CTRI/2013/12/004204招募中不适用
A Feasibility Trial to Evaluate the Senseonics Continuous Glucose Monitoring System with Type - 2 Diabetes Patient.
Senseonics Inc1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年11月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To assess accuracy and longevity of the Senseonics CGM System modifications and to assess safety of the Senseonics CGM System during up to 84 days of Sensor use in the clinic and during home use
研究概览
简要总结
The purpose of this clinical trial is to evaluate the effectiveness of modified Sensor designs on the longevity (up to 90 days) of the Senseonics CGM System. The trial will also evaluate the safety of the Senseonics CGM System during clinical use as well as during home use with a blinded display.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age ≥ 18 to ≤ 65 years at screening
- •Clinically confirmed diagnosis of Type 1 diabetes mellitus (for at least I year of duration on multiple daily injections (>2 injections per day) or on insulin pump therapy.
- •Subject understands study procedures and risks, is willing to comply with protocol requirements, and has signed an informed consent document.
- •HbA1c ≤ 10%.
排除标准
- •History of severe hypoglycemia in the 6 months immediately prior to study start.
- •Severe diabetic Ketoacidosis in the past 6 months.
- •Females who are lactating, pregnant or intending to become pregnant during the course of the investigation.
- •Any condition preventing or complicating the placement, operation or removal of the Sensor.
- •Any medical condition or illness that in the judgment of the investigator might interfere with the procedures, results or compliance during the course of this investigation, or increase the risk of induced hypoglycemia or repeated blood testing.
- •Known microvascular (diabetic) complications (other than non-proliferative retinopathy), including active proliferative diabetic retinopathy or macular edema, non-proliferative retinopathy stage 3, diabetic nephropathy (other than microalbuminuria with normal creatinine), gastroparesis or neuropathy requiring treatment.
- •Currently receiving any of the following therapies, or likely to need such treatment during the follow-up period of this study: Immunosuppressant therapy Chemotherapy for any form of cancer Anti-coagulant therapy (e.g. Plavix, LMW heparin, coumadin)
- •Magnesium <1.6 mg/dL at screening.
- •Potassium <3.4 mmol/L at screening.
- •Hematocrit >50% or <30% at screening.
- •Topical or local anesthetic allergy.
- •Known current or recent alcohol or drug abuse by Subject history.
- •Participation in another clinical investigation within 30 days preceding screening, or intention to participate in any other clinical investigation during the period of this study.
- •The presence of any other active implanted device, whether turned on or off.
- •Passive implants are allowed.
- •A condition requiring or likely to require the use of magnetic resonance imaging (MRI).
- •Any condition that in the investigator’s opinion would make the Subject unable to complete the study.
- •Investigator will supply rationale.
结局指标
主要结局
To assess accuracy and longevity of the Senseonics CGM System modifications and to assess safety of the Senseonics CGM System during up to 84 days of Sensor use in the clinic and during home use
时间窗: Day 0, 14, 28, 42, 56, 70, 84 and 91
次要结局
- To determine other relevant Senseonics CGM System performance measures.(To evaluate the incidence of procedure and device-related adverse events in clinic and home use.)
研究者
研究点 (1)
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