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

NCT02402153 | Completed Results DMC

• 1 other identifier: Pilot 2_health_v2_August 27th
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Evaluation of subcutaneous EEG recording

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• Usability: Reported Discomfort During Day While Wearing the Device

  1 month

• Usability: Reported Discomfort During Night While Wearing the Device

  1 month

• Usability: Reported Discomfort Related to the Implant in the Beginning of the Study

  19±4 days after implantation

• Usability: Reported Discomfort Related to the Implant at the End of the Study

  51±3 days after implantation

Study Arms (1)

Sydvestjysk Hospital

OTHER

Investigation of EEG recording with the Hyposafe device

Device: Hyposafe device

Interventions

Hyposafe device DEVICE

Subcutaneous EEG recorder for EEG measurements

Sydvestjysk Hospital

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNEEG Medical A/S: lead

Study Sites (1)

Sydvestjysk Hospital

Esbjerg, 6800, Denmark

Location

Results Point of Contact

• Title: Clinical Manager
• Organization: UNEEG medical A/S

lybl@UNEEG.com

+45 41414244

Study Officials

• Birger Thorsteinsson, MD, DMSc

  Nordsjaellands Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: March 30, 2015
• Study Start: November 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: March 1, 2017
• Last Updated: September 26, 2018
• Results First Posted: September 26, 2018

Record last verified: 2018-09

Locations

DK (1)