NCT02402153已完成不适用
Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - the Pilot 2 Study - Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Performance: EEG Quality
研究概览
简要总结
The objective of this pilot trial is to demonstrate the safety and the performance of the Hyposafe hypoglycaemia alarm device before conducting clinical trials in type 1 diabetes patients.
详细描述
- Safety: To evaluate safety issues related to implantation and use of the Hyposafe hypoglycaemia alarm device.
- Performance: To evaluate the performance of the Hyposafe hypoglycaemia alarm device.
- Usability: To obtain information about the subjects use and acceptance of the Hyposafe 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
- Device Feasibility
- 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 subjects
- •Age 18-70 years
- •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
- •Uraemia defined as s-creatinine above 3 times upper reference value
- •Liver disease defined as s-alanine aminotransferase (s-ALAT) above 3 times upper reference interval
- •Use of antiepileptic drugs for any purposes
- •Clinical important hearing impairment
- •Use of active implantable medical device including
- •Pacemaker and Implantable Cardioverter Defibrillator (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 neuro-active substances
- •Infection at the site of device-implantation
- •Any haemorrhagic disease
- •Diving (snorkel diving allowed) or parachute jumping
- •Patients that are judged incapable to understand the patient information or who are unlikely to complete the investigation for any reason
- •Persons operating MRI scanners.
- •Persons operating handheld transceivers for communication (e.g. within the police, medical, fire, air traffic control, marine or military).
- •Persons working at broadcast stations for television or FM/DAB radio.
- •Persons performing extreme sport.
研究组 & 干预措施
Sydvestjysk Hospital
Other
Investigation of EEG recording with the Hyposafe device
干预措施: Hyposafe device (Device)
结局指标
主要结局
Performance: EEG Quality
时间窗: 1 month
The power spectrum densities from the two modalities were directly compared on an integer scale from -5 to 5, where "-5" signifies that the scalp EEG was of much higher quality than the subcutaneous. "0" means they were of equal quality and "5" means the subcutaneous signal was of much higher quality
Performance: EEG Recordings - Impedance
时间窗: 1 month
The EEG performance was measured as the mean impedance as a function of time. An impedance value below 5 kOhm is considered very good.
Performance: Continuous EEG
时间窗: 1 month
Average time of EEG recordings (hours/day)
次要结局
- Usability: Reported Discomfort Related to the Implant in the Beginning of the Study(19±4 days after implantation)
- Usability: Reported Discomfort During Day While Wearing the Device(1 month)
- Usability: Reported Discomfort During Night While Wearing the Device(1 month)
- Usability: Reported Discomfort Related to the Implant at the End of the Study(51±3 days after implantation)
研究者
研究点 (1)
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