Clinical Trials Directory

Trials / Completed

CompletedNCT03890432

GLUCOSAFE 2 - A New Tool for Nutritional Management and Insulin-therapy in the Intensive Care Unit (ICU)

GLUCOSAFE 2 - A New Tool for Nutritional Management and Insulin-therapy in the Intensive Care Unit (ICU): Randomized Controlled Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
213 (actual)
Sponsor
HEIDEGGER CP · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The survival and the outcomes of critically ill patients are strongly influenced by insulin-therapy and nutritional support. The GLUCOSAFE 2 pilot study, aims to test the performance and the security of the new GLUCOSAFE 2 software, developed by the model-based medical decision support of Aalborg University (Denmark) and adapted to the clinical needs in the intensive care unit (ICU) of the Geneva University Hospital (HUG). This new device is based on a mathematical model of the glucose-insulin metabolism and attempts to give advices for better glycaemia control and nutritional therapy. The GLUCOSAFE 2 study hypothesizes that the use of the Glucosafe 2 software will allow better glycaemia ("Time-in-target") control and better achievement of nutritional energy and protein targets in comparison to the local protocols.

Conditions

Interventions

TypeNameDescription
DEVICEGLUCOSAFE 2Use of GLUCOSAFE 2 software for nutrition management and insulin-therapy
DEVICELocal protocol control group with routine careUse of the local protocols (electronic or paper version) for nutrition management and blood glucose control.
DEVICEHistorical control group with routine careUse of the local protocols (electronic or paper version) for nutrition management and blood glucose control.

Timeline

Start date
2023-01-10
Primary completion
2025-01-26
Completion
2025-01-26
First posted
2019-03-26
Last updated
2025-08-12

Locations

2 sites across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT03890432. Inclusion in this directory is not an endorsement.