Type 2 diabetes mellitus (T2DM) has emerged as a significant global health concern, with a worldwide prevalence of 537 million adults in 2021, and it is projected to rise to 783 million by 2045 [1]. In 2016, 9.7% of Bruneians aged between 18 and 69 years were diagnosed with diabetes [2]. Diabetes is the third leading cause of death in Brunei Darussalam, accounting for 10.1% of total deaths in 2017 [3]. Therefore, there is a need for effective management strategies tailored for patients with T2DM to achieve target glycemic control and reduce the risks of developing complications. This will lead to more efficient use of health resources.

In Brunei Darussalam, diabetes-related health care costs strain the national budget and heighten demand for services necessary to manage complications related to diabetes. The global cost of diabetes was estimated at US $966 billion in 2021 and is projected to rise to US $1.03 trillion by 2045 [1]. This burden includes direct medical expenses and indirect costs from increased prescription use, costly hospital services, and complications that can reduce overall productivity and lead to unemployment [4,5].

T2DM is a chronic disease that can lead to severe complications if not managed appropriately [6]. This underscores the critical role of self-management. Effective lifestyle management, which incorporates regular physical activity, a healthy diet, and medication adherence, can reduce both disease complication risks and health care costs [7]. By using SMART (specific, measurable, achievable, relevant, and time-bound) goals and behavioral techniques, individuals can improve their diabetes control and disease outcomes [8]. Recent studies have demonstrated that digital health interventions favorably impact glycemic control, patient adherence, and engagement [9,10]. Additionally, mobile health (mHealth) apps have been shown to positively improve health self-management practices on chronic conditions [11-13].

The digitalization of health care can further benefit the management of chronic diseases, such as T2DM [14]. With mobile ownership reaching 78% globally [15], health care can access a broad audience, enhancing health equity by providing vital information and resources. This accessibility equips underserved populations with tools for effective self-management, such as tracking health metrics and connecting with health care providers for personalized guidance.

BruHealth is the national mHealth app and health care portal in Brunei Darussalam, initially developed to mitigate COVID-19 spread. It has since evolved into a comprehensive digital health solution, benefiting the general population. The app is synchronized with the Brunei Darussalam Health Care Information and Management System (BruHIMS), where 95% of the population has active health records, allowing real-time access to health care data. Users can view their health records through BruHealth, enabling them to monitor their health status and access their blood test results. Beyond pandemic-related features, BruHealth now offers online appointment scheduling, health assessments, and access to medical articles on topics such as nutrition and lifestyle. By providing an accessible, user-friendly platform, BruHealth promotes the adoption of digital health technologies while allowing users to manage their health effectively [16].

Most existing global digital therapeutics (DTx) apps function as stand-alone tools, often relying on self-reported data and offering limited integration with national health systems. These apps frequently incur additional costs to users and typically focus on a single behavioral domain, such as diet tracking or medication adherence, thereby limiting their impact. The BALANCE program, delivered through BruHealth, adopts a holistic and culturally contextualized approach to diabetes prevention and management. The program addresses multiple lifestyle domains and provides education that has been adapted to the lifestyle in Brunei. Through integration with reliable wearables and BruHIMS, data captured can be used to create an appropriate health plan, enabling users to monitor their condition more seamlessly. This centralized and personalized system overcomes the key limitations of conventional DTx tools, particularly by offering a tailored and accessible solution for Brunei’s population [17]. The digitalization of this tool also increases accessibility to services and education that would otherwise be available only in person.

DTx are software-based treatments that deliver interventions with the best available evidence to manage or prevent diseases. They supplement or replace traditional therapies and are prescribed for chronic conditions such as diabetes and mental health disorders. In Brunei Darussalam, a DTx module focused on the management of T2DM (diabetes mellitus DTx [DM DTx]) has been developed.

The benefits of the DM DTx include patient education on diabetes management through lifestyle adjustments for better glycemic control, and real-time advice that has been designed to seamlessly integrate into daily activities, thus enabling patients to self-manage their diabetes with greater confidence. DM DTx may improve self-management and the quality of life of individuals with T2DM while paving the way for a more efficient and effective health care model.

