- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01237509
EEG Changes of type1 Diabetes During Sleep -Insulin Induced Hypoglycemia (sleep)
Registration of EEG Changes During Sleep Associated With Insulin Induced Hypoglycemia in Type 1 Diabetic
Study Overview
Detailed Description
The different sleep stages are associated with specific EEG-changes of high complexity with the occurrence of slow frequency waves during stages of deep sleep.
The aim of this study is to assess EEG changes during insulin-induced hypoglycaemia in type 1 diabetes patients in the different stages of sleep. The core questions will be:
(i) Will the pathological hypoglycaemia-related EEG-changes dominate over the physiological sleep-related changes when hypoglycaemia occurs during sleep? (ii) Is it possible to refine the mathematical algorithm to an extend, where EEG-changes during hypoglycaemia can be distinguished from sleep-related EEG-changes in all sleep stages.
(iii) If so, at what blood-glucose level will hypoglycaemia associated EEG-changes be detectable and (iv) Will patients be able to react adequately by ingestion of carbohydrates if an alarm can is given at the time of hypoglycaemia associates EEG-changes.
Twelve patients with type 1 diabetes will be studied. EEG will be recorded during graded hypoglycaemia achieved by insulin infusion and frequent glucose measurements. EEG will be analysed by the automated algorithm and by visual analysis to address the questions (i), (ii) and (iii). To address question (iv) real-time EEG-analysis with a predefined threshold defining hypoglycaemia will be performed and an alarm will aim to warn the patients of impeding hypoglycaemia. Patients will be asked to consume carbohydrates at alarm.
During the experiments the patients will be under continuous observation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Esbjerg, Denmark, 6700
- Esbjerg Sygehus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Type 1 diabetes patients
- Hypoglycemia unawareness
- aged 18-70
Exclusion Criteria:
Severe cardiac disease
- History of myocardial infarction
- Cardiac arrhythmia
- Previous stroke or cerebral haemorrhage and any other structural cerebral disease
- Active cancer or cancer diagnosis within the past five years
- Uremia defined as s-creatinine above 3 times upper reference value
- Liver disease defined as s-ALAT above 3 times upper reference interval
- Inability to understand the informed consent
- Epilepsy
- Use of antiepileptic drugs for any purposes
- Clinical important hearing impairment
Use of active implantable medical device including
- Pacemaker and ICD-unit
- Cochlear implant
Use of following drugs
- Chemotherapeutic drugs of any kind
- Methotrexate
- Third generation antipsychotic drugs (aripiprazole, quetiapine, clozapine, ziprasidone, paliperidone, risperidone, sertindole, amisulpride, olanzapine)
- Abuse of alcohol (defined as consumption of > 250g alcohol (in Danish: 21 "genstande") per week or abuse of any other neuroactive substances
- Infection at the site of device-implantation
- Any hemorrhagic disease
- Diving (snorkel diving allowed) or parachute jumping
- Patients that are judged incapable of understanding the patient information or who are not capable of carrying through the investigation
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
group1
Patients with T1D
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hypoglycaemia associated EEG changes during sleep
Time Frame: 24 hours
|
24 hours
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soevn01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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