Evaluation of the performance and safety of the intravascular ivCGM continuous glucose monitoring system in hospitalized patients in critical care units

Not Applicable

• Conditions: Hospitalized patients in cardiac surgery ICU.; E10; E11; Type 1 diabetes mellitus; Type 2 diabetes mellitus

• Registration Number: DRKS00027085
• Lead Sponsor: A. Menarini Diagnostics S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-11
• Study Completion: 2022-11-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 35

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

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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
- Total useful monitoring session duration (i.e. total time during which the system operated with no malfunctions during the experiment).<br>- Time-in-Range (TiR) and Area-under-the-curve (AUC) in the following ranges: <70 mg/dL (hypoglycaemic range), 70-180 mg/dL (euglycaemic ranges), >180 mg/dL (hyperglycaemic range).<br>- Number of hypoglycemic (< 70 mg/dL) and severe hypoglycemic (<40 mg/dL) episodes.<br>- Number of hyperglycemic (>180 mg/dL) episodes.<br>- Number of alarm/warning episodes vs actual glucose values.<br>- Scores evaluation of usability questionnaires compiled by users (system operators)