Evaluation of Hypo-Safe Hypoglycaemia Alarm Device - the Pilot 2 Study - Healthy Subjects
25. september 2018 opdateret af: UNEEG Medical A/S
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.
Studieoversigt
Detaljeret beskrivelse
- Safety: To evaluate safety issues related to implantation and use of the Hyposafe hypoglycaemia alarm device.
- Performance: To evaluate the performance of the Hyposafe hypoglycaemia alarm device.
- Usability: To obtain information about the subjects use and acceptance of the Hyposafe Hypoglycaemia alarm device.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
18
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Esbjerg, Danmark, 6800
- Sydvestjysk Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Enhedens gennemførlighed
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Andet: Sydvestjysk Hospital
Investigation of EEG recording with the Hyposafe device
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Subcutaneous EEG recorder for EEG measurements
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Performance: EEG Recordings - Impedance
Tidsramme: 1 month
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The EEG performance was measured as the mean impedance as a function of time.
An impedance value below 5 kOhm is considered very good.
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1 month
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Performance: EEG Quality
Tidsramme: 1 month
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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
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1 month
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Performance: Continuous EEG
Tidsramme: 1 month
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Average time of EEG recordings (hours/day)
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1 month
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Usability: Reported Discomfort During Day While Wearing the Device
Tidsramme: 1 month
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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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1 month
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Usability: Reported Discomfort During Night While Wearing the Device
Tidsramme: 1 month
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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).
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1 month
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Usability: Reported Discomfort Related to the Implant in the Beginning of the Study
Tidsramme: 19±4 days after implantation
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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).
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19±4 days after implantation
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Usability: Reported Discomfort Related to the Implant at the End of the Study
Tidsramme: 51±3 days after implantation
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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).
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51±3 days after implantation
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Birger Thorsteinsson, MD, DMSc, Nordsjællands Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2014
Primær færdiggørelse (Faktiske)
1. januar 2017
Studieafslutning (Faktiske)
1. marts 2017
Datoer for studieregistrering
Først indsendt
18. marts 2015
Først indsendt, der opfyldte QC-kriterier
27. marts 2015
Først opslået (Skøn)
30. marts 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. september 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. september 2018
Sidst verificeret
1. september 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pilot 2_health_v2_August 27th
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