Status:
COMPLETED
EEG-Changes During Insulininduced Hypoglycemia in Type 1 Diabetes
Lead Sponsor:
UNEEG Medical A/S
Conditions:
Hypoglycemia
Type 1 Diabetes
Eligibility:
All Genders
18-60 years
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...
Detailed Description
The near-normalization of glycemic control has become an established treatment goal in diabetes in order to reduce late complications such as nephropathy, neuropathy, retinopathy and cardiovascular di...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
OBSERVATIONAL
End Date :
April 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00810420
Start Date
February 1 2007
End Date
April 1 2008
Last Update
December 18 2008
Active Locations (1)
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1
Odense University Hospital
Odense, Denmark, 5000