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Prospective bi -centric open pilot study to investigate the functionality of blood glucose control with the SGCplus system in intensive care unit patients

Prospective bi -centric open pilot study to investigate the functionality of blood glucose control with the SGCplus system in intensive care unit patients - ICONIA

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
DRKS
Registry ID
DRKS00011117
Enrollment
25
Registered
2016-09-23
Start date
2016-11-02
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In this trial the functionality of blood glucose control with the SGCplus system in intensive care unit patients is being investigated.

Interventions

Group 1: The SGCplus system will be connected to the arterial line
periodically the blood glucose levels will be determined ( max . 12 times per day at max . 12 consecutive days ) Group 2: Through the arterial line blood samples of 0.5 ml will be collected periodical
further a blood glucose measurements with the Radiometer ABL 90 FLEX (ICU Analyzer)- for reference and for calibration of the SGCplus system (max. 12 blood samples per day at max. 12 consecutive days)

Sponsors

B. Braun Melsungen AG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age: = 18 years of age; Patients requiring arterial catheter as judged by the treating physician; Patients requiring i. v. insulin treatment as judged by the treating physician.

Exclusion criteria

Exclusion criteria: Female who is pregnant or breast-feeding; Known or suspected allergy to insulin; Participation in another intervention trial during the study.

Design outcomes

Primary

MeasureTime frame
To investigate the functionality of the SGC plus sytem in ICU patients with primary focus on the incidence of calibrations which will be demanded by the system

Secondary

MeasureTime frame
To investigate usability, performance, accuracy and saftey of the SGCplus system in ICU patients evaluated by a user questionnaire

Countries

Austria

Contacts

Public ContactJulia Mader

Univ. Klinik für Innere Medizin, Abteilung für Endokrinologie und Diabetologie

julia.mader@medunigraz.at+ 43 316 385 80254

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026