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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sydvestjysk Hospital | Other | Investigation of EEG recording with the Hyposafe device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyposafe device | Device | Subcutaneous EEG recorder for EEG measurements |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Performance: Continuous EEG | Average time of EEG recordings (hours/day) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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
Epilepsy
Use of antiepileptic drugs for any purposes
Clinical important hearing impairment
Use of active implantable medical device including
Use of following drugs
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.
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| Name | Affiliation | Role |
|---|---|---|
| Birger Thorsteinsson, MD, DMSc | Nordsjaellands Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydvestjysk Hospital | Esbjerg | 6800 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sydvestjysk Hospital | Observational EEG recording with the Hyposafe device Hyposafe device: Subcutaneous EEG recorder for EEG measurements |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sydvestjysk Hospital | Observational EEG recording with the Hyposafe device Hyposafe device: Subcutaneous EEG recorder for EEG measurements |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Mean | Standard Deviation | Impedance (kOhm) | 1 month |
|
Adverse Events (AEs) were collected from first subject first visit to last subject last follow-up. Total period for AE collection was 2 years.
Adverse Events (AEs) were collected as defined in the International Standards Organizations (ISO): ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice. All AEs were reported regardless of being related or unrelated to the device
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sydvestjysk Hospital | Observational EEG recording with the Hyposafe device Hyposafe device: Subcutaneous EEG recorder for EEG measurements |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular extrasystoles | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | Not device related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Manager | UNEEG medical A/S | +45 41414244 | lybl@UNEEG.com |
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| 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). | 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). | 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). | 51±3 days after implantation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Full Range | Kg |
|
| Height | Mean | Full Range | Centimeter |
|
| Blood pressure (systolic) | Mean | Full Range | mmHg |
|
| Blood pressure (diastolic) | Mean | Full Range | mmHg |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 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 | Exclusion of data points (n=5) in the analysis: A software bug and usage error of the control setup. | Posted | Mean | Standard Deviation | Score | 1 month |
|
|
|
| Primary | Performance: Continuous EEG | Average time of EEG recordings (hours/day) | 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). | Posted | Mean | Standard Deviation | 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). | Posted | Mean | Full Range | units on a scale | 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). | Posted | Mean | Full Range | units on a scale | 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). | Posted | Mean | Standard Deviation | units on a scale | 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). | Posted | Mean | Standard Deviation | units on a scale | 51±3 days after implantation |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 15 |
| 18 |
|
| Includes either ear swelling, ear discomfort, ear pain, or ear deformity acquired | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment | Device related |
|
| Vomiting and diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Not device related |
|
| Includes either implant site haematoma, discomfort or implant site pain | General disorders | MedDRA (Unspecified) | Systematic Assessment | Device related |
|
| Includes either nasopharyngitis, ear infection or food poisoning | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | Not device related |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment | Not device related |
|
| Includes either headache, post procedural headache or migrane | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Device related |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Systematic Assessment | Not device related |
|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment | Not device related |
|
Data is the property of UNEEG medical A/S. The PI is offered co-authorship for publications related to the investigation. If the PI does not agree on the interpretation of the results, then the PI have the right to publish and present the results.