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

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

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.

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.

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.