Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - the Pilot 2 Study - Healthy Subjects

Study Overview
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Brief Summary
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The objective of this pilot trial is to demonstrate the safety and the performance of the Hyposafe hypoglycaemia alarm device before conducting clinical trials in type 1 diabetes patients.

Detailed Description
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Safety: To evaluate safety issues related to implantation and use of the Hyposafe hypoglycaemia alarm device. Performance: To evaluate the performance of the Hyposafe hypoglycaemia alarm device. Usability: To obtain information about the subjects use and acceptance of the Hyposafe Hypoglycaemia alarm device.

Official Title
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Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - the Pilot 2 Study - Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Device: Hyposafe device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects Age 18-70 years For female participants: Not pregnant and, if child bearing potential, usage of reliable anti-contraceptive method during the study period 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 Uraemia defined as s-creatinine above 3 times upper reference value Liver disease defined as s-alanine aminotransferase (s-ALAT) above 3 times upper reference interval Epilepsy Use of antiepileptic drugs for any purposes Clinical important hearing impairment Use of active implantable medical device including Pacemaker and Implantable Cardioverter Defibrillator (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 neuro-active substances Infection at the site of device-implantation Any haemorrhagic disease Diving (snorkel diving allowed) or parachute jumping Patients that are judged incapable to understand the patient information or who are unlikely to complete the investigation for any reason Persons operating MRI scanners. Persons operating handheld transceivers for communication (e.g. within the police, medical, fire, air traffic control, marine or military). Persons working at broadcast stations for television or FM/DAB radio. Persons performing extreme sport.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sydvestjysk Hospital<br>Investigation of EEG recording with the Hyposafe device | Device: Hyposafe device<br>* Subcutaneous EEG recorder for EEG measurements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance: EEG Recordings - Impedance | The EEG performance was measured as the mean impedance as a function of time. An impedance value below 5 kOhm is considered very good. | 1 month | 
| Performance: EEG Quality | The power spectrum densities from the two modalities were directly compared on an integer scale from -5 to 5, where -5 signifies that the scalp EEG was of much higher quality than the subcutaneous. 0 means they were of equal quality and 5 means the subcutaneous signal was of much higher quality | 1 month | 
| Performance: Continuous EEG | Average time of EEG recordings (hours/day) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability: Reported Discomfort During Day While Wearing the Device | The discomfort during the day was recorded by the study subject every day wearing the device. Reported discomfort was evaluated by the following question: How much do you agree with the following statement: There has been no discomfort while wearing the HypoSafe device during day?. The scale ranged from 1 to 5 (strongly agree = 5, agree = 4, neutral = 3, disagree = 2, strongly disagree=1). | 1 month | 
| Usability: Reported Discomfort During Night While Wearing the Device | The discomfort during the night was recorded by the study subject every night wearing the device. Reported discomfort was evaluated by the following question: How much do you agree with the following statement: There has been no discomfort while wearing the HypoSafe device during night?. The scale ranged from 1 to 5 (strongly agree = 5, agree = 4, neutral = 3, disagree = 2, strongly disagree=1). | 1 month | 
| Usability: Reported Discomfort Related to the Implant in the Beginning of the Study | The discomfort was recorded by the study subjects 19±4 days after implantation. Reported discomfort was evaluated by the following question: How much do you agree with the following statement: I have not experienced any implant discomfort the past two days?. The scale ranged from 1 to 5 (strongly agree = 5, agree = 4, neutral = 3, disagree = 2, strongly disagree=1). | 19±4 days after implantation | 
| Usability: Reported Discomfort Related to the Implant at the End of the Study | The discomfort was recorded by the study subjects 51±3 days after implantation. Reported discomfort was evaluated by the following question: How much do you agree with the following statement: I have not experienced any implant discomfort the past two days?. The scale ranged from 1 to 5 (strongly agree = 5, agree = 4, neutral = 3, disagree = 2, strongly disagree=1). | 51±3 days after implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Evaluation of subcutaneous EEG recording