Evaluation of the EarEEG System for Detection of Hypoglycaemia-induced Changes in the EEG in Subjects With Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT03022058|
Recruitment Status : Completed
First Posted : January 16, 2017
Last Update Posted : April 11, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Device: Ear-EEG system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 22, 2017|
|Actual Primary Completion Date :||November 16, 2017|
|Actual Study Completion Date :||November 16, 2017|
|Experimental: Patients with type 1 diabetes mellitus||
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022058
|Diabetes Research Center|
|Odense, Denmark, 5000|
|Principal Investigator:||Henning Beck-Nielsen, DMSc||Odense University Hospital|