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NCT Number: NCT03890432

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

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.

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Key information

Conditions

Critical Illness Deficiency Diseases Disease Attributes Energy Supply; Deficiency, Severe Glucose Metabolism Disorders Hyperglycemia Hypoglycemia Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Protein Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpitaux Universitaire de Genève, Geneva, Canton of Geneva, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Lack of legal consent or consent withdrawn, except for patients in the historical control group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

Treatment and study plan

GLUCOSAFE 2

Device

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

Local protocol 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 with routine care

Device

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

Primary outcomes

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

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

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

Secondary outcomes

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

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

    Overall number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events (per patient and in the cohort)

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

    Time frame: 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 (per patient and in the cohort)

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

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

    Overall number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events due to non-compliance (only in intervention arm)

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

    Time frame: 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 (only in intervention arm)

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

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

    Three values < 8.5 mmol/l as indicator for normalization

  6. Percentage of time in the ICU (per patient and in the cohort) with hyperglycaemia (BG > 8.5 mmol/l)

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

    Percentage of time with BG > 8.5 mmol/l before and after normalization per patient and in the cohort.

  7. Percentage of time in the ICU (per patient and in the cohort) with hyperglycaemia (BG > 8.5 mmol/l) due to non compliance

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

    Percentage of time with BG > 8.5 mmol/l before and after normalization per patient and in the cohort due to non compliance (only in the intervention arm).

  8. Number of hyperglycemic episodes after normalization (> 8.5 mmol/l)

    Time frame: From normalization time during ICU stay, up to 15 days post-randomization.

    Three values < 8.5 mmol/h as indicator for normalization

  9. Number of hyperglycemic episodes after normalization (> 8.5 mmol/l) due to non compliance

    Time frame: From normalization time during ICU stay, up to 15 days post-randomization.

    Three values < 8.5 mmol/h as indicator for normalization

  10. Number of episodes (per patient and in the cohort) where a BG measurements is not followed up within 30 minutes by a request for Glucosafe 2 advice

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

    Number of episodes (per patient and in the cohort) where a BG measurements is not followed up within 30 minutes by a request for Glucosafe 2 advice

  11. Number of episodes (per patient and in the cohort) where pumps were not set within 30 min according to Glucosafe2 advice accepted by the nurse.

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

    Number of episodes (per patient and in the cohort) when pumps were not set within 30 min according to Glucosafe2 advice accepted by the nurse.

  12. Number of advices given by GS2 which were accepted, accepted with modification, or rejected.

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

    Number of advices given by GS2 which were accepted, accepted with modification, or rejected.

  13. Frequency of daily and cumulated BG measurements per patient and in the cohort

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

    Frequency of BG measurements (per patient and in the cohort)

  14. Frequency of daily and cumulated adjustments of insulin and nutrition pump settings (per patient and in the cohort)

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

    Frequency of daily and cumulated adjustments of insulin and nutrition pump settings (per patient and in the cohort)

  15. Glycaemic variability

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

    Mean and standard deviation (SD) of blood glucose measurements. Daily maximum blood glucose difference.

  16. Protein goal achievements (80-100% of accumulated target) with a target of 1.3 g/kg of body weight per day.

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

    Percentage of proteins received per day and at the end of the ICU stay with a target of 1.3 g/kg of body weight per day.

  17. Caloric goal achievements (80-100% of the accumulated target) by indirect calorimetry (IC) or predictive formula if IC not feasible.

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

    Percentage of nutritional and non-nutritional calories received per day and at the end of the ICU stay with a target defined by IC or predictive formula if IC not feasible.

  18. Energy debt: difference between the defined energy target (80-100%, defined by IC or predictive formula) and the energy received (nutritional and non-nutritional)

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

    Per day and at the end of the ICU stay.

  19. Protein debt: difference between the defined protein target (1.3 g/kg of body weight/day) and the proteins received

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

    Per day and at the end of the ICU stay.

  20. Prediction of BG

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

    Prediction error as a function of time elapsed since last BG measurement, per patient, per cohort.measurement (per patient and per cohort).

Sponsors and collaborators

Lead sponsor

HEIDEGGER CP

Other

Collaborators

  • Aalborg University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 26, 2019
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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