Scaling up Personalized mHealth-supported Resistance Training and Education for Children and Adolescents With Type 1 Diabetes: The Diactive-1 v2.0 Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Change in handgrip strength
研究概览
简要总结
The Diactive-1 project aims to establish the Diactive-1 mobile application as a clinical tool for managing type 1 diabetes in children and adolescents in several hospitals from Spain. The successful implementation of the app in new healthcare centers nationwide represents a key step toward the development of a comprehensive and scalable program. This approach seeks not only to optimize current patient care but also to democratize access to an innovative, evidence-based intervention that supports daily diabetes management.
In this new phase, the project will integrate the application into routine clinical care for patients with type 1 diabetes through the use of a simple handgrip strength measurement. A dedicated web platform (www.diactive.es) is being developed to allow clinicians to enter basic patient data, including handgrip strength, sex, and email address. Based on this information, the system will automatically generate a personalized download link for the Diactive-1 app, accompanied by tailored guidance and an initial fitness level classification (low, medium, or high) according to European reference values.
This process will define each user's baseline fitness level and facilitate the use of Diactive-1 as an integrated and individualized disease management tool. The ultimate goal is to strengthen clinical decision-making, improve patient engagement, and extend the benefits of digital health to a broader pediatric population living with type 1 diabetes.
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
- Single (Investigator)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Type 1 Diabetes Mellitus (T1DM) for 6 months or longer (requiring >0.5 U/kg/day of insulin and having HbA1c >6%, i.e., not in the "honeymoon phase").
- •Receiving multiple daily injection (MDI) therapy or insulin pump therapy (CSII).
- •Signed informed consent authorizing legal participation in the research project (child/adolescent and parent(s)/legal guardian).
- •Availability to participate in the study using an m-Health application (Diactive-1) designed for the programming of muscle-bone strengthening physical exercise.
- •Understanding of Spanish.
排除标准
- •Comorbidities that limit the ability to engage in physical activity.
- •Lack of internet access when using the application, whether due to Wi-Fi, mobile data, or international roaming issues.
- •Absence of a mobile phone or tablet with an Android or iOS (Apple) operating system, or no family member willing to lend a device for each session using the application for study-related purposes.
结局指标
主要结局
Change in handgrip strength
时间窗: Baseline and 12 weeks
Handgrip strength measured in kilograms using the Takei III Smedley Type Digital Dynamometer
次要结局
- Change in daily insulin dose requirement(Baseline and 12 weeks)
- Change in glycated hemoglobin(Baseline and 12 weeks)
- Number of participants with good glycemic control(Baseline and 12 weeks)
- Change in time in range(Baseline and 12 weeks)
- Change in time below range(Baseline and 12 weeks)
- Change in time above range(Baseline and 12 weeks)
- Change in glycemic variability(Baseline and 12 weeks)
- Change in compliance with 24-hour movement behaviors(Baseline and 12 weeks)
- Change in self-reported physical activity(Baseline and 12 weeks)
- Change in self-reported physical fitness(Baseline and 12 weeks)
- Change in sleep duration(Baseline and 12 weeks)
- Change in physical literacy(Baseline and 12 weeks)
- Change in physical activity barriers(Baseline and 12 weeks)
- Adherence to the Mediterranean Diet(Baseline and 12 weeks)
- Change in disordered eating(Baseline and 12 weeks)
- Change in subjective well-being(Baseline and 12 weeks)
- Change in Health-Related Quality of Life(Baseline and 12 weeks)
- Change in Health-Related Quality of Life in the context of a chronic illness(Baseline 12 weeks)
- Change in microalbuminuria(Baseline and 12 weeks)
- Change in retinal findings(Baseline and 12 weeks)
- Change in body mass index(Baseline and 12 weeks)
- App usability: user(12 weeks)
- App usability: expert evaluation(12 weeks)