Healthy
Conditions
Keywords
Evaluation of subcutaneous EEG recording
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.
Interventions
DEVICEHyposafe device
Subcutaneous EEG recorder for EEG measurements
Sponsors
UNEEG Medical A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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: 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: Continuous EEG | 1 month | Average time of EEG recordings (hours/day) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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). |
| 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 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). |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sydvestjysk Hospital Observational EEG recording with the Hyposafe device
Hyposafe device: Subcutaneous EEG recorder for EEG measurements | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Sydvestjysk Hospital |
|---|---|
| Age, Continuous | 37 years |
| Blood pressure (diastolic) | 79 mmHg |
| Blood pressure (systolic) | 123 mmHg |
| Height | 175.7 Centimeter |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment Denmark | 18 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 8 Participants |
| Weight | 87 Kg |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 15 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Performance: Continuous EEG
Average time of EEG recordings (hours/day)
Time frame: 1 month
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sydvestjysk Hospital | Performance: Continuous EEG | 20.3 hours/day | Standard Deviation 2.1 |
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
Time frame: 1 month
Population: Exclusion of data points (n=5) in the analysis: A software bug and usage error of the control setup.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sydvestjysk Hospital | Performance: EEG Quality | 0.4 Score | Standard Deviation 0.8 |
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.
Time frame: 1 month
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sydvestjysk Hospital | Performance: EEG Recordings - Impedance | 2.3 Impedance (kOhm) | Standard Deviation 0.13 |
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).
Time frame: 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sydvestjysk Hospital | Usability: Reported Discomfort During Day While Wearing the Device | 4.1 units on a scale |
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).
Time frame: 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sydvestjysk Hospital | Usability: Reported Discomfort During Night While Wearing the Device | 3.8 units on a scale |
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).
Time frame: 51±3 days after implantation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sydvestjysk Hospital | Usability: Reported Discomfort Related to the Implant at the End of the Study | 4.3 units on a scale | Standard Deviation 1.1 |
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).
Time frame: 19±4 days after implantation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sydvestjysk Hospital | Usability: Reported Discomfort Related to the Implant in the Beginning of the Study | 3.8 units on a scale | Standard Deviation 1.3 |