Evaluation of the EarEEG System for Detection of Hypoglycaemia-induced Changes in the EEG in Subjects With Type 1 Diabetes: A Non-controlled, Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Presence of significant qEEG hypoglycaemia indicators when comparing normo- and hypoglycaemic EEG as measured by the EarEEG systems for subjects where hypoglycaemia-induced changes have been observed in the scalp EEG (visit 4)
研究概览
简要总结
The EarEEG system is a novel non-invasive, unobstructed and discrete method for recording EEG in which the signal is recorded using dry-contact electrodes embedded on a customised ear piece. One intended medical indication of the EarEEG system is the detection of hypoglycaemia-induced changes in the EEG in patients with type 1 diabetes. Currently, no studies exist investigating the detection of hypoglycaemic episodes by use of ear electrodes. While a finger prick test accurately measures the blood glucose level, it does not provide continuous measurements, and hence it is unreliable as a hypoglycaemia alarm. Recent studies have indicated that the use of continuous glucose monitoring (CGM) reduces the risk of severe hypoglycaemia. However, some find these devices troublesome to use and utilisation of CGM has remained limited to date. Observational data show that only a small percentage of patients with type 1 diabetes are using CGM on an ongoing basis. Thus, there is a medical need for a reliable hypoglycaemia detection device which is easy and convenient to use.
This clinical study aims at investigating the feasibility of measuring hypoglycaemia induced changes in the EEG by use of the EarEEG system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •For a subject to be eligible, all inclusion criteria must be answered "yes":
- •Informed consent obtained before any study related activities1
- •Age 18-70 years
- •Patients with type 1 diabetes (duration ≥ 5 years)
排除标准
- •For a subject to be eligible, all exclusion criteria must be answered "no":
- •Severe cardiac disease
- •History of myocardial infarction
- •Cardiac arrhythmia
- •Previous stroke or cerebral haemorrhage and any other structural cerebral disease
- •Uraemia defined as s-creatinine ≥ 3 times upper reference value,
- •Liver disease defined as s-ALAT ≥ 3 times upper reference interval
- •Use of antiepileptic drugs for any purposes
- •Use of the following drugs: Chemotherapeutic drugs of any kind, methotrexate, third generation antipsychotic drugs (aripiprazole, quetiapine, clozapine, ziprasidone, paliperidone, risperidone, sertindole, amisulpride, olanzapine)
- •Known or suspected abuse of alcohol defined as estimated consumption beyond that, which is recommended by the DHA1 or any other neuro-active substances
- •Use of hearing aid or cochlear implants2
- •Allergic contact dermatitis caused by metals or generally prone to skin irritation
- •Narrow or malformed ear canals
- •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
Patients with type 1 diabetes mellitus
干预措施: Ear-EEG system (Device)
结局指标
主要结局
Presence of significant qEEG hypoglycaemia indicators when comparing normo- and hypoglycaemic EEG as measured by the EarEEG systems for subjects where hypoglycaemia-induced changes have been observed in the scalp EEG (visit 4)
时间窗: Up to 8 hours
During insulin-induced hypoglycaemia
次要结局
未报告次要终点
研究者
Henning Beck-Nielsen
Professor
Odense University Hospital