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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Ear-EEG system
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

  • Diabetes Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with type 1 diabetes mellitus

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 13, 2016
Last Updated
April 9, 2018
Sponsor
Odense University Hospital
Collaborators
University of Aarhus, T&W Engineering A/S, UNEEG Medical A/S
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1. Study Identification

Unique Protocol Identification Number
NCT03022058
Brief Title
Evaluation of the EarEEG System for Detection of Hypoglycaemia-induced Changes in the EEG in Subjects With Type 1 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 22, 2017 (Actual)
Primary Completion Date
November 16, 2017 (Actual)
Study Completion Date
November 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
University of Aarhus, T&W Engineering A/S, UNEEG Medical A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with type 1 diabetes mellitus
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Ear-EEG system
Intervention Description
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 Outcome Measure Information:
Title
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)
Description
During insulin-induced hypoglycaemia
Time Frame
Up to 8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henning Beck-Nielsen, DMSc
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetes Research Center
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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