Evaluation of Different Types of Adhesive Materials for Continuous Glucose Monitoring Systems in Subjects With Type 1 and Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Survival rate
研究概览
简要总结
Within the present study 4 different band-aid/adhesive combinations will be tested in patients with type 1 diabetes and type 2 diabetes with regard to adherence to the body and allergic potential. The study period is set to 21 days following adhesive material placement to cover the maximum expected wear-time of the novel CGM system (14 days) plus an additional seven days to ensure that adhesive material is tested for a sufficient time-period and differences in adhesion can clearly be observed.
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
- •Informed consent obtained after being advised of the nature of the study
- •Male or female aged ≥18 years
- •Type 1 diabetes for at least 6 months according to the WHO definition or Type 2 diabetes for at least 6 months according to the WHO definition
- •Body Mass Index (BMI) <45 kg/m²
- •Willing and able to wear 4 different band-aid/adhesive materials for the duration of the study and undergo all study procedures
- •HbA1c ≤86 mmol/mol
排除标准
- •Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
- •Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
- •Any mental condition rendering the subject incapable of giving his consent
- •Subject is using any medication that significantly impacts immune response (oral steroids)
- •Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
- •Subject is actively enrolled in another clinical trial
- •Known severe hypersensitivity to adhesive or skin lesions that hinder band-aid application
- •Inability of the subject to comply with all study procedures
- •Inability of the subject to understand the subject information
- •Has children two years of age or younger
- •Vulnerable patients, patients deprived from liberty and patients with a physical or mental state altered by disease, age or disability which impacts their ability to defend their interests and for which protection measures are taken ("protected majors" as per French law).
研究组 & 干预措施
CGM patch
Patient receives four models of CGM patches. Adhesion sites are randomly allocated (1 on each upper arm, 2 on the abdomen).
干预措施: CGM patch (Device)
结局指标
主要结局
Survival rate
时间窗: 21 days
14 days survival rate of different models of CGM patches to fixate a CGM sensor system.
次要结局
- Attachment site reactions(21 days)
- Survival time(21 days)