Prospective Study, Insulin Pump-RT Advisor (IPRA©): a Decision Support Software for Diabetic Patients Treated by Insulin Pump and Using Continuous Glucose Monitoring. Experimental Study. Evaluation by an Expert Patient Panel.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Patient agreement with the IPRA© advices: global rate of agreement, according to advice subtypes, according to blood glucose levels, according to the situations (pre or post-meal, bedtime)
研究概览
简要总结
The purpose of the study is to assess the relevance of the advices provided by the IPRA© smartphone application for guiding the responses of insulin pump treated type 1 diabetes patients using real-time continuous glucose monitoring.
详细描述
Patients will be asked to evaluate the IPRA advices by connecting to IPRA© application by using their smartphone, 30 times a week for two weeks. At the end of this two week period, a satisfaction questionnaire will be completed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women ≥ 18 years of age,
- •patients with type 1 diabetes for more than 2 years,
- •patients treated by insulin pump for more than 6 months,
- •patients using of real-time continuous glucose monitoring for more than 3 months,
- •patients able to evaluate the IPRA advices by connecting to IPRA© application 30 times a week,
- •patient able to provide written informed consent,
- •patient able to provide written non-disclosure agreement
排除标准
- •pregnancy or breastfeeding,
- •current infectious disease,
- •patients with no smartphone® or Internet access,
- •adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty
结局指标
主要结局
Patient agreement with the IPRA© advices: global rate of agreement, according to advice subtypes, according to blood glucose levels, according to the situations (pre or post-meal, bedtime)
时间窗: 3 months
Assessment of the relevance of the advices provided by the IPRA© smartphone application for guiding the responses of insulin pump treated type 1 diabetes patients using real-time continuous glucose monitoring.
次要结局
- Assessment of patient satisfaction(3 months)
- Assessment of similarity between patient decisions and IPRA© advices(3 months)
- Assessment of changes proposed by the experts(3 months)
- Assessment of frequency of software use(3 months)