Development and Exploration of the Effectiveness and Feasibility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD): Protocol for a Clinical Nonrandomized Pilot Trial in Brunei Darussalam

Hiu Nam Chan, Hong Shen Lim, Pui Lin Chong, Chee Kwang Yung, Musjarena Abd Mulok, Yuan Wei, Alice Moi Ling Yong, Hiu Nam Chan, Hong Shen Lim, Pui Lin Chong, Chee Kwang Yung, Musjarena Abd Mulok, Yuan Wei, Alice Moi Ling Yong

Abstract

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://ichgcp.net/clinical-trials-registry/NCT05364476.

International registered report identifier (irrid): DERR1-10.2196/43208.

Keywords: DEsireD; EMR; chronic disease management; digital intervention; health coaching; mHealth; type 2 diabetes mellitus; value-based care.

Conflict of interest statement

Conflicts of Interest: HNC, HSL, and YW are full-time employees of EVYD Technology Limited. EVYD Technology Limited is the technology partner and research collaborator of this study. EVYD Technology Limited is the developer of the T2DM digital therapeutics application EVYDResearch and BruHealth mobile app used in this study. The authors declare that there is no other conflict of interest.

©Hiu Nam Chan, Hong Shen Lim, Pui Lin Chong, Chee Kwang Yung, Musjarena Abd Mulok, Yuan Wei, Alice Moi Ling Yong. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 07.12.2022.

Figures

Figure 1
Figure 1
The DEsireD pilot trial study protocol. Bru-HIMS: Brunei Darussalam Healthcare Information and Management System; DEsireD: Development and Exploration of the Effectiveness and Feasibility of a Digital Intervention for Type 2 Diabetes Mellitus.
Figure 2
Figure 2
Push notification via the national health care app (BruHealth) for the Development and Exploration of the Effectiveness and Feasibility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD) study recruitment.
Figure 3
Figure 3
Video consultation appointment arranged via BruHealth app.
Figure 4
Figure 4
Video consultation interphase via the national health care app (BruHealth).

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