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

Not Applicable

Completed

Conditions: Healthy

Interventions: Device: Hyposafe device

Registration Number: NCT02402153

Lead Sponsor: UNEEG Medical A/S

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 18

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sydvestjysk Hospital	Hyposafe device	Investigation of EEG recording with the Hyposafe device

Primary Outcome Measures

Name	Time	Method
Performance: EEG Quality	1 month	The power spectrum densities from the two modalities were directly compared on an integer scale from -5 to 5, where "-5" signifies that the scalp EEG was of much higher quality than the subcutaneous. "0" means they were of equal quality and "5" means the subcutaneous signal was of much higher quality
Performance: EEG Recordings - Impedance	1 month	The EEG performance was measured as the mean impedance as a function of time. An impedance value below 5 kOhm is considered very good.
Performance: Continuous EEG	1 month	Average time of EEG recordings (hours/day)

Secondary Outcome Measures

Name	Time	Method
Usability: Reported Discomfort Related to the Implant in the Beginning of the Study	19±4 days after implantation	The discomfort was recorded by the study subjects 19±4 days after implantation. Reported discomfort was evaluated by the following question: "How much do you agree with the following statement: I have not experienced any implant discomfort the past two days?". The scale ranged from 1 to 5 (strongly agree = 5, agree = 4, neutral = 3, disagree = 2, strongly disagree=1).
Usability: Reported Discomfort During Day While Wearing the Device	1 month	The discomfort during the day was recorded by the study subject every day wearing the device. Reported discomfort was evaluated by the following question: "How much do you agree with the following statement: There has been no discomfort while wearing the HypoSafe device during day?". The scale ranged from 1 to 5 (strongly agree = 5, agree = 4, neutral = 3, disagree = 2, strongly disagree=1).
Usability: Reported Discomfort During Night While Wearing the Device	1 month	The discomfort during the night was recorded by the study subject every night wearing the device. Reported discomfort was evaluated by the following question: "How much do you agree with the following statement: There has been no discomfort while wearing the HypoSafe device during night?". The scale ranged from 1 to 5 (strongly agree = 5, agree = 4, neutral = 3, disagree = 2, strongly disagree=1).
Usability: Reported Discomfort Related to the Implant at the End of the Study	51±3 days after implantation	The discomfort was recorded by the study subjects 51±3 days after implantation. Reported discomfort was evaluated by the following question: "How much do you agree with the following statement: I have not experienced any implant discomfort the past two days?". The scale ranged from 1 to 5 (strongly agree = 5, agree = 4, neutral = 3, disagree = 2, strongly disagree=1).