NCT01238016终止不适用
Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - a Pilot Study - A One Month Non-controlled Observational Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Device performance
研究概览
简要总结
The trial aims at measuring the safety and performance of the Hyposafe device.
详细描述
Safety: To evaluate safety issues related to implantation and use of the Hyposafe hypoglycaemia alarm device Performance: To evaluate the stability of the hypoglycaemia alarm device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy control subjects or and
- •Male and female patient with type 1 diabetes for at least one year
- •Age 18-70 years
- •Impaired awareness of hypoglycaemia as defined by
- •A score of ≥4 on the Gold-scale or
- •Two or more occasions of severe hypoglycaemia (need of help from third person) within the past 12 month
- •Multiple injection insulin therapy or continuous insulin injection therapy
- •For female participants: Not pregnant and, if child bearing potential, usage of reliable anti-contraceptive method during the study period
排除标准
- •Severe cardiac disease
- •History of myocardial infarction
- •Cardiac arrhythmia
- •Previous stroke or cerebral haemorrhage and any other structural cerebral disease
- •Active cancer or cancer diagnosis within the past five years
- •Uremia defined as s-creatinine above 3 times upper reference value
- •Liver disease defined as s-ALAT above 3 times upper reference interval
- •Inability to understand the informed consent
- •Use of antiepileptic drugs for any purposes
- •Clinical important hearing impairment
- •Use of active implantable medical device including
- •Pacemaker and ICD-unit
- •Cochlear implant
- •Use of following drugs
- •Chemotherapeutic drugs of any kind
- •Methotrexate
- •Third generation antipsychotic drugs (aripiprazole, quetiapine, clozapine, ziprasidone, paliperidone, risperidone, sertindole, amisulpride, olanzapine)
- •Abuse of alcohol (defined as consumption of > 250g alcohol (in Danish: 21 "genstande") per week or abuse of any other neuroactive substances
- •Infection at the site of device-implantation
- •Any hemorrhagic disease
- •Diving (snorkel diving allowed) or parachute jumping
- •Patients that are judged incapable of understanding the patient information or who are not capable of carrying through the investigation
研究组 & 干预措施
device
Other
Device implant and EEG recording
干预措施: experimental (Device)
结局指标
主要结局
Device performance
时间窗: End of observation
次要结局
未报告次要终点
研究者
研究点 (1)
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