Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device and Evaluation of the Instructions for Use
6. oktober 2020 oppdatert av: RSP Systems A/S
The aim of the study is to demonstrate the safety and performance of a novel non-invasive glucose monitoring device, to collect data and reference measurements for establishment of calibration models and to evaluate the instructions for use for the device.
This study will be an explorative study with 10 study subjects.
Studieoversikt
Detaljert beskrivelse
The Investigational Medical Device (IMD) for this investigation is the Prototype 0.5 (P0.5) developed and manufactured by RSP Systems (RSP).
The device is intended for non-invasive interstitial intermittent glucose monitoring in persons (age 18 and older) with diabetes.
The technology relies on the well-established capacities of Raman spectroscopy for directly detecting glucose subcutaneously.
The Raman spectroscopy physical principle relies on the fact that when laser light of a given wavelength interferes with a molecule, a small fraction of the incident light will interact with the vibrational states of the molecule, causing the photons to lose a portion of their energy which will change the wavelength of the light.
The scattered light will be collected by the optical probe head and analyzed with advanced algorithms to correlate the signal to glucose concentrations.
Data collected from the IMD will be paired with validated glucose reference values collected by the finger sticking method.
Studietype
Intervensjonell
Registrering (Faktiske)
10
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Ulm, Tyskland, 89081
- Institut für Diabetes-Technologie Forschungs- und Entwicklungs-gesellschaft mbH an der Universität Ulm (IDT)
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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
1 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Male and female subjects ≥18 years of age
- Individuals diagnosed with type 1 diabetes. Gestational diabetes excluded
- Skin phototype 1-4
- Willing to perform up to 12 finger sticks during each day of out-patient measurements and up to 40 finger sticks at the two in-clinic study days
- Wireless internet connection at home to be used in the study
Exclusion Criteria:
- For female subjects: Pregnancy or subject is attempting to conceive or not willing and able to practice NCA approved birth control during the study duration
- For female subjects: breastfeeding
- Subjects currently participating in another study
- Subjects not able to understand and read German
- In investigator's opinion, subject is not able to follow instructions provided and as specified in the protocol
- Subject not able to hold hand/arm steady (including tremors and Parkinson's Disease)
- Extensive skin changes, tattoos or diseases on right hand thenar (sensor application site)
- Known allergy to medical grade alcohol
- Hemodialysis
- Systemic or topical administration of glucocorticoids at the right hand for the past 7 days or during the study period expected
- Medical history or any condition that may, in the opinion of the investigator compromise the subject's ability to participate
- Comorbidity or concomitant medical condition which, in the opinion of the Investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff
- Severe diabetes related complications such as advanced autonomic neuropathy, kidney disease, foot ulcers, legal blindness, or symptomatic cardiovascular disease as evidenced by a history of cardiovascular episode(s)
- Dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor, the study site, and/ or their families)
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
- Hypoglycemia unawareness
- Subjects who have participated in the study IDT-1639-RO
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: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Protocol 1
RSP-21 Subjects will perform daily measurements on the IMD (Prototype 0.5) in addition to capillary reference measurements for 41 days.
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Subjects will perform daily measurements on the IMD (Prototype 0.5) for 41 days.
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Eksperimentell: Protocol 2
RSP-21 Subjects will perform daily measurements on the IMD (Prototype 0.5) in addition to capillary reference measurements for 41 days. One group of subjects will receive training in the use of the device the other will not. Both groups will receive the instructions for use. |
Subjects will perform daily measurements on the IMD (Prototype 0.5) for 41 days.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Measurement accuracy
Tidsramme: 4 months
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Accuracy of measurements performed on the IMD will be evaluated by data from subjects.
Data will be analyzed by Mean Absolute Relative Difference (MARD).
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4 months
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Risk/benefit analysis
Tidsramme: 4 months
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Risk/benefit analysis based on reported Adverse Device Effects and Serious Adverse Device Effects and the clinical performance safety profile.
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4 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Review of IFU based on clinical performance.
Tidsramme: 4 months
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Adequacy of IFU will be evaluated based on differences in clinical performance in two groups with and without personal training.
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4 months
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Review of IFU based on number of safety events.
Tidsramme: 4 months
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Adequacy of IFU will be evaluated based on differences in safety events in two groups with and without personal training.
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4 months
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Number of encountered Device Deficiencies
Tidsramme: 4 months
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Evaluation of device function with respect to identity, quality, durability, reliability, safety and performance
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4 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Guido Freckman, IfDT
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)
18. september 2019
Primær fullføring (Faktiske)
31. oktober 2019
Studiet fullført (Faktiske)
31. oktober 2019
Datoer for studieregistrering
Først innsendt
15. juli 2019
Først innsendt som oppfylte QC-kriteriene
24. juli 2019
Først lagt ut (Faktiske)
25. juli 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. oktober 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. oktober 2020
Sist bekreftet
1. oktober 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- RSP-21
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. .