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

25. september 2018 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

  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.

Studietype

Intervensjonell

Registrering (Faktiske)

18

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Danmark
      • Esbjerg, Danmark, 6800
        • Sydvestjysk Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Enhetens gjennomførbarhet
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Sydvestjysk Hospital
Investigation of EEG recording with the Hyposafe device
Enhet: Hyposafe device
Subcutaneous EEG recorder for EEG measurements

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Performance: EEG Recordings - Impedance
Tidsramme: 1 month
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
Tidsramme: 1 month
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
Tidsramme: 1 month
Average time of EEG recordings (hours/day)
1 month

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Usability: Reported Discomfort During Day While Wearing the Device
Tidsramme: 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).
1 month
Usability: Reported Discomfort During Night While Wearing the Device
Tidsramme: 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).
1 month
Usability: Reported Discomfort Related to the Implant in the Beginning of the Study
Tidsramme: 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).
19±4 days after implantation
Usability: Reported Discomfort Related to the Implant at the End of the Study
Tidsramme: 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).
51±3 days after implantation

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

UNEEG Medical A/S

Etterforskere

  • Hovedetterforsker: Birger Thorsteinsson, MD, DMSc, Nordsjællands Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2014

Primær fullføring (Faktiske)

1. januar 2017

Studiet fullført (Faktiske)

1. mars 2017

Datoer for studieregistrering

Først innsendt

18. mars 2015

Først innsendt som oppfylte QC-kriteriene

27. mars 2015

Først lagt ut (Anslag)

30. mars 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. september 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. september 2018

Sist bekreftet

1. september 2018

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Pilot 2_health_v2_August 27th

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