Chan Hiu Nam, Lim Hong Shen, Chong Pui Lin, Yung Chee Kwang, Abd Mulok Musjarena, Wei Yuan, Yong Alice Moi Ling
EVYD Research Pte Ltd, Singapore, Singapore.
Endocrine Centre, Raja Isteri Pengiran Anak Saleha Hospital, Ministry of Health, Bandar Seri Begawan, Brunei Darussalam.
JMIR Res Protoc. 2022 Dec 7;11(12):e43208. doi: 10.2196/43208.
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.
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 A (HbA) reduction of at least 0.6% from baseline, and the secondary outcomes include a change in HbA, BMI, lipid profile, and EQ-5D-5L score.
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.
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.
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.
ClinicalTrials.gov NCT05364476; https://clinicaltrials.gov/ct2/show/NCT05364476.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43208.
2型糖尿病（T2DM）在全球的患病率正在上升。结合使用手机和可穿戴设备的数字干预措施越来越受欢迎。数字干预与专业管理支持相结合，比单纯的数字干预更能提高用户的自我效能，并为生活方式干预提供更好的可及性。然而，在穆斯林占多数的国家，探索应用数字干预措施的可行性和有效性的研究有限，文莱达鲁萨兰国尚未开展此类研究。
本研究旨在确定一项为期16周的T2DM自我管理数字干预计划的有效性和可行性，并指导一款移动应用程序的推出，作为文莱成年T2DM患者群体健康解决方案的一部分。本研究的主要结局是测量血红蛋白A（HbA）较基线降低至少0.6%的参与者比例，次要结局包括HbA、体重指数（BMI）、血脂谱和EQ-5D-5L评分的变化。
这项单臂非随机试点研究将采用基于网络（使用国家医疗保健应用程序[BruHealth]和官方社交媒体平台进行宣传）和线下（在健康中心进行面对面招募）的方法招募参与者。180名年龄在20至70岁之间、符合纳入标准的T2DM患者将参加为期16周的数字干预计划。将评估基线和干预后的指标。
该研究获得了文莱达鲁萨兰国卫生部医学与健康研究及伦理委员会（MHREC/MOH/2022/4(1)）的批准。招募过程正在进行中，我们预计该研究将于2023年4月结束。随后将进行数据分析和结果报告，并计划发表。本研究的结果将通过科学出版物和会议进行传播。如果在文莱被证明是一种有效且可行的方法，本研究将为启动T2DM数字治疗计划提供指导，并扩展到其他非传染性疾病（NCD）。
2型糖尿病数字干预有效性和可行性的开发与探索（DEsireD）研究将是第一项调查为穆斯林占多数的国家文莱量身定制的为期16周T2DM数字干预计划的临床有效性和可行性的研究。本研究的结果可能会将提议的护理模式推广到其他非传染性疾病，作为国家健康管理解决方案的一种方法。
ClinicalTrials.gov NCT05364476；https://clinicaltrials.gov/ct2/show/NCT05364476。
国际注册报告标识符（IRRID）：DERR1-10.2196/43208。
