Proof-of-concept Study for the Integration of Physical Activity Into the Clinical Decision Process of Physically Active People with Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Database which contains insulin data (insulin dose over time) retrieved from diabetes management platforms.
研究概览
简要总结
Every person with type 1 diabetes needs personalized advice to integrate physical activity into daily diabetes management. The purpose of this study is to collect data on food intake, physical activity, glucose levels and insulin delivery from people with type 1 diabetes who are physically active. At least 25 people with type 1 diabetes will be asked to perform 25 sports activities of at least half an hour, wear an activity tracker (day and night) and chest strap (during sports activities), and log data on food intake, periods and type of physical activity, and feelings (e.g., sick, stress) in a diary app. Diabetes data such as insulin administration and sensor data will be collected through diabetes management platforms. The primary endpoint involves a database containing data on glucose, insulin administration, physical activity, and food intake of people with type 1 diabetes for statistical analyses and visualizations regarding the relationship between physical activity and blood glucose response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •18-80 years old
- •Type 1 diabetes ≥1 year
- •Using a CGM for more than 6 months
- •Using insulin (insulin pens, insulin pumps or hybrid closed-loop systems) to manage glycaemia for more than 6 months
- •No use of adjunctive therapies, such as SGLT2-inhibitors or GLP-1 analogues
- •No known diabetic gastroparesis
- •HbA1c of the last two diabetes consultations are both <10%
- •Being physically active at least twice a week on two separate days for 30 consecutive minutes
排除标准
- •Age <18 years or >80 years
- •People with type 2 diabetes, people with secondary diabetes
- •Begin treatment with insulin (insulin pens, insulin pumps or hybrid closed-loop systems) less than 6 months before inclusion
- •Not using CGM prior to inclusion
- •Known diabetic gastroparesis
- •HbA1c > 10% during one of the last two diabetes consultations
- •Not willing to use an activity tracker, the diary app or the food app
- •Not being physically active on a regular basis
结局指标
主要结局
Database which contains insulin data (insulin dose over time) retrieved from diabetes management platforms.
时间窗: Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains physical activity data (intensity of activity) retrieved from the activity tracker and chest strap.
时间窗: Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains food intake data (timing of food) retrieved from the diary app.
时间窗: Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains glucose data (glycemic values over time) retrieved from diabetes management platforms.
时间窗: Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains food intake data (amount of food in grams) retrieved from the diary app.
时间窗: Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains physical activity data (type of activity) retrieved from the activity tracker and chest strap.
时间窗: Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains physical activity data (duration of activity) retrieved from the activity tracker and chest strap.
时间窗: Through study completion (after 25 sport activities), an average of 6 weeks
Database which contains food intake data (type of food) retrieved from the diary app.
时间窗: Through study completion (after 25 sport activities), an average of 6 weeks
次要结局
未报告次要终点
研究者
prof dr Pieter Gillard
Principal investigator
Universitaire Ziekenhuizen KU Leuven