CUTADIAB OBSERVATORY Investigation of the Skin Manifestations Associated With the Adhesives of Technological Tools for Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 851
- 试验地点
- 4
- 主要终点
- Percentage of skin intolerance to adhesives in diabetic patients
研究概览
简要总结
The use of technological tools in the treatment of diabetes has intensified and become common in recent years. Many of these systems adhere to the skin with an adhesive in place between 2 and 14 days. The objective of this study is to determine the prevalence and consequences of skin reactions to skin adhesive systems for the treatment of diabetes.
详细描述
The use of technological tools in the treatment of diabetes has intensified and become common in recent years. Many of these systems adhere to the skin with an adhesive in place for between 2 and 14 days, or even longer, depending on the system under consideration. Unfortunately, an increase in skin reactions has been observed in diabetic patients using these new technologies, sometimes leading to discontinuation. The number of studies evaluating the cutaneous tolerance of the patches used by these technologies is limited, so the prevalence of these skin intolerances is unknown.
The objective of this study is to determine the prevalence and consequences of skin reactions to skin adhesive systems for the treatment of diabetes. It will be implemented with the following design:
- observational, cross-sectional, multicentre study involving 4 Diabetology centres and over a period of 6 months.
- Establishment of an observatory on skin reactions to FreeStyle Libre® (FSL) and all other adhesive systems related to new technologies for the treatment of diabetes
- A questionnaire will be systematically proposed to the patients concerned, during the usual diabetes follow-up consultations made by all investigators.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Adult (≥ 18 years old)
- •All types diabetes (1, 2, other)
- •Any patient who wears or has worn an adhesive system for the treatment of diabetes (insulin pump, and/or continuous glucose monitoring system) within the last 10 years.
- •Seen consecutively in consultation
- •Patient who was informed on the research and are not opposed to participation.
排除标准
- •Illiteracy
- •Refusal to participate in the study (refusals will be counted)
- •Patient under guardianship or curatorship
结局指标
主要结局
Percentage of skin intolerance to adhesives in diabetic patients
时间窗: Single visit at day 0
Percentage of skin intolerance in diabetic patients - all types of diabetes - using or having used in the last 10 years adhesive systems integrated into diabetes medical devices: patch insulin pump, pump with externalized catheter or continuous glucose measurement system.
次要结局
- Consequences of skin reactions(Single visit at day 0)
- Prevalence of skin reactions by adhesive system(Single visit at day 0)
- Semiological description of skin lesions(Single visit at day 0)
- Percentage of positive responses to the question concerning patient approaches to avoid skin reaction(Single visit at day 0)
- Percentage of positive responses to the question concerning the delay of appearance of skin manifestation(Single visit at day 0)
- Evolution of lesions(Single visit at day 0)