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Performance Evaluation of a Novel Non-invasive Glucometer, Calibrated Against Validated Interstitial Glucose References

11. desember 2019 oppdatert av: RSP Systems A/S
This clinical study has been launched to collect spectral Raman data on the Investigational Medical Device (IMD) compared with reference methods in terms of interstitial fluid samples and capillary and venous references.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Subjects will visit the clinic for a baseline visit and two in-clinic visits. On in-clinic days, subjects will attend the clinic in a fasting state. They will have inserted a Dexcom and Freestyle Libre and a microdialysis catheter. At time = 0, subjects will be administered a glucose rich drink and every 6. minut measurements will be performed. These include a measurement on the IMD, microdialysate, FreeStyle Libre and Dexcom readings. Every 18. minut a venous blood sample will be included and every 36. minut a capillary blood sample will be collected. This continues until time = 180 minutes.

Studietype

Intervensjonell

Registrering (Faktiske)

12

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Sverige
      • Gothenburg, Sverige
        • Gothia Forum för Klinisk Forskning, Sahlgrenska Universitetssjukhuset

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

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Male and female subjects 18-70 years old
  • Patients diagnosed with type 1 or type 2 diabetes (T1D or T2D) (insulin requiring T2D patients)
  • Diabetes management strategy: lifestyle regimen + insulin ± oral hypoglycemic agents
  • Skin phototype 1-4

Exclusion Criteria:

  • For female participants: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
  • > 10 cigarettes pr. day
  • Participants not able to understand and read Swedish
  • In investigator's opinion, participant is not able to follow instructions as specified in the protocol
  • Participants not able to hold hand/arm steadily (including tremors and Parkinson's Disease)
  • Diagnosed with reduced circulation
  • Extensive skin changes, tattoos or diseases on probe application site
  • Rejection by screening optical measurements
  • Known allergy to medical grade alcohol
  • Known allergy to adhesives
  • Systemic or topical administration of glucocorticoids for the past 7 days
  • Participants undergoing dialysis treatment
  • Anti-coagulation or anti-platelet therapy
  • Use of beta-blockers
  • Medical conditions causing bleeding tendency
  • Medical history or any condition that may, in the opinion of the investigator, compromise the subject's ability to participate
  • Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff. Such conditions include but are not limited to HIV and Hepatitis B or C.
  • Participants currently enrolled in another study

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
Eksperimentell: RSP-08
All subjects undergo the same procedures. Subjects will be subjected to measurements on the IMD (Working Model 3.4NR), FreeStyle Libre, Dexcom, microdialysis, venous and capillary blood collection.
Enhet: Working Model 3.4NR
Investigational Medical Device collecting spectral Raman data from tissue

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Generation and validation of prediction models - MARD
Tidsramme: One year

Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected.

Optical glucose readings will be masked to the subjects.

Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Mean Absolute Relative Difference (MARD) endpoint measure.
One year
Generation and validation of prediction models - ISUP
Tidsramme: One year

Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected.

Optical glucose readings will be masked to the subjects.

Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Inter Subject Unified Performance (ISUP) measure.
One year
Generation and validation of prediction models - Consensus Error Grid
Tidsramme: One year

Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected.

Optical glucose readings will be masked to the subjects.

Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Consensus Error Grid Analysis
One year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Evaluation of dynamics between arterial and venous glucose profiles in relation to interstitial glucose levels
Tidsramme: One year

Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected.

Optical glucose readings will be masked to the subjects.

A modeling-based evaluation of the dynamics between blood glucose and tissue glucose will be conducted and serve as a secondary endpoint of the study.
One year
Safety evaluation: paucity of adverse events
Tidsramme: One year
Safety will be evaluated in a descriptive manner by the paucity of adverse events
One year

Samarbeidspartnere og etterforskere

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

Sponsor

RSP Systems A/S

Etterforskere

  • Hovedetterforsker: Per-Anders Jansson, MD, Sahlgrenska Universitetssjukhuset, Gothenburg

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 (Faktiske)

29. november 2018

Primær fullføring (Faktiske)

19. juni 2019

Studiet fullført (Faktiske)

19. juni 2019

Datoer for studieregistrering

Først innsendt

3. desember 2018

Først innsendt som oppfylte QC-kriteriene

18. desember 2018

Først lagt ut (Faktiske)

20. desember 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. desember 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. desember 2019

Sist bekreftet

1. desember 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • RSP-08

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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