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

NCT03890432 | Completed

• 1 other identifier: G2-0219
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 2

Brief 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

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

Keywords

Nutrition management; Glycaemia control; ICU; Software; Critical illness; Insulin-therapy; Critically ill patients; Blood glucose control

Outcome Measures

Primary Outcomes (1)

• Time-in-target (range: 5.0 - 8.5 mmol/l)

  Time spent in the glycaemia range of 5.0 - 8.5 mmol/l per day, per patient and in the cohort

  During ICU stay, up to 15 days post-randomization.

Secondary Outcomes (20)

• Overall number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events

  During ICU stay, up to 15 days post-randomization.

• Overall percentage of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events

  During ICU stay, up to 15 days post-randomization.

• Number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events due to non-compliance

  During ICU stay, up to 15 days post-randomization.

• Percentage of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events due to non-compliance

  During ICU stay, up to 15 days post-randomization.

• Time to normalize blood glucose (5.0-8.5 mmol/l)

  During ICU stay, up to 15 days post-randomization.

Study Arms (3)

GLUCOSAFE 2

EXPERIMENTAL

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

Device: GLUCOSAFE 2

Local protocol control group

ACTIVE COMPARATOR

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

Device: Local protocol control group with routine care

Historical control group

OTHER

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.

Device: Historical control group with routine care

Interventions

GLUCOSAFE 2 DEVICE

Use of GLUCOSAFE 2 software for nutrition management and insulin-therapy

GLUCOSAFE 2

Local protocol control group with routine care DEVICE

Use of the local protocols (electronic or paper version) for nutrition management and blood glucose control.

Local protocol control group

Historical control group with routine care DEVICE

Use of the local protocols (electronic or paper version) for nutrition management and blood glucose control.

Historical control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HEIDEGGER CP: lead
• Aalborg University: collaborator

Study Sites (2)

Hôpitaux Universitaire de Genève

Geneva, Canton of Geneva, 1205, Switzerland

Location

Service of Intensive Care, Geneva University Hospital,

Geneva, Canton of Geneva, 1211, Switzerland

Location

Related Publications (1)

• de Watteville A, Pielmeier U, Di Marco M, Gayet-Ageron A, Siegenthaler N, Parel N, Wozniak H, Primmaz S, Pugin J, Andreassen S, Heidegger CP. Glucosafe 2-A new tool for nutritional management and insulin-therapy in the intensive care unit: Randomized controlled study (the Glucosafe 2 protocol). PLoS One. 2025 Mar 4;20(3):e0316624. doi: 10.1371/journal.pone.0316624. eCollection 2025.

  PMID: 40036206 DERIVED

MeSH Terms

Conditions

Critical Illness; Protein Deficiency; Hypoglycemia; Hyperglycemia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Claudia P. Heidegger, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Privat-Docent, Senior Lecturer

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: March 26, 2019
• Study Start: January 10, 2023
• Primary Completion: January 26, 2025
• Study Completion: January 26, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

CH (2)