The DM DTx module consists of a digital lifestyle intervention (named the BALANCE program, which is integrated into the BruHealth app) and a health care professional (HCP) portal where health coaches can interact with their patients and help them manage their condition. The BALANCE program has evolved from a previous pilot study conducted to evaluate the efficacy and feasibility of a digital lifestyle intervention for T2DM [18]. The pilot intervention program was designed with the expertise of endocrinologists and dietitians based on national clinical guidelines and evidence-based practice in diabetes management. Following further refinement and complete digitalization of the initial program, our study aims to assess the potential impact of a T2DM digital intervention that uses a fully online management approach.

Separately, as Brunei Darussalam has a Muslim-majority community, there is an optional component within the DM DTx offered to Muslim participants as an opportunistic way of gaining more insights into their fasting practices during the last Ramadan. Studies have shown that a significant number of Muslim patients in Brunei Darussalam with diabetes fast during Ramadan. For instance, a study found that 93.4% of participants fasted during Ramadan, with an average of 24.1 days. This optional component in the DM DTx could provide valuable insights into how fasting impacts diabetes management and help tailor more effective treatment plans for Muslim patients [19].

Our study aims to evaluate the efficacy of the DM DTx in managing patients with T2DM by delivering digital lifestyle interventions through an easily accessible platform (BruHealth), and to evaluate participants’ feedback to improve the app’s content and structure for better user experience.

The primary objective is to determine the proportion of participants who achieve at least a 0.6% reduction in glycated hemoglobin (HbA_1c) from baseline following a 16-week lifestyle intervention provided by the DM DTx module. Secondary objectives are (1) to evaluate overall changes in HbA_1c, fasting lipid profile, fasting blood glucose, BMI, and waist circumference over a 16-week period; (2) to analyze participants’ feedback on the BALANCE program; and (3) to evaluate fasting experience among Muslims with T2DM during Ramadan and to calculate their fasting risk using the International Diabetes Federation-Diabetes and Ramadan Alliance Risk (IDF-DAR) score [20].

This is a single-arm, nonrandomized intervention study that involves the use of BALANCE, a 16-week diabetes lifestyle management program (described in more detail subsequently under the “Intervention” section). Patients with T2DM are enrolled and taught diabetes self-management with structured educational courses, and their progress is monitored through the DM DTx with dedicated health coaches.

Anthropometric measurements are taken at baseline and at the end of the study. These include BMI (height and weight) and waist circumference. A fasting blood sample is also taken at baseline and at the end of the study. The blood tests include the following:

Serum creatinine is also measured at baseline if there is no result available within 1 year of enrollment.

Descriptive statistics will be calculated to summarize the demographic profile of the research population and the primary and secondary outcomes outlined earlier. The mean, median, SD, and IQR will be reported for continuous variables, whereas frequencies and percentages will be used for categorical variables. Depending on the distribution of independent variables, appropriate paired statistical tests, such as the paired t test or the Wilcoxon signed-rank test, will be used to assess statistically significant differences between outcomes before and after treatment for both primary and secondary measures. Additionally, subgroup analyses will be conducted to assess for any significant differences in primary and secondary outcomes based on patient classifications, such as BMI categories, diabetic medication use profiles, or levels of engagement with the educational modules and health coaches in the BALANCE program.

Participants are withdrawn from the study if it is deemed that continued participation in the study poses significant health risks to them. These considerations include the following: (1) participants who require hospitalization during the study period (which may or may not be related to the study), (2) those deemed by clinical investigators to require immediate adjustments to their diabetes medications as delay may cause harm, and (3) those who fail to provide 2 local emergency contacts.

An online participant information sheet and consent form are available on the DM DTx module in the BruHealth app. Interested individuals are required to complete the online consent form before proceeding to complete the screening questionnaire. All participants are informed that their personal information will be kept confidential and securely stored within the Brunei Health Information Management System and BruHealth platforms, which follow national data protection and privacy standards. Identifying details will not be collected or published unless doing so is essential for scientific purposes, and no identifiable information (including names, initials, or images) will appear in any reports, publications, or supplementary materials. Participants have also been informed that they may withdraw from the study at any time without any effect on their access to routine health services. Ethics approval was granted by the Ministry of Health, Brunei Darussalam Medical and Health Research Ethics Committee (MHREC/MOH/2024/111).

With the rising prevalence of diabetes in Southeast Asia, organizations such as the International Diabetes Federation are increasing efforts in diabetes advocacy and exploring new ways to improve access to quality health care and affordable treatments. Patient empowerment by incorporating self-management represents an important component of diabetes care, which will improve health outcomes and reduce diabetes-related complications. Therefore, new interventions should be designed with a focus on incorporating the latest clinical guidelines with an all-encompassing program that includes monitoring, diabetes education, maintaining a healthy lifestyle through diet and physical activity, medication tracking, and motivational coaching. A reduction of 1% in HbA_1c levels over 3 months is associated with decreased mortality and a reduction in microvascular disease, while a reduction in weight has been shown to improve glycemic control and insulin sensitivity, and potentially reduce medication dosage [21,22]. Consequently, an effective program would focus on methods to improve key cardiovascular risk factors, such as a reduction in HbA_1c and weight.

The increasing digitalization in the health care landscape has led to the deployment of mHealth and digital interventions to guide self-management of chronic conditions, particularly in diabetes management. Diabetes management apps can supplement traditional face-to-face care. This will help reduce the time and resources required from the health care system. Patients who have better self-management practices tend to manage their condition better [9]. By allowing users to actively participate in their own health management, users can increase their health literacy and become more confident in navigating their condition. However, an issue faced by most diabetes management apps is low engagement, with many users lost to follow-up [23]. A study showed that users were less likely to engage due to the high effort and difficulty in using the apps [24]. Therefore, collecting feedback on participant experience is crucial to identify functions and protocols that need to be redesigned to create an app that enhances the patient experience and level of engagement.

Due to the global burden of diabetes, various apps for diabetes management are commercially available on the market [25]. The main functionalities offered include self-management tasks (medication, blood glucose monitoring, exercise, and food intake), weight and blood pressure tracking, and education [26]. Most apps cover at least 1 self-management task, with blood glucose monitoring being the most common function [26]. According to the research that has been conducted to assess the efficacy of these apps, diabetes self-management apps have demonstrated a significant reduction in HbA_1c and body weight after a 6-month follow-up [9,27]. Most of these apps are free to download, with premium functions that require additional fees. The average cost of diabetes management apps on the market is between US $4.57 and US $5.03, with a higher annual cost for apps with multiple functions, making mHealth a cost-effective solution focused on preventing disease progression [28].

DM DTx is the first digital intervention solution of its kind in Southeast Asia. Most diabetes mHealth solutions are targeted at the North American market as part of an annual subscription plan usually provided by employers. This is largely attributed to the increasing penetration of smart consumer devices and the higher acceptance of mHealth solutions in the region [28]. Additional research on the efficacy of diabetes self-management apps in Southeast Asia should be conducted, as recommendations from solutions on the market may not be suitable in Southeast Asia due to different cutoff ranges for clinical parameters and cultural differences. Lifestyle habits and user behavior may also differ vastly between different populations, solidifying the need for region-specific intervention designs. Most commercially available diabetes management apps showed only low-to-moderate success in terms of user adherence, proving that diabetes self-management solutions do not follow a one-size-fits-all approach.

This study possesses some limitations. First, the study is designed based on volunteer sampling. Ideally, the study should be designed as a randomized controlled trial to reduce selection bias and ensure that the results are generalizable to a broader population. Any observable effects cannot be conclusively attributed to the intervention due to the lack of a control group. Sampling is done within the Bruneian population, so the results may not apply to populations outside of the current demographic. As the participants are not followed long-term, there is a lack of understanding of the sustained effects and durability of the intervention over time. Participants’ readiness to change their lifestyle habits was also not measured, as it was assumed that their participation translated to readiness. Finally, participants’ digital literacy is not measured during recruitment, which may affect their participation in the digital intervention and lead to less optimal results due to external barriers.

Self-management mHealth apps remain a promising adjunct to chronic disease care, especially in T2DM. However, the impact of these apps in improving health is greatly dependent on localization to a region’s clinical and cultural context. Through data-driven research, gaps in intervention and app design can be identified to bridge the gap between theorized and realized improvements in health outcomes.

Ultimately, this research aims to understand the efficacy of DM DTx to develop a solution that is fit for purpose, clinically sound, patient-centered, and sufficiently personalized.