Data Driven Feedback as a Method to Improve Glycaemic Control in Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in the Frequency of Hyper- and Hypo-glycemic Events From Baseline to Week 8-12.
研究概览
简要总结
Patients with Diabetes Mellitus Type 1 using electronic self-help tools typically registers a large amount of data on their disease. The study intends to see if giving advanced feedback on these data can improve their blood glucose management.
详细描述
All patients will be given access to a mobile phone with the diabetes diary known as the Few Touch Application (FTA) installed. They may use either their own compatible Android handsets, or provided handsets. The study uses a delayed start design. Participants are randomized into two groups, who get access to the module "Diastat" after 4 and 12 weeks post-enrollment respectively. Each group uses the FTA with Diastat for 8 weeks post-intervention (i.e. access to Diastat).
Diastat is a module within FTA that provides data-driven feedback to the patients using their own data. This module is based on the data recorded in a previous trial [1]. Three submodules are part of Diastat; Periodicity detection and visualization, multiscale trend detection based on the c-SiZer algorithm [2], and situation matching for insulin dosage [3].
- Skrøvseth SO et al, Diabetes Technol Ther (2012)
- Skrøvseth SO et al, PLoS ONE (2012)
- Skrøvseth SO et al, Accepted for Advanced Technologies and Treatments for Diabetes, Paris, France, 2013.
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
- •Confirmed diagnosis with Diabetes Mellitus type 1 for at least one year.
- •Age over 18 years
- •Has basic familiarity with mobile phones, and uses mobile phone on a daily basis.
排除标准
- •Severe complications due to their diabetes.
- •Unable to understand or conform to the guidelines when presented with the phone's software.
结局指标
主要结局
Change in the Frequency of Hyper- and Hypo-glycemic Events From Baseline to Week 8-12.
时间窗: Up to 12 weeks post-enrollment
The number of self-measured blood glucose values \< 4 mmol/L (72 mg/dL) or \> 15 mmol/L (270 mg/dL) will be recorded during baseline (first 4 weeks post-enrollment/start of study) and during weeks 8-12 post-enrollment for all participants.
次要结局
- Change in HbA1c(up to 20 weeks post-enrollment)