NCT04161651Unknown不适用
Evaluation of Long-Term Implanted Sensor in Patients on Quality of Life
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 22
- 主要终点
- changes in quality of life evaluated questionnaires (DTSQ)
研究概览
简要总结
Evaluation of Long-Term Implanted Sensor in Patients on Quality of life
详细描述
Assess satisfaction and acceptance of long-term implanted single sensor use (eversense XL) for up to 6 months in type 1 insulin-using patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male or Female diagnosed with type 1 diabetes mellitus
- •Insulin treatment for at least 1 year (Either MDI of CSII)
- •HbA1c < 11%
- •Signing informed consent and willing to apply with study procedure
排除标准
- •History of severe hypoglycaemia in the last 3 months
- •History of DKA in the last 3 months
- •Any condition preventing or complicating the placement, operation or removal of the Sensor including upper extremity deformities or skin condition
- •Female subjects of childbearing capacity (defined as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study
- •Any condition that require MRI imaging or planned MRI during the trial period
- •Known topical or local anaesthetic allergy
- •Known allergy to glucocorticoids
- •History of hepatitis B, hepatitis C or HIV
- •Any Bleeding disorder or taking anticoagulant medication
- •Participation in other clinical trial
- •Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
研究组 & 干预措施
single arm
Experimental
干预措施: eversense (Device)
结局指标
主要结局
changes in quality of life evaluated questionnaires (DTSQ)
时间窗: 6 months
次要结局
- Change in HBA1C(3 / 6 months)
- CGM Time In Range (70-180 mg/dl)(3 / 6 months)
- CGM Time in hypoglycaemia below 70 mg/dl(3 / 6 months)
- CGM Time in hypoglycaemia below 54 mg/dl(3 / 6 months)
- CGM time in range difference [2 weeks before digital visit and 2 weeks after digital visit](3 / 6 months)
- Change in HFS-ii (hypoglycaemia fear survey II)(6 months)
- Change in Continuous Glucose Monitor Satisfaction Scale (CGM-SAT)(6 months)
- Any adverse event related to study device(6 months)
研究者
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