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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03022058

Enrollment

Registered

2017-01-16

Start date

2017-06-22

Completion date

2017-11-16

Last updated

2018-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

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.

Interventions

DEVICEEar-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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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)	Up to 8 hours	During insulin-induced hypoglycaemia

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026