Healthy subjects
Conditions
Interventions
Group 1: Sampling of dermal interstitial fluid for 30 hours using the OFM-System with different operation-parametres.
Sponsors
Universitätsklinik für Innere Medizin, Abteilung für Endokrinologie und Diabetologie
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years to = 50 years 2. Healthy subjects 3. Ability to read, understand and sign informed consent form
Exclusion criteria
Exclusion criteria: 1. Pregnancy, nursing period or planned pregnancy 2. Known infectious diseases past or present (HIV, Hepatitis B,C) 3. Coagulation disorder or oral anticoagulation therapy 4. Autoimmune dermatoses 5. Known needle phobia 6. Known wound healing disorder e.g. keloid formation 7. Recurring thromboses or known genetic tendency towards thromboses (e.g. APC resistance) 8. Severe acute and/or chronic disease (judged by investigator). 9. Mental incapability, unwillingness or language barriers, which impede or complicate the understanding of the ICF and the necessay cooperation. 10. Known allergy to plasters or adhesive parts of the OFM-System. 11. Any abnormal, clinically significant Screening result which leads to exclusion as judged by the investigator. 12. Tattoos or damaged skin at the application Areas. 13. Active skin disease e.g. Psoriasis or atopic dermatitis (judged by investigator).
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| objectively measured as sample-volume stability for the fractions/time via coefficient of variation [% coefficient of variation, comparison of mean values ± Standard deviation] in reliance on operation parametres objectively measured as glucose-recovery stability relative to blood glucose for the fractions/time via coefficient of variation [% coefficient of variation, comparison of mean values ± Standard deviation] in reliance on operation parametres | — |
Primary
| Measure | Time frame |
|---|---|
| Functionality and Efficiency of the OFM-System for the duration of 30 hours objectively measured via sample-volume gained [µL, comparison of mean values ± Standard deviation] in reliance on operation parametres | — |
Countries
Austria
Contacts
Public ContactGerd Schwagerle
Medizinische Universität Graz,Clinical Research Center
Outcome results
None listed