Trial Outcomes & Findings for Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - the Pilot 2 Study - Healthy Subjects (NCT NCT02402153)

Last Updated: 2018-09-26

Results Overview

The EEG performance was measured as the mean impedance as a function of time. An impedance value below 5 kOhm is considered very good.

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

1 month

Results posted on

2018-09-26

Participant Flow

Participant milestones

Participant milestones
Measure	Sydvestjysk Hospital Observational EEG recording with the Hyposafe device Hyposafe device: Subcutaneous EEG recorder for EEG measurements
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sydvestjysk Hospital n=18 Participants Observational EEG recording with the Hyposafe device Hyposafe device: Subcutaneous EEG recorder for EEG measurements
Age, Continuous	37 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Denmark	18 participants n=5 Participants
Weight	87 Kg n=5 Participants
Height	175.7 Centimeter n=5 Participants
Blood pressure (systolic)	123 mmHg n=5 Participants
Blood pressure (diastolic)	79 mmHg n=5 Participants

PRIMARY outcome

Timeframe: 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).

The EEG performance was measured as the mean impedance as a function of time. An impedance value below 5 kOhm is considered very good.

Outcome measures

Outcome measures
Measure	Sydvestjysk Hospital n=12 Participants Observational EEG recording with the Hyposafe device Hyposafe device: Subcutaneous EEG recorder for EEG measurements
Performance: EEG Recordings - Impedance	2.3 Impedance (kOhm) Standard Deviation 0.13

PRIMARY outcome

Timeframe: 1 month

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

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

Outcome measures

Outcome measures
Measure	Sydvestjysk Hospital n=13 Participants Observational EEG recording with the Hyposafe device Hyposafe device: Subcutaneous EEG recorder for EEG measurements
Performance: EEG Quality	0.4 Score Standard Deviation 0.8

PRIMARY outcome

Timeframe: 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).

Average time of EEG recordings (hours/day)

Outcome measures

Outcome measures
Measure	Sydvestjysk Hospital n=10 Participants Observational EEG recording with the Hyposafe device Hyposafe device: Subcutaneous EEG recorder for EEG measurements
Performance: Continuous EEG	20.3 hours/day Standard Deviation 2.1

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Sydvestjysk Hospital n=18 Participants Observational EEG recording with the Hyposafe device Hyposafe device: Subcutaneous EEG recorder for EEG measurements
Usability: Reported Discomfort During Day While Wearing the Device	4.1 units on a scale Interval 2.5 to 5.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Sydvestjysk Hospital n=18 Participants Observational EEG recording with the Hyposafe device Hyposafe device: Subcutaneous EEG recorder for EEG measurements
Usability: Reported Discomfort During Night While Wearing the Device	3.8 units on a scale Interval 1.75 to 5.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Sydvestjysk Hospital n=18 Participants Observational EEG recording with the Hyposafe device Hyposafe device: Subcutaneous EEG recorder for EEG measurements
Usability: Reported Discomfort Related to the Implant in the Beginning of the Study	3.8 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Sydvestjysk Hospital n=18 Participants Observational EEG recording with the Hyposafe device Hyposafe device: Subcutaneous EEG recorder for EEG measurements
Usability: Reported Discomfort Related to the Implant at the End of the Study	4.3 units on a scale Standard Deviation 1.1

Adverse Events

Sydvestjysk Hospital

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sydvestjysk Hospital n=18 participants at risk Observational EEG recording with the Hyposafe device Hyposafe device: Subcutaneous EEG recorder for EEG measurements
Cardiac disorders Ventricular extrasystoles	5.6% 1/18 • 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
Ear and labyrinth disorders Includes either ear swelling, ear discomfort, ear pain, or ear deformity acquired	38.9% 7/18 • 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
Gastrointestinal disorders Vomiting and diarrhoea	5.6% 1/18 • 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
General disorders Includes either implant site haematoma, discomfort or implant site pain	16.7% 3/18 • 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
Infections and infestations Includes either nasopharyngitis, ear infection or food poisoning	33.3% 6/18 • 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
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	5.6% 1/18 • 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
Nervous system disorders Includes either headache, post procedural headache or migrane	22.2% 4/18 • 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
Pregnancy, puerperium and perinatal conditions Pregnancy	5.6% 1/18 • 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
Vascular disorders Hypertension	5.6% 1/18 • 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

Additional Information

Clinical Manager

UNEEG medical A/S

Phone: +45 41414244

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER