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

NCT ID: NCT03022058

Last Updated: 2018-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-22
• Study Completion Date: 2017-11-16

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with type 1 diabetes mellitus

Group Type: EXPERIMENTAL

Ear-EEG system

Intervention Type: 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.

Interventions

Ear-EEG system

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Informed consent obtained before any study related activities1

2. Age 18-70 years

3. Patients with type 1 diabetes (duration ≥ 5 years)

Exclusion Criteria

1. Severe cardiac disease

1. History of myocardial infarction

2. Cardiac arrhythmia

2. Previous stroke or cerebral haemorrhage and any other structural cerebral disease

3. Uraemia defined as s-creatinine ≥ 3 times upper reference value,

4. Liver disease defined as s-ALAT ≥ 3 times upper reference interval

5. Epilepsy

6. Use of antiepileptic drugs for any purposes

7. Use of the following drugs: Chemotherapeutic drugs of any kind, methotrexate, third generation antipsychotic drugs (aripiprazole, quetiapine, clozapine, ziprasidone, paliperidone, risperidone, sertindole, amisulpride, olanzapine)

8. Known or suspected abuse of alcohol defined as estimated consumption beyond that, which is recommended by the DHA1 or any other neuro-active substances

9. Use of hearing aid or cochlear implants2

10. Allergic contact dermatitis caused by metals or generally prone to skin irritation

11. Narrow or malformed ear canals

12. Patients that are judged incapable of understanding the patient information or who are not capable of carrying through the investigation

13. Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: collaborator

T&W Engineering A/S

INDUSTRY

Sponsor Role: collaborator

UNEEG Medical A/S

INDUSTRY

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Henning Beck-Nielsen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henning Beck-Nielsen, DMSc

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

Diabetes Research Center

Odense, , Denmark

Countries

Denmark

Other Identifiers

56205

Identifier Type: -

Identifier Source: org_study_id