EEG-Changes During Insulininduced Hypoglycemia in Type 1 Diabetes

NCT00810420 | Completed

• 1 other identifier: Hyposafe-hypo-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypoglycemia; Type 1 Diabetes

Keywords

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNEEG Medical A/S: lead

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

• Juhl CB, Hojlund K, Elsborg R, Poulsen MK, Selmar PE, Holst JJ, Christiansen C, Beck-Nielsen H. Automated detection of hypoglycemia-induced EEG changes recorded by subcutaneous electrodes in subjects with type 1 diabetes--the brain as a biosensor. Diabetes Res Clin Pract. 2010 Apr;88(1):22-8. doi: 10.1016/j.diabres.2010.01.007. Epub 2010 Jan 15.

  PMID: 20074827 DERIVED

MeSH Terms

Conditions

Hypoglycemia; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Claus B Juhl, Phd

  HypoSafe A/S

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 18, 2008
• Study Start: February 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: April 1, 2008
• Last Updated: December 18, 2008

Record last verified: 2008-12

Locations

DK (1)