Healthy Subjects
Conditions
Interventions
Group 1: Study Visit A (Duration 24 h): n = 8 (minimum) - 28 (maximum)
The study will consist of two distinct procedures (A, and B), different for duration (24 or 72 hours) and number of subjects invo
Sponsors
A. Menarini Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained after being advised of the nature of the study 2. Male or female aged 18 - 75 years (both inclusive) 3. Healthy volunteer 4. Body mass index 20.0 - 29.5 kg/m² (both inclusive) 5. Availability of veins (within the forearms) suitable for insertion of three intravenous lines (two for microdialysis sampling and one for reference blood withdrawal).
Exclusion criteria
Exclusion criteria: 1. Female of childbearing potential who is pregnant, breast-feeding or intending to become pregnant or is not using adequate contraceptive methods 2. Skin pathology or condition prohibiting needle insertion as judged by the Investigator 3. History of bleeding disorder 4. History of heparin-induced thrombocytopenia (HIT) 5. Current participation in another clinical study 6. Significant acute or chronic illness that might interfere with subject safety or integrity of results as judged by the Investigator 7. Drugs which have an influence on glucose metabolism such as: systemic (oral or i.v.) corticosteroids, anticoagulation medication, monoamine oxidase (MAO) inhibitors or paracetamol. Thyroid hormones are not allowed unless the use of these has been stable during the past 1 month. 8. Blood donation or blood loss of more than 500 mL within 12 weeks prior to the study day 9. Known hypersensitivity to Fondaparinux sodium (Arixtra ®) 10. Significant history of alcoholism or drug abuse or a positive result in urine drug/alcohol screen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment and optimization of the glucose recovery performance (absolute value and stability over time) of modified versions of the MicroEye® probe, using an intravascular microdialysis approach in healthy volunteers. To this aim, the effect of both different probe designs (differing for length of microdialysis membrane) and different anticoagulant concentrations (obtained by injection into the Perfusion solution bag) will be explored. The samples obtained from intravenous microdialysis will be continuously collected in microtubes at 15 min intervals for the first three hours and then once every hour for the remaining period. Each microtube will be weighted in order to confirm the perfusion solution flow rate and then analyzed for glucose using the YSI glucose analyzer. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Optimize the calibration procedure for an intravascular microdialysis-based CGM (continuous glucose monitoring) system. - Assess the reliability of the device. - Evaluate safety and tolerability of the Probe using an intravascular microdialysis approach in healthy volunteers. | — |
Countries
Austria
Contacts
Public ContactTamara Esterl
Division of Endocrinology and DiabetologyDept. of Internal MedicineMedical University of Graz
Outcome results
None listed