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EEG-Changes During Insulininduced Hypoglycemia in Type 1 Diabetes

NCT00810420 · Status: COMPLETED · Type: OBSERVATIONAL

Last updated 2008-12-18

No results posted yet for this study

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

Conditions

Sponsors & Collaborators

  • UNEEG Medical A/S

    lead INDUSTRY

Principal Investigators

  • Claus B Juhl, Phd · HypoSafe A/S

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2007-10-31
Completion
2008-04-30

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00810420 on ClinicalTrials.gov