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

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.

Inclusion Criteria:

All patients ≥ 18 years admitted to the ICU with

• An expected length of stay ≥ 72h
• At least 1 blood glucose (BG) measurement ≥10 mmol/l or 2 BG measurement ≥ 8.5 mmol/l
• Informed Consent signed by the subject/ legal representative, except for patients in the historical control group

Exclusion Criteria:

• Lack of legal consent or consent withdrawn, except for patients in the historical control group
• Pregnant or breast feeding
• Diabetic ketoacidosis or hyperosmolar state
• Oral feeding
• Fulminant hepatic failure
• Medically contraindicated to receive rapidly acting insulin by intravenous (iv) infusion or iv injection