Hospitalized patients in cardiac surgery ICU. E10 E11
Conditions
Interventions
Group 1: At least 1/3 (and maximum 2/3) of the 35 patients suffer from a type 1 or type 2 mellitus. All patients will get an intravenous glucosesensor for continous glucose monitoring over 72 hours i
Sponsors
A. Menarini Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Hospitalized patients in cardiac surgery ICU. 2. Age >18 years 3. An understanding of and willingness to follow the study protocol and sign the informed consent 4. At least 10, maximum 20 with type 1 or type 2 diabetes
Exclusion criteria
Exclusion criteria: 1. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study 2. Any serious medical conditions or disability which, in the opinion of the investigator, would interfere with treatment or assessment or would preclude completion of the study 3. Pregnancy or breastfeeding 4. History of bleeding disorder 5. History of heparin-induced thrombocytopenia (HIT) 6. Significant acute or chronic illness that might interfere with patient safety or integrity of results as judged by the Investigator 7. Anemia with Hb < 7.5 g/dL 8. Known hypersensitivity to Fondaparinux sodium (Arixtra®) 9. Patient currently participating in an investigational clinical study that interferes with the execution of the study. 10. Absence of suitable vein for iv catheter and Probe insertion, as judged by the Investigator: (cephalic vein highly recommended; median antebrachial vein to be avoided; other veins to be chosen at Investigator’s discretion)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Absolute Relative Difference (MARD) of the glucose data obtained using the ivCGM system (calibrated using arterial or venous plasma samples measured with a reference instrument) compared to glucose reference values. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Total useful monitoring session duration (i.e. total time during which the system operated with no malfunctions during the experiment). - Time-in-Range (TiR) and Area-under-the-curve (AUC) in the following ranges: 180 mg/dL (hyperglycaemic range). - Number of hypoglycemic (180 mg/dL) episodes. - Number of alarm/warning episodes vs actual glucose values. - Scores evaluation of usability questionnaires compiled by users (system operators) | — |
Countries
Austria
Contacts
Public ContactJulia Mader
LKH Universitätsklinikum Graz Abteilung für Endokrinologie & Diabetologie
Outcome results
None listed