DRKS00028739已完成未知
A prospective, single arm, open-label, interventional, pivotal study to evaluate the efficacy and safety of the Continuous Glucose Monitoring System ‘CareSens Air’ in adult patients with type 1 and type 2 diabetes - IfDT-1936-IE
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- i-SENS, Inc.
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Patients with type 1 or type 2 diabetes who use intensive insulin therapy for at least 3 months
- •- Patients who voluntarily decided to participate in the study and provide written informed consent
排除标准
- •1. Potential subjects older than = 45 years with more than 2 further cardiovascular risk factors (see factors a-c below) will be excluded from study entry:
- •b.) Arterial hypertension (>140 / 90 mmHg)
- •c.) HbA1c > 9.0 %
- •2. Patients with the following abnormal skin or skin diseases or skin alterations at the CGM sensor attachment or insertion site
- •Severe psoriasis, recent burn injury or severe sunburn, severe eczema, severe scar, extensive tattoo, dermatitis herpetiformis, severe rash, Staphylococcus aureus infection, etc.
- •3. Patients with allergic contact dermatitis to medical adhesives
- •4. Patients with severe hypoglycemia events requiring emergency medical treatment within 6 months prior to screening
- •5. Patients with >1 episode of diabetic ketoacidosis within the past 6 months prior to screening
- •6. Patients with cerebrovascular diseases or cardiovascular diseases when instable (defined by event or increasing symptoms in the last 6 months) or with insufficient therapy, including, but not limited to:
- •Ischemic heart disease, peripheral vascular disease, cardiomyopathy, congenital heart disease, serious arrhythmia, etc.
- •7. Patients with epilepsy, syncope, or adrenal disorders within 6 months prior to screening
- •8. Patients with chronic infectious disease
- •9. Patients with anemia (hemoglobin below normal range)
- •10. Patients scheduled for unchangeable X-ray, MRI, or CT during the study
- •11. Pregnant or lactating women or those who plan to become pregnant or do not agree to use an adequate method of contraception during the study
- •12. Patients who are currently participating or participated within 2 weeks prior to screening in another study or plan to participate in another study that in the opinion of the investigator would affect the safety of the study subject or the study result
- •13. Patients unwilling to abstain from use of nutritional supplements containing xylose
- •14. Patients with cognitive impairment or who are not suitable for this study or may be at increased risk associated with study participation in the opinion of the investigator
- •15. Wearing of a pace maker or other comparable medical devices
- •16. Dependency from the sponsor or the clinical investigator
- •17. Hypoglycemia unawareness
- •18. History of frequent catheter abscesses associated with pump therapy
- •19. HbA1c >9.5%
- •20. Severe diabetes-relevant complications (i.e. severe macroangiopathy, severe microangiopathy, severe neuro-, retino- or nephropathy)
- •21. Unable to understand, read and write German
研究者
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