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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02402153
• Other study ID #: Pilot 2_health_v2_August 27th
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: March 2017

Study information

• Verified date: September 2018
• Source: UNEEG Medical A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Hypoglycemia

Intervention

Device:
• Hyposafe device
Subcutaneous EEG recorder for EEG measurements

Locations

Country	Name	City	State
Denmark	Sydvestjysk Hospital	Esbjerg

Sponsors (1)

Lead Sponsor	Collaborator
UNEEG Medical A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance: EEG Recordings - Impedance	The EEG performance was measured as the mean impedance as a function of time. An impedance value below 5 kOhm is considered very good.	1 month
Primary	Performance: EEG Quality	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	1 month
Primary	Performance: Continuous EEG	Average time of EEG recordings (hours/day)	1 month
Secondary	Usability: Reported Discomfort During Day While Wearing the Device	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).	1 month
Secondary	Usability: Reported Discomfort During Night While Wearing the Device	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).	1 month
Secondary	Usability: Reported Discomfort Related to the Implant in the Beginning of the Study	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).	19±4 days after implantation
Secondary	Usability: Reported Discomfort Related to the Implant at the End of the Study	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).	51±3 days after implantation