"An Online Personalised Lifestyle Program With a Virtual AI Lifestyle Coach in Combination With Continues Glucose Monitoring for People With Type 2 Diabetes."
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
研究概览
简要总结
The aim of this study is to evaluate the feasibility and effectiveness of a remote personalised lifestyle program in individuals with T2D. Outcomes will be assessed at the start and after 3, 6, and 12 months with two follow-up measurements (18 and 24 months) to determine whether participation in this re-mote lifestyle program leads to improvements in health and diabetes-related outcomes.
详细描述
Rationale: An estimated 400,000 individuals in the Netherlands are living with undiagnosed type 2 diabetes (T2D), in addition to 1.1 million diagnosed cases. Unhealthy lifestyle behaviours are a major contributing factor. Intensive lifestyle interventions and Continuous Glucose Monitoring (CGM) have demonstrated effectiveness in improving health behaviour and glycaemic control. Digital health technologies, including personalised digital interventions and virtual coaching enable continuous, scalable and context-specific support, thereby facilitating sustained behaviour change and improved self-management. Remote lifestyle interventions are therefore promising and may enhance self-management and glycaemic control, reduce medicine use and delay the development of comorbidities and diabetes-related complications. This study evaluates a remote, personalised lifestyle program combining online group sessions, peer support, CGM use, and a virtual AI lifestyle coach for individuals living with T2D.
Objective: The objective of this study is to evaluate the added value of CGM, biofeedback and a virtual AI lifestyle coach providing personalised, data-driven support within a first prototype of a remote lifestyle intervention for adults with T2D. Specifically, this pilot randomized controlled trial aims to assess the incremental effects of CGM, biofeedback and AI supported personalised coaching, informed by glucose data, demographics, behaviour, goals and preferences on health behaviours and glycaemic control over a 12-month period with two follow-up measurements.
Study design: This three-arm parallel-group randomized controlled trial includes:
- A lifestyle program consisting of online group sessions and a peer support community.
- The same lifestyle program supplemented with a virtual AI lifestyle coach.
- The AI-supported program with four times CGM use.
Study population: Adults (n=160) with T2D (HbA1c ≥53 mmol/mol) without glucose lowering medication (except Metformin), both men and women from all ethnic backgrounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≥18 years
- •HbA1c: ≥53 mmol/mol (7 - 12%)
- •Signed informed consent form and willing to comply with the study procedures
- •Persons who are naïve for participation in a lifestyle program for the past two years
- •Being digitally competent
- •Mastering the Dutch language
- •Accepting the confidential use and storage of anonymised data for analysis and publication (at least 15 years)
排除标准
- •Medication use: any other glucose-lowering medication than metformin
- •Comorbidities or medical conditions requiring a special diet that conflicts with the study
- •Unstable body weight in the three months prior to inclusion in the study (±5% change based on body weight)
- •Circumstances that lead to unreliable HbA1c values, such as blood donation
- •Pregnant or lactating women
结局指标
主要结局
未指定
次要结局
- Change in blood pressure(From the beginning of the study to the end of the study (12 months))
- Study evaluation(Once at the end of the study at 12 months)
- Tailoring(Once at the end of the study at 12 months)
- Change in quality of life(At the start of the study and at the two follow-up measurements at 18 and 24 months)