EEG-Changes During Insulininduced Hypoglycemia in Type 1 Diabetes
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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:
- Detection of hypoglycemia-induced EEG changes using subcutaneous electrodes
- 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 |
| 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 |
Twenty adult patients with type 1 diabetes will be participating in the study.
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 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 Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013