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

NCT ID: NCT02402153

Last Updated: 2018-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-03-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Sydvestjysk Hospital

Investigation of EEG recording with the Hyposafe device

Group Type: OTHER

Hyposafe device

Intervention Type: DEVICE

Subcutaneous EEG recorder for EEG measurements

Interventions

Hyposafe device

Subcutaneous EEG recorder for EEG measurements

Intervention Type: 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UNEEG Medical A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Birger Thorsteinsson, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Nordsjaellands Hospital

Locations

Sydvestjysk Hospital

Esbjerg, , Denmark

Countries

Denmark

Other Identifiers

Pilot 2_health_v2_August 27th

Identifier Type: -

Identifier Source: org_study_id