Endocrinology · Medical Literature
Evaluating the Impact and Practicality of a National Digital Intervention for Type 2 Diabetes Mellitus: Single-Arm Nonrandomized Pilot Trial.
Abstract
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 the accessibility and scalability of diabetes care. However, evidence regarding their effectiveness and feasibility in Southeast Asian populations remains limited. 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). 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 (VCs) and submitted self-monitoring records throughout the intervention period. Clinical outcomes included changes in HbA1c, fasting blood glucose, lipid profile parameters, BMI, waist circumference, and QoL measured using the EQ-5D-5L instrument. Feasibility outcomes included intervention completion, VC attendance, participant engagement, and intervention acceptability. A total of 122 participants were enrolled, and 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<.001). Overall, 65.4% (68/104) of participants achieved the predefined HbA1c reduction threshold of ≥0.6%, while 84.6% (88/104) demonstrated an overall reduction in HbA1c. Significant improvements were also observed in fasting blood glucose (-1.7 mmol/L, 95% CI -2.3 to -1.2; P<.001), BMI (-0.4 kg/m², 95% CI -0.6 to -0.2; P<.001), waist circumference (-1.9 cm, 95% CI -2.9 to -0.9; P<.001), total cholesterol (-0.3 mmol/L, 95% CI -0.6 to -0.2; P<.001), triglycerides (-0.5 mmol/L, 95% CI -0.7 to -0.2; P<.001), and EuroQol Visual Analog Scale (EQ-VAS) scores (+6.7 points, 95% CI 3.9 to 9.6; P<.001). The intervention demonstrated favorable feasibility outcomes, including an 88.5% (108/122) completion rate, attendance at ≥5 VCs by 75.9% (82/108) of participants, and high participant satisfaction, with 86.9% (86/99) of respondents reporting satisfaction or extreme satisfaction with the intervention. The pilot trial demonstrated 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 relevance
This pilot trial addresses a critical evidence gap regarding the feasibility and effectiveness of hybrid digital diabetes care models in Southeast Asian populations, where T2DM burden is substantial yet scalable intervention data are scarce. The study evaluates a nationally deployed program in Brunei Darussalam integrating remote coaching, structured digital education, and asynchronous WhatsApp-based communication over 16 weeks. Clinicians should note its implications for designing accessible, technology-augmented T2DM self-management programs in resource-constrained or geographically dispersed health systems.
Key findings
1. Among 104 participants with complete data, the hybrid digital intervention produced a mean HbA1c reduction of 1.2% (95% CI −1.45 to −0.96; P<.001) over 16 weeks, exceeding the predefined clinically meaningful threshold. 2. 65.4% (68/104) of participants achieved the primary endpoint of ≥0.6% HbA1c reduction, and 84.6% (88/104) demonstrated any reduction in HbA1c. 3. Fasting blood glucose improved significantly by −1.7 mmol/L (95% CI −2.3 to −1.2; P<.001). 4. Anthropometric outcomes improved, with BMI reduction of −0.4 kg/m² (95% CI −0.6 to −0.2; P<.001) and waist circumference reduction of −1.9 cm (95% CI −2.9 to −0.9; P<.001). 5. Lipid parameters improved significantly: total cholesterol −0.3 mmol/L (95% CI −0.6 to −0.2; P<.001) and triglycerides −0.5 mmol/L (95% CI −0.7 to −0.2; P<.001). 6. Health-related quality of life improved, with EQ-VAS scores increasing by +6.7 points (95% CI 3.9 to 9.6; P<.001); feasibility was strong, with an 88.5% (108/122) completion rate, 75.9% of completers attending ≥5 video consultations, and 86.9% of respondents reporting satisfaction or extreme satisfaction.
Practice implications
Endocrinologists and diabetes care teams should consider hybrid digital models—combining scheduled video consultations, structured remote education, and asynchronous messaging platforms—as a feasible adjunct to standard care for adults with T2DM, particularly in populations with limited access to frequent in-person visits. Patient selection should prioritize those capable of smartphone-based self-monitoring and asynchronous communication, given that high engagement (≥5 video consultations) was associated with strong program retention. Given the single-arm, non-randomized design and 16-week follow-up, these results should be interpreted as hypothesis-generating; larger randomized controlled trials with active comparators and longer follow-up are needed before widespread protocol adoption.