Clinical trial NCT02402153: Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - the Pilot 2 Study - Healthy Subjects
Official title: Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - the Pilot 2 Study - Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Evaluation of subcutaneous EEG recording
Lead sponsor: UNEEG Medical A/S
Sponsor class: INDUSTRY
First posted: 2015-03-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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: 1. Safety: To evaluate safety issues related to implantation and use of the Hyposafe hypoglycaemia alarm device.
2. Performance: To evaluate the performance of the Hyposafe hypoglycaemia alarm device.
3. Usability: To obtain information about the subjects use and acceptance of the Hyposafe Hypoglycaemia alarm device.

Eligibility criteria: 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.

Primary outcomes:
measure: Performance: EEG Recordings - Impedance
timeFrame: 1 month
measure: Performance: EEG Quality
timeFrame: 1 month
measure: Performance: Continuous EEG
timeFrame: 1 month
Secondary outcomes:
measure: Usability: Reported Discomfort During Day While Wearing the Device
timeFrame: 1 month
measure: Usability: Reported Discomfort During Night While Wearing the Device
timeFrame: 1 month
measure: Usability: Reported Discomfort Related to the Implant in the Beginning of the Study
timeFrame: 19±4 days after implantation
measure: Usability: Reported Discomfort Related to the Implant at the End of the Study
timeFrame: 51±3 days after implantation
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Sydvestjysk Hospital
Study officials:
affiliation: Nordsjællands Hospital
name: Birger Thorsteinsson, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References: