interview period may be insufficient for participants to comprehensively trial the app. All assessment parameters were subjective, relying solely on participants’ perceptions, without objective measures to confirm the benefits of the app. A further limitation is the manual entry of blood glucose values, which increases the risk of unintentional transcription errors. However, this design choice accounts for the high cost and limited availability of continuous glucose monitoring in Iraq, where conventional self-monitoring of blood glucose remains the standard of care. Future iterations of the app should prioritize Bluetooth connectivity with affordable glucometers to minimize transcription errors and enhance data reliability. Finally, the use of a 3-point Likert scale, while chosen to reduce cognitive load and maximize completion rates for the target population [66], inherently reduces response variance and statistical sensitivity, potentially constraining the ability to detect finer perceptual gradations relative to multipoint alternatives [67,68]. This compromise remains defensible within the present pragmatic context, though future investigations using broader Likert ranges may yield higher measurement resolution.

The preliminary findings provide encouraging evidence that the new mobile app tested in this study is a feasible and acceptable decision-support tool for insulin dose adjustment among Iraqi patients with T1DM. Both end users and clinical experts highlighted the app’s high usability and supported its integration into routine care. However, these initial assessments focus on user perception rather than direct clinical impact. As a foundational feasibility study, this work establishes a clear rationale for a larger, adequately powered randomized controlled trial to evaluate the app’s true efficacy in optimizing glycemic control, lowering hypoglycemia risk, and improving patient quality of life.