- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01198678
Feasibility Study to Assess the Safety and Functionality of the GluSense Continuous Glucose Monitor in Diabetic Patients
Feasibility Study to Assess the Safety and Functionality of the GluSense-LTone 2e3 Continuous Glucose Monitor in Diabetic Patients
Currently marketed CGM sensors have an approved functional lifetime of up to 1 week. Pre-clinical studies have demonstrated that GluSense-LTone 2e3 sensors may be used to accurately monitor glucose levels for 30 days. The purpose of this study is to assess the safety and functionality of the device in human patients for consecutive 15 days.
GluSense-LTone 2e3 as long term CGM, will require less sensor replacements and calibration, meaning less patient interventions, and is therefore will be much more user friendly. Moreover, GluSense-LTone 2e3 shows potentially increased accuracy, especially in the critically important hypoglycemic range, meaning that better management of patient's condition may be attained.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
-
Ljubljana, Slovenia, SI-1000
- University Medical Center Ljubljana
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
- Male or female patients between 18 and 50 years of age
- Patients with type 1 diabetes mellitus.
- The ability to read, understand and sign an informed consent form. Written consent must be obtained prior to initiation of study procedures
Exclusion Criteria:
Patients who meet any of the following exclusion criteria are not to be enrolled in this study:
Clinical significant illness that can compromise patient's health during study such as:
- Significant current heart disease
- Significant Liver or kidney disease
- HIV infection
- Hepatitis B or Hepatitis C infection
- Malignancy
- Major allergic skin disease including plaster allergies
- Significant allergic disorders
- Current or recent significant skin conditions (e.g. eczema, psoriasis,).
- Presence of skin markings/ abnormalities around implantation site that will interfere with the skin assessment e.g. tattoos, piercings, birthmark, sunburn
- Current alcohol or substance use judged by the IP to potentially interfere with patient study compliance.
- Routine administration of Steroid based medications.
- Patients currently taking part in any other clinical trial using an investigational product within the last 3 months
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Evaluate capability to follow glucose concentration changes over 15 consecutive days
Tidsramme: 3 weeks
|
3 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Tadej Batellino, Prof, University Medical Centre Ljubljana
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- Slovenia-UMC-001
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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