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

NCT03890432 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2025-08-12

No results posted yet for this study

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

DEVICE

GLUCOSAFE 2

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

DEVICE

Local protocol control group with routine care

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

DEVICE

Historical control group with routine care

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

Sponsors & Collaborators

  • Aalborg University

    collaborator OTHER

  • HEIDEGGER CP

    lead OTHER

Principal Investigators

  • Claudia P. Heidegger, MD · University Hospital, Geneva

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2025-01-26
Completion
2025-01-26

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03890432 on ClinicalTrials.gov