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EEG-Changes During Insulininduced Hypoglycemia in Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Hypo-Safe A/S
ClinicalTrials.gov Identifier:
NCT00810420
First received: December 17, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

The aim of this study is based on recent pilot studies carried out at Odense University Hospital showing that the acute changes in electroencephalographic (EEG) signals (i.e. electrical activity inthe brain) elicited by insulin-induced hypoglycemia in patients with type 1 diabetes can be reliable detected by real-time processing of these EEG signals using mathematical algorithms and state of the art noise and artifact reduction. These preliminary results also showed that the hypoglycemia-induced EEG changes are detectable 15-30 min before deterioration in cognitive function impedes an adequate response to warning. We hypothesize that these observations apply to the majority of patients with type 1 diabetes, and therefore, that it is possible to develop an automated device to detect hypoglycemic episodes by continuous real-time monitoring and processing of EEG signals. To test our hypothesis, the specific aims of the present proposal are:

  1. Detection of hypoglycemia-induced EEG changes using subcutaneous electrodes
  2. Ambulatory EEG monitoring using subcutaneous electrodes

Condition
Hypoglycemia
Type 1 Diabetes

Study Type: Observational
Official Title: EEG-Changes During Insulininduced Hypoglycemia in Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Hypo-Safe A/S:

Study Start Date: February 2007
Study Completion Date: April 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Study Population

Twenty adult patients with type 1 diabetes will be participating in the study.

Criteria

Inclusion Criteria

  • 18-60 year old subjects
  • Type 1 diabetics with complete or partial hypoglycemia unawareness.
  • Ability to comprehend and a willingness to sign an informed consent form

Exclusion Criteria:

  • Neurological or psychiatric disease.
  • Current use of neuroactive medication or recreational drugs.
  • Pregnancy.
  • Patients with known heart disease, former myocardial infarction or cardiac arrhythmia
  • Patients with known epilepsy or in treatment with anti-epileptic drugs for all purposes
  • Patients treated with drugs that are known to influence the EEG, including benzodiazepines and other anxiolytics, anti-depressants and beta-blocking agents
  • Patients that are judged incapable of understanding the patient information or who are not capable of carrying through the investigation
  • Cancer of any kind
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810420

Locations
Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Hypo-Safe A/S
Investigators
Principal Investigator: Claus B Juhl, Phd Hyposafe A/S
  More Information

No publications provided by Hypo-Safe A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rasmus Jensen, HypoSafe A/S
ClinicalTrials.gov Identifier: NCT00810420     History of Changes
Other Study ID Numbers: Hyposafe-hypo-01
Study First Received: December 17, 2008
Last Updated: December 17, 2008
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Keywords provided by Hypo-Safe A/S:
Hypoglycemia
EEG
type 1 diabetes
neuroglycopenia
Hypoglycemia is a potential dangerous condition
EEG is changed during hypoglycemia
A hypoglycemia alarm based on EEG-measures may prevent development of severe hypoglycemia

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

ClinicalTrials.gov processed this record on November 20, 2014