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

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: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Hyposafe device

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: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Esbjerg, Denmark, 6800
    • Sydvestjysk Hospital

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	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

Collaborators and Investigators

• Sponsor: UNEEG Medical A/S
• Investigators: Principal Investigator: Birger Thorsteinsson, MD, DMSc, Nordsjællands Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: March 18, 2015
• First Submitted That Met QC Criteria: March 27, 2015
• First Posted (Estimate): March 30, 2015

Study Record Updates

• Last Update Posted (Actual): September 26, 2018
• Last Update Submitted That Met QC Criteria: September 25, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Evaluation of subcutaneous EEG recording
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia
• Other Study ID Numbers: Pilot 2_health_v2_August 27th