Evaluation of the EarEEG System for Detection of Hypoglycaemia-induced Changes in the EEG in Subjects With Type 1 Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes Research Center

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

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
Epilepsy
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
Pregnancy

Treatment and study plan

Ear-EEG system

Device

Measurement of the neural activity in the brain by use of the Ear-EEG device, which is a customized earplug containing 6 embedded dry electrodes placed inside the ear canal and in the concha of the ear.

Primary outcomes

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)

Time frame: Up to 8 hours

During insulin-induced hypoglycaemia

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

T&W Engineering A/S
UNEEG Medical A/S
University of Aarhus

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Jan 16, 2017
Registry last updated: Apr 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed