Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - a Pilot Study

Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - a Pilot Study - A One Month Non-controlled Observational Study

The trial aims at measuring the safety and performance of the Hyposafe device.

Safety: To evaluate safety issues related to implantation and use of the Hyposafe hypoglycaemia alarm device Performance: To evaluate the stability of the hypoglycaemia alarm device.

Inclusion Criteria:

Healthy control subjects or and

• Male and female patient with type 1 diabetes for at least one year

• Age 18-70 years

• Impaired awareness of hypoglycaemia as defined by

  • A score of ≥4 on the Gold-scale or
  • Two or more occasions of severe hypoglycaemia (need of help from third person) within the past 12 month

• Multiple injection insulin therapy or continuous insulin injection therapy

• 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

• 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