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

HEIDEGGER CP

Status: Completed

Conditions: Hypoglycemia; Protein Deficiency; Energy Supply; Deficiency, Severe; Hyperglycemia; Critical Illness

Treatments: Device: GLUCOSAFE 2; Device: Historical control group with routine care; Device: Local protocol control group with routine care

Study type: Interventional

Funder types: Other

Identifiers

NCT03890432

G2-0219

Details and patient eligibility

About

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.

Enrollment: 213 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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• Lack of legal consent or consent withdrawn, except for patients in the historical control group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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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213 participants in 3 patient groups

GLUCOSAFE 2

Experimental group

Description:

Insulin-therapy and nutrition support guided by the GLUCOSAFE 2 software.

Treatment:

Device: GLUCOSAFE 2

Local protocol control group

Active Comparator group

Description:

Insulin-therapy and nutrition support guided by the local protocols (electronic or paper version) of the ICU/HUG.

Treatment:

Device: Local protocol control group with routine care

Historical control group

Other group

Description:

Retrospective data with standard care before the beginning of the pilot study in order to minimize the "cross-over" effect due to the fact that caregivers are going to have in charge patients in both groups (intervention and control group) at the same time.

Treatment:

Device: Historical control group with routine care