Evaluating the Impact and Practicality of a National Digital Intervention for Type 2 Diabetes Mellitus: Single-Arm Nonrandomized Pilot Trial.
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.
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.
Authors
Yong Yong, Chan Chan, Chong Chong, Yung Yung, Mulok Mulok, Musa Musa, Chan Chan, Lee Lee, Yusof Yusof, Chen Chen, Lim Lim
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