Table_1_EMPOWERing Patients With Diabetes Using Profiling and Targeted Feedbacks Delivered Through Smartphone App and Wearable (EMPOWER): Protocol for a Randomized Controlled Trial on Effectiveness and Implementation.docx

IntroductionType 2 diabetes mellitus (T2DM) poses huge burden and cost on the healthcare system. Mobile health (mHealth) interventions that incorporate wearables may be able to improve diabetes self-management. The aim of this randomized controlled trial (RCT) is to investigate the clinical and cost-effectiveness of personalized educational and behavioral interventions delivered through an EMPOWER mobile application (app) among patients with T2DM.
MethodsThis is a parallel two-arm randomized controlled trial (RCT). Patients with T2DM recruited from primary care will be randomly allocated in a 1:1 ratio to either intervention or control group. The intervention group will receive personalized educational and behavioral interventions through the EMPOWER app in addition to their usual clinical care. The control group will receive the usual clinical care for their T2DM but will not have access to the EMPOWER app. Our primary outcome is patient activation score at 12 months. Secondary outcomes will include HbA1c, physical activity level and diet throughout 12 months; quality of life (QoL), medication adherence, direct healthcare cost and indirect healthcare cost at 6 and 12 months.
DiscussionThis RCT will provide valuable insights into the effectiveness and implementation of personalized educational and behavioral interventions delivered through mobile application in T2DM management. Findings from this study can help to achieve sustainable and cost-effective behavioral change in patients with T2DM, and this can be potentially scaled to other chronic diseases such as hypertension and dyslipidemia.

引言
2型糖尿病（T2DM）给医疗保健系统带来了沉重的负担与高额成本。结合可穿戴设备的移动健康（mHealth）干预手段或可改善糖尿病自我管理。本项随机对照试验（RCT）旨在探究通过EMPOWER移动应用（app）实施的个性化教育与行为干预，在2型糖尿病患者中的临床有效性与成本效益。

方法
本研究为平行双组随机对照试验（RCT）。从基层医疗场景招募的2型糖尿病患者将以1:1的比例随机分配至干预组或对照组。干预组在接受常规临床诊疗的基础上，还将通过EMPOWER应用获取个性化教育与行为干预服务；对照组仅能获得2型糖尿病的常规临床诊疗，无法使用EMPOWER应用。本研究的主要结局指标为12个月时的患者激活评分。次要结局指标则包括12个月随访期间的糖化血红蛋白（HbA1c）、身体活动水平与饮食情况，以及6个月和12个月时的生活质量（QoL）、服药依从性、直接医疗成本与间接医疗成本。

讨论
本项随机对照试验将为移动应用介导的个性化教育与行为干预在2型糖尿病管理中的有效性及落地实践提供宝贵见解。本研究结果可助力2型糖尿病患者实现可持续且具备成本效益的行为改变，且该干预模式有望推广应用至高血压、血脂异常等其他慢性疾病的管理场景中。