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Trial record 11 of 873 for:    hypoglycemia | "Diabetes Mellitus, Insulin-Dependent"

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
Sponsor:
Collaborators:
University of Aarhus
T&W Engineering A/S
UNEEG Medical A/S
Information provided by (Responsible Party):
Henning Beck-Nielsen, Odense University Hospital

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: Ear-EEG system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Denmark
Diabetes Research Center
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
University of Aarhus
T&W Engineering A/S
UNEEG Medical A/S
Investigators
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Principal Investigator: Henning Beck-Nielsen, DMSc Odense University Hospital

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Responsible Party: Henning Beck-Nielsen, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03022058     History of Changes
Other Study ID Numbers: 56205
First Posted: January 16, 2017    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases