HealthyNCT02402153

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

A study testing Hyposafe device in people with Healthy, run by UNEEG Medical A/S at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Hyposafe device
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteDenmark
Study dates: Nov 2014to Mar 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 26Show fewer

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 locations and contacts

1 site in 1 country.

Denmark1 site

Sydvestjysk Hospital
Esbjerg, 6800

Other trials in Denmark

About this study

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.

Read the detailed description

Safety: To evaluate safety issues related to implantation and use of the Hyposafe hypoglycaemia alarm device.
Performance: To evaluate the performance of the Hyposafe hypoglycaemia alarm device.
Usability: To obtain information about the subjects use and acceptance of the Hyposafe Hypoglycaemia alarm device.

Conditions: Healthy
Being tested: Hyposafe device
Keywords: Evaluation of subcutaneous EEG recording

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hyposafe deviceDevice
Subcutaneous EEG recorder for EEG measurements

Study groups in NCT02402153
Study group	Role	What they receive
Sydvestjysk Hospital	Other	Investigation of EEG recording with the Hyposafe device Receives: Device: Hyposafe device

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 month
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
Measured: 1 month
Performance: Continuous EEG
Average time of EEG recordings (hours/day)
Measured: 1 month

Secondary outcomes (4)

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).
Measured: 1 month
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).
Measured: 1 month
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).
Measured: 19±4 days after implantation
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).
Measured: 51±3 days after implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Mar 2017

First posted30 Mar 2015 (estimated)
Study startNov 2014
Primary completionJan 2017
Study completionMar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02402153
Sponsor's protocol ID: Pilot 2_health_v2_August 27th
Status last verified: Sep 2018
First submitted: 18 Mar 2015
Last updated: 26 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - the Pilot 2 Study - Healthy Subjects
ClinicalTrials.gov ID: NCT02402153
Acronym / sponsor ID: Pilot 2_health_v2_August 27th
Conditions: Healthy
Keywords: Evaluation of subcutaneous EEG recording
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: UNEEG Medical A/SIndustry (pharma, biotech, devices)
Study start: Nov 2014
Primary completion: Jan 2017 (actual)
Study completion: Mar 2017 (actual)
First posted: 30 Mar 2015 (estimated)
Results: Posted 26 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Safety: To evaluate safety issues related to implantation and use of the Hyposafe hypoglycaemia alarm device.
Performance: To evaluate the performance of the Hyposafe hypoglycaemia alarm device.
Usability: To obtain information about the subjects use and acceptance of the Hyposafe Hypoglycaemia alarm device.

Study design

Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Sydvestjysk Hospital	Other	Device: Hyposafe deviceInvestigation of EEG recording with the Hyposafe device

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (26 listed)

Severe cardiac disease
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hyposafe deviceSubcutaneous EEG recorder for EEG measurements	Device	Sydvestjysk Hospital

Primary outcome

Performance: EEG Recordings - Impedance
Time frame: 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: EEG Quality
Time frame: 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: Continuous EEG
Time frame: 1 month
Average time of EEG recordings (hours/day)

4 secondary outcomes

Usability: Reported Discomfort During Day While Wearing the Device
Time frame: 1 month
Usability: Reported Discomfort During Night While Wearing the Device
Time frame: 1 month
Usability: Reported Discomfort Related to the Implant in the Beginning of the Study
Time frame: 19±4 days after implantation
Usability: Reported Discomfort Related to the Implant at the End of the Study
Time frame: 51±3 days after implantation

Results and safety

Results posted to the registry on 26 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sydvestjysk Hospital	18	18

Primary outcome: Performance: EEG Recordings - Impedance

Time frame: 1 month. Mean (Standard Deviation). Unit: Impedance (kOhm)

Measure	Sydvestjysk Hospital n = 12
Value	2.3 (0.13)

Population analysed: Exclusion of data points (n=6) in the analysis: A software bug resulted in no data storage (n=2). After a protocol amendment, EEG data was collected for the first 3 weeks only. The subsequent 2 weeks subjects were monitored, but EEG data not collected (n=4).

Primary outcome: Performance: EEG Quality

Time frame: 1 month. Mean (Standard Deviation). Unit: Score

Measure	Sydvestjysk Hospital n = 13
Value	0.4 (0.8)

Population analysed: Exclusion of data points (n=5) in the analysis: A software bug and usage error of the control setup.

Primary outcome: Performance: Continuous EEG

Time frame: 1 month. Mean (Standard Deviation). Unit: hours/day

Measure	Sydvestjysk Hospital n = 10
Value	20.3 (2.1)

Population analysed: Exclusion of data points (n=8) in the analysis: A software bug resulted in reduced data storage (n=4). After an amendment to the study protocol, EEG data was collected for the first 3 weeks. The subsequent 2 weeks subjects were monitored, but EEG data not collected (n=4).

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events (AEs) were collected from first subject first visit to last subject last follow-up. Total period for AE collection was 2 years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sydvestjysk Hospital	0 of 18 (0%)	15 of 18 (83.3%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Birger Thorsteinsson, MD, DMSc principal investigator

Nordsjaellands Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Hyposafe device in people with Healthy, run by UNEEG Medical A/S at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance: EEG Recordings - Impedance (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02402153.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.