Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890432
Recruitment Status : Not yet recruiting
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
Aalborg University
Information provided by (Responsible Party):
HEIDEGGER CP, University Hospital, Geneva

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.

Condition or disease Intervention/treatment Phase
Critical Illness Energy Supply; Deficiency, Severe Protein Deficiency Hypoglycemia Hyperglycemia Device: GLUCOSAFE 2 Device: Local protocol control group with routine care Device: Historical control group with routine care Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: GLUCOSAFE 2 - A New Tool for Nutritional Management and Insulin-therapy in the Intensive Care Unit: a Pilot Randomized Controlled Trial
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: GLUCOSAFE 2
Insulin-therapy and nutrition support guided by the GLUCOSAFE 2 software.
Device: GLUCOSAFE 2
Use of GLUCOSAFE 2 software for nutrition management and insulin-therapy

Active Comparator: Local protocol control group
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
Use of the local protocols (electronic or paper version) for nutrition management and blood glucose control.

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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Overall number of severe hypoglycemia events (<3.0 mmol/l) [ Time Frame: During ICU stay, up to 15 days post-randomization. ]
    Overall number of severe hypoglycemia events <3.0 mmol/l (per patient and in the cohort)

  2. Overall percentage of severe hypoglycemia events (<3.0 mmol/l) [ Time Frame: During ICU stay, up to 15 days post-randomization. ]
    Overall percentage of severe hypoglycemia events <3.0 mmol/l (per patient and in the cohort)

  3. Number of severe hypoglycemia events (<3.0 mmol/l) due to workflow errors [ Time Frame: During ICU stay, up to 15 days post-randomization. ]
    Overall number of severe hypoglycemia events <3.0 mmol/l (per patient and in the cohort) due to workflow errors

  4. Percentage of severe hypoglycemia events (<3.0 mmol/l) due to workflow errors [ Time Frame: During ICU stay, up to 15 days post-randomization. ]
    Overall percentage of severe hypoglycemia events <3.0 mmol/l (per patient and in the cohort) due to workflow errors

  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 episodes (per patient and in the cohort) when BG measurements are not followed (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) when BG measurements are not followed (within 30 minutes) by a request for Glucosafe 2 advice.

  10. Number of episodes (per patient and in the cohort) when pumps are not set (within 30 min) according to Glucosafe2 advice. [ Time Frame: During ICU stay, up to 15 days post-randomization. ]
    Number of episodes (per patient and in the cohort) when pumps are not set (within 30 min) according to Glucosafe2 advice.

  11. Frequency of 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)

  12. Frequency of insulin adjustments and nutrition pump settings (per patient and in the cohort) [ Time Frame: During ICU stay, up to 15 days post-randomization. ]
    Frequency of insulin adjustments and nutrition pump settings (per patient and in the cohort)

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. Prediction of BG [ Time Frame: During ICU stay, up to 15 days post-randomization. ]
    Root mean squared prediction error as a function of time elapsed since last BG measurement (per patient and per cohort).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All patients ≥ 18 years admitted to the ICU with

  • an expected length of stay ≥ 76h and
  • at least 1 blood glucose (BG) measurement ≥10 mmol/l or 2 BG measurements ≥ 8.5 mmol/l
  • starting nutrition support (enteral nutrition (EN) or parenteral nutrition (PN)).

Exclusion Criteria:

  • Pregnant or breast feeding
  • Diabetic ketoacidosis or hyperosmolar state on admission
  • Oral feeding
  • Fulminant hepatic failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890432


Contacts
Layout table for location contacts
Contact: Claudia P. Heidegger, MD + 41 22 37 27 440 claudia.heidegger@hcuge.ch
Contact: Aude De Watteville, Bsc + 41 79 55 33 998 aude.dewatteville@hcuge.ch

Locations
Layout table for location information
Switzerland
Service of Intensive Care, Geneva University Hospital,
Geneva, Switzerland, 1211
Contact: Claudia Heidegger, MD       claudia.heidegger@hcuge.ch   
Contact: Aude De Watteville, Bsc       aude.dewatteville@hcuge.ch   
Sponsors and Collaborators
HEIDEGGER CP
Aalborg University
Investigators
Layout table for investigator information
Principal Investigator: Claudia P. Heidegger, MD University Hospital, Geneva
Layout table for additonal information
Responsible Party: HEIDEGGER CP, Privat-Docent, Senior Lecturer, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03890432    
Other Study ID Numbers: G2-0219
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HEIDEGGER CP, University Hospital, Geneva:
Nutrition management
Glycaemia control
ICU
Software
Critical illness
Insulin-therapy
Critically ill patients
Blood glucose control
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypoglycemia
Hyperglycemia
Protein Deficiency
Critical Illness
Glucose Metabolism Disorders
Metabolic Diseases
Disease Attributes
Pathologic Processes
Deficiency Diseases
Malnutrition
Nutrition Disorders