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

September 25, 2018 updated by: UNEEG Medical A/S
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Esbjerg, Denmark, 6800
        • Sydvestjysk Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Sydvestjysk Hospital
Investigation of EEG recording with the Hyposafe device
Device: Hyposafe device
Subcutaneous EEG recorder for EEG measurements

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 month
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
1 month
Performance: Continuous EEG
Time Frame: 1 month
Average time of EEG recordings (hours/day)
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Usability: Reported Discomfort During Day While Wearing the Device
Time Frame: 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).
1 month
Usability: Reported Discomfort During Night While Wearing the Device
Time Frame: 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).
1 month
Usability: Reported Discomfort Related to the Implant in the Beginning of the Study
Time Frame: 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).
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UNEEG Medical A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Birger Thorsteinsson, MD, DMSc, Nordsjællands Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pilot 2_health_v2_August 27th

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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