Accepted for/Published in: JMIR Formative Research
Date Submitted: Mar 3, 2026
Open Peer Review Period: Mar 3, 2026 - Apr 21, 2026
Date Accepted: Jun 18, 2026
(closed for review but you can still tweet)
Evaluating The Impact And Practicality Of A National Digital Intervention For Type 2 Diabetes Mellitus: A Pilot Trial
ABSTRACT
Background:
Type 2 diabetes mellitus (T2DM) requires sustained self-management and lifestyle modification to achieve optimal glycemic control. Hybrid care models that combine digital health technologies with in-person clinical support may enhance patient engagement while improving accessibility and scalability of diabetes care. However, evidence regarding their effectiveness and feasibility in Southeast Asian populations remains limited.
Objective:
This study aimed to evaluate the preliminary effectiveness and feasibility of a national hybrid digital intervention for individuals with T2DM in Brunei Darussalam. The primary objective was to evaluate the proportion of participants achieving a reduction in glycated hemoglobin (HbA1c) of ≥0.6% after 16 weeks. Secondary objectives included evaluating changes in metabolic parameters, anthropometric outcomes, and health-related quality of life (QoL).
Methods:
This single-arm, nonrandomized pilot trial enrolled adults with T2DM into a 16-week hybrid digital intervention integrating remote health coaching, structured digital education, self-monitoring activities, and asynchronous communication via WhatsApp. Participants attended scheduled video consultations and submitted self-monitoring records throughout the intervention period. Clinical outcomes included changes in HbA1c, fasting blood glucose (FBG), lipid profile parameters, body mass index (BMI), waist circumference, and QoL measured using the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) instrument. Feasibility outcomes included intervention completion, video consultation attendance, participant engagement, and intervention acceptability.
Results:
A total of 122 participants were enrolled, 108 (88.5%) completed the intervention. Among 104 participants with complete HbA1c data, there was a mean reduction of 1.2% (95% CI −1.45 to −0.96; P<0.001). Overall, 68/104 participants (65.4%) achieved the predefined HbA1c reduction threshold of ≥0.6%, while 88/104 (84.6%) demonstrated an overall reduction in HbA1c. Significant improvements were also observed in FBG (−1.7 mmol/L, 95% CI −2.3 to −1.2; P<0.001), BMI (−0.4 kg/m², 95% CI −0.6 to −0.2; P<0.001), waist circumference (−1.9 cm, 95% CI −2.9 to −0.9; P<0.001), total cholesterol (−0.3 mmol/L, 95% CI −0.6 to −0.2; P<0.001), triglycerides (−0.5 mmol/L, 95% CI −0.7 to −0.2; P<0.001), and EQ-VAS scores (+6.7 points, 95% CI 3.9 to 9.6; P<0.001). The intervention demonstrated favorable feasibility outcomes, including an 88.5% completion rate, attendance of at least five video consultations among 82/108 participants (75.9%), and high participant satisfaction, with 86/99 respondents (86.9%) reporting satisfaction or extreme satisfaction with the intervention.
Conclusions:
The pilot trial demonstrates the acceptability, preliminary effectiveness and feasibility of a national hybrid digital intervention for individuals with T2DM in Brunei Darussalam. High completion rates, sustained participant engagement, and positive participant feedback support the practicality of implementation within a national digital health ecosystem. The intervention was also associated with improvements in glycemic control, metabolic outcomes, anthropometric measures, and health-related QoL. Larger controlled studies are warranted to evaluate long-term effectiveness, scalability, and implementation outcomes. Clinical Trial: Medical and Health Research and Ethics Committee (MHREC), Ministry of Health, Brunei Darussalam (MHREC/MOH/2022/4(1)). ClinicalTrials.gov NCT05364476; https://clinicaltrials.gov/study/NCT05364476 (registered on May 9, 2022).
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.