ACTRN12622000290796已完成未知
A prospective, single arm, open-label, interventional, pivotal study to evaluate the efficacy and safety of a novel Continuous Glucose Monitoring System in adult patients with type 1 and type 2 diabetes
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
- 69
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Adults who are 18 years of age or above
- •2.Patients with type 1 and type 2 diabetes who use intensive insulin therapy with known dosing parameters and at least one of the following two options of insulin requirements:
- •-at least 2 injections daily, or
- •-at least 0.2 units of insulin/kg/day
- •3.Patients who voluntarily decide 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 (greater than 150 / 80 mmHg)
- •c.)HbA1c greater than 9.0 %
- •2.Patients with the following uncontrolled abnormal skin/skin diseases at the CGM sensor attachment 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 moderate/severe allergic contact dermatitis to medical adhesives
- •4.Patients with severe hypoglycemia events within 6 months prior to screening
- •Severe hypoglycemia: Loss of consciousness or seizure requiring emergency medical treatment due to hypoglycemia
- •5.Patients with more than 1 episode of diabetic ketoacidosis within the past 6 months prior to screening
- •6.Patients with cerebrovascular diseases or the following cardiovascular diseases (but not limited to) when instable (defined by event or increasing symptoms in the last 6 months) or with insufficient therapy:
- •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 laboratory determinded normal range for age and sex).
- •10.Patients scheduled for unchangeable X-ray, MRI, or CT during the study
- •11.Pregnant, 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
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