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

UNEEG medical

Status: Completed

Conditions: Healthy

Treatments: Device: Hyposafe device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02402153

Pilot 2_health_v2_August 27th

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Sydvestjysk Hospital

Other group

Description:

Investigation of EEG recording with the Hyposafe device

Treatment:

Device: Hyposafe device