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

Diabetes Mellitus, Type 1 Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03022058
• Other study ID #: 56205
• Status: Completed
• Phase: N/A
• First received: December 13, 2016
• Last updated: April 9, 2018
• Start date: June 22, 2017
• Est. completion date: November 16, 2017

Study information

• Verified date: April 2018
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 16, 2017
• Est. primary completion date: November 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

For a subject to be eligible, all inclusion criteria must be answered "yes":

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:

For a subject to be eligible, all exclusion criteria must be answered "no":

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Denmark	Diabetes Research Center	Odense

Sponsors (4)

Lead Sponsor	Collaborator
Odense University Hospital	T&W Engineering A/S, UNEEG Medical A/S, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	During insulin-induced hypoglycaemia	Up to 8 hours