NCT06028139招募中不适用
Continuous Assessment of Risk and Efficacy (CARE) Using Health Coaching, Continuous Glucose Monitoring and AI Mobile App in Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- HbA1c
研究概览
简要总结
Lifestyle change is key to diabetes management but there are limited resources and time to support patients in improving lifestyle behaviour in the current healthcare system. Currently, health coaching for behavioural chance guided by continuous glucose data, wearable and lifestyle data is not available in primary and tertiary care management of diabetes. This parallel-group randomised controlled trial (RCT) aims to investigate the effectiveness of a novel multi-component model of care comprising interventions including the mobile app EMPOWER and smartwatch, health coaching, and continuous glucose monitoring (CGM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 21 years and above
- •Have diagnosis of type 2 diabetes mellitus
- •Provided informed consent
- •Have near-field communication (NFC) compatible phones
- •Able to engage in light physical activity (e.g., walking)
排除标准
- •Significant cognitive impairment
- •Other conditions that may preclude participants from wearing CGM devices
结局指标
主要结局
HbA1c
时间窗: 6 months
HbA1c over 6 months
次要结局
- Physical activity as measured by GPAQ(6 months)
- Sugar sweetened beverages intake(6 months)
- Quality of life as measured by EQ-5D-5L(6 months)
- Patient activation score as measured by patient activation measure(6 months)
- Healthcare cost as measured by cost of consultations, lab tests, medications, admission(6 months)
- Medication adherence as measured by DOSE-Nonadherence scale(6 months)
- Physical activity as measured by number of steps(6 months)
- Physical activity as measured by moderate to vigorous active minutes(6 months)
- Diet as measured by DASH(6 months)
- Healthcare cost as measured by WPAI(6 months)
研究者
研究点 (4)
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