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

• 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.

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.