Background The prevalence of type 2 diabetes mellitus (T2DM) is increasing worldwide. Digital interventions that incorporate the use of mobile phones and wearables have been getting popular. A combination of a digital intervention with support from professional management can enhance users’ self-efficacy better than a digital intervention alone and provide better accessibility to a lifestyle intervention. However, there are limited studies exploring the feasibility and efficacy of applying a digital intervention in Muslim-majority countries, and none have been conducted in Brunei Darussalam. Objective The study aims to determine the effectiveness and feasibility of a proposed 16-week digital intervention program for T2DM self-management and to guide the rollout of a mobile app as part of a population health solution for adults with T2DM in Brunei. The primary outcome of this study is to measure the proportion of participants with a hemoglobin A1c (HbA1c) reduction of at least 0.6% from baseline, and the secondary outcomes include a change in HbA1c, BMI, lipid profile, and EQ-5D-5L score. Methods This single-arm nonrandomized pilot study will recruit participants using web-based (with the national health care app [BruHealth] and official social media platforms being used for outreach) and offline (in-person recruitment at health centers) approaches. A target of 180 individuals with T2DM aged between 20 and 70 years that meet the inclusion criteria will be enrolled in a 16-week digital intervention program. Baseline and postintervention markers will be evaluated. Results The study received approval from the Medical and Health Research & Ethics Committee of the Brunei Darussalam Ministry of Health (MHREC/MOH/2022/4(1)). The recruitment process is ongoing, and we anticipate that the study will conclude by April 2023. This will be followed by data analysis and the reporting of outcomes with the intention to publish. The results of this study will be disseminated through scientific publications and conferences. This study will serve as a guide to launch T2DM digital therapeutic programs and extend to other noncommunicable diseases (NCDs) if proven as an effective and feasible approach in Brunei. Conclusions The Development and Exploration of the Effectiveness and Feasibility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD) study will be the first study to investigate the clinical effectiveness and feasibility of the proposed 16-week T2DM digital intervention program tailored for Brunei, a Muslim-majority country. The findings of this study can potentially scale up the proposed model of care to other NCDs as a national approach for health management solutions. Trial Registration ClinicalTrials.gov NCT05364476; https://clinicaltrials.gov/ct2/show/NCT05364476 International Registered Report Identifier (IRRID) DERR1-10.2196/43208

BACKGROUND The prevalence of type 2 diabetes mellitus (T2DM) is increasing worldwide, and the estimated prevalence is 12.4% amongst the 20-75 years old group in Brunei Darussalam. Digital intervention has been shown to be cost-effective in the management of T2DM and provide a better accessibility of lifestyle intervention. A combination of digital intervention with support by professional management can enhance users with better self-efficacy than digital intervention alone. OBJECTIVE The study aims to determine the potential effectiveness and feasibility of the proposed 16-week digital intervention programme for T2DM self-management, and to guide the roll out of a mobile application (APP) as part of the population health solution for adults with T2DM in Brunei Darussalam. The primary outcome of this study is to measure the proportion of participants with HbA1c reduction of at least 0.6% from baseline; and the secondary outcomes include a change in 1) HbA1c, 2) body mass index, 3) lipid profile and 4) EQ-5D-5L. METHODS This single-arm, non-randomised pilot study includes 1) participant recruitment in an online [leverage on the national healthcare information and management system to select eligible individuals, national healthcare APP (BruHealth) and official social media platforms for outreach] and offline manner (in-person recruitment at health centres), 2) selection of 180 individuals with T2DM aged between 20 and 70 years who fulfill the study inclusion criteria with baseline data collection at offline health centres, followed by enrolment into a 16-week digital intervention programme which consists of online and offline support, 3) evaluation of relevant markers post-intervention (state markers being measured). RESULTS The study started in April 2022. It has received approval by the Medical and Health Research and Ethics Committee of the Brunei Ministry of Health (MHREC/MOH/2022/4(1)). This pilot study is still ongoing and preliminary results will be available by November 2022. CONCLUSIONS The conclusions will be able to provide evidence to prove the effectiveness of the developed 16-week digital intervention programme for T2DM management, feasibility of the proposed model of care and as a guide to roll out an APP as a digital solution in Brunei Darussalam with the intention to optimise the quality of life for individuals with T2DM. CLINICALTRIAL ClinicalTrials.gov NCT05364476