NCT04739124已完成不适用
Appropriation of the Connected Solution Freestyle Libre® in Adult Patients With Diabetes in the Context of Therapeutic Education
Direction Centrale du Service de Santé des Armées2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2021年6月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Correlation between appropriation factors, intention to use, Freestyle Libre use and glycemic control
研究概览
简要总结
Following the proposal to self-monitor by the Freestyle Libre® (FSL) connected object, in diabetic patients in the context of therapeutic education, regarding the appropriation of FSL, what works, for which patients , in what specific contexts and by what mechanisms does it govern? A multicentric observational research will be conducted with mixed method design (follow-up using patient questionnaires) and semi-structured interviews of patients and caregivers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have type 1 or type 2 diabetes (as included in the education program),
- •Be of legal age (over 18 years old),
- •Do not present legal protection measures due to incapacity (such as guardianship or guardianship).
- •Be able to read and speak French (elementary school level)
- •Be eligible for FSL prescription and authorize the sharing of your data in Libreview®
- •Be affiliated to a social security scheme
- •Have an email address or a phone allowing internet use
- •Caregivers
- •Be registered on the roll of his professional order
- •Hold the certificate of 40 hours of training in therapeutic education.
- •Practice therapeutic education on a regular basis
排除标准
- •presenting contraindications to the use of Freestyle Libre® (known allergies to adhesive products, coagulation disorders, not treated with insulin therapy or with less than 3 insulin injections per day or continuously, not requiring glycemic monitoring or less than 3 times a day)
- •Patient refusing to follow the education program,
- •Minors, patients under administrative or judicial supervision)
- •Pregnant women,
- •Patients who cannot be contacted in an emergency,
- •Persons in a position to give their consent but with an inability to read / write the French language.
- •Patients who do not have an email address or a phone allowing internet use.
- •Caregivers
- •Failure to register with the professional order (except those of the Army Health Service who are exempt)
- •Non-possession of the 40-hour therapeutic education training certificate.
- •Not practicing FSL education
结局指标
主要结局
Correlation between appropriation factors, intention to use, Freestyle Libre use and glycemic control
时间窗: 3 months
longitudinal multifactor analysis by structural equation modeling of the research model created specifically
次要结局
未报告次要终点
研究者
研究点 (2)
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