JMIR Publications

ABSTRACT

Background:

Digital therapeutics may provide scalable support for type 2 diabetes mellitus (T2DM) management by integrating self-monitoring, structured education, behavioral support, and health coaching within digital health platforms. However, evidence on the effectiveness and implementation of such interventions at a national health system level remains limited.

Objective:

This study aimed to evaluate the effectiveness and user experience of the 16-week BALANCE Programme, a digital therapeutic intervention delivered through the BruHealth mobile application for adults with T2DM in Brunei Darussalam.

Methods:

This prospective, single-arm, open-label intervention study enrolled adults aged 18-70 years with T2DM. Participants received diabetes self-management education, personalized health coaching, self-monitoring tools, connected devices, lifestyle recommendations, and medication support through BruHealth. Clinical outcomes were assessed at baseline and 16 weeks. The primary outcome was the proportion of participants achieving an HbA1c reduction of at least 0.6%. Secondary outcomes included changes in HbA1c, fasting blood glucose, lipid parameters, body weight, body mass index (BMI), and waist circumference. Participant engagement, satisfaction, and factors associated with glycemic improvement were also evaluated.

Results:

Of 459 enrolled participants, 424 completed the 16-week intervention (92.4%). Among 360 participants with baseline and end of study HbA1c measurements, 205 (56.9%, 95% CI 51.8%-62.0%) achieved the predefined HbA1c reduction of at least 0.6%, while 298 (82.8%) demonstrated overall reduction in HbA1c. There were significant improvements in HbA1c (-1.0%, 95% CI −1.2 to −0.9; p<0.001), fasting blood glucose (-1.0 mmol/L, 95% CI −1.3 to −0.7; p <0.001), total cholesterol (-0.14 mmol/L, 95% CI −0.24 to −0.05; p=0.003), (-0.16 mmol/L, 95% CI −0.23 to −0.09; p<0.001), body weight (-2.4 kg, -2.8 to -2.0; p <0.001), BMI (-0.9 kg/m², 95% CI -1.1 to -0.8; p<0.001), and waist circumference (-5.2 cm, 95% CI -6.1 to -4.3; p 0.001). Suboptimal and poor baseline glycemic control, attendance at 5 video consultations, and achievement of the glucose logging target were associated with higher odds of achieving the HbA1c reduction threshold, whereas insulin treatment was associated with lower odds. The majority of participants were satisfied or very satisfied with the program (262/322, 81.4%), and would recommend it (313/317, 98.7%).

Conclusions:

The BALANCE Programme was associated with clinically meaningful improvements in glycemic control and multiple cardiometabolic outcomes, together with high completion and favorable participant feedback. These findings support the potential of digital therapeutics integrated into national health platforms as scalable adjuncts to conventional diabetes care. Controlled studies with longer follow-up are needed to confirm effectiveness and sustainability. Clinical Trial: ClinicalTrials.gov NCT06810986.