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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
GLUCOSAFE 2
Local protocol control group with routine care
Historical control group with routine care
Sponsored by
HEIDEGGER CP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Nutrition management, Glycaemia control, ICU, Software, Critical illness, Insulin-therapy, Critically ill patients, Blood glucose control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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  • Lack of legal consent or consent withdrawn, except for patients in the historical control group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

Sites / Locations

  • Hôpitaux Universitaire de GenèveRecruiting
  • Service of Intensive Care, Geneva University Hospital,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

GLUCOSAFE 2

Local protocol control group

Historical control group

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events
Overall number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events (per patient and in the cohort)
Overall percentage of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events
Overall percentage of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events (per patient and in the cohort)
Number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events due to non-compliance
Overall number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events due to non-compliance (only in intervention arm)
Percentage of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events due to non-compliance
Percentage of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events due to non-compliance (only in intervention arm)
Time to normalize blood glucose (5.0-8.5 mmol/l)
Three values < 8.5 mmol/l as indicator for normalization
Percentage of time in the ICU (per patient and in the cohort) with hyperglycaemia (BG > 8.5 mmol/l)
Percentage of time with BG > 8.5 mmol/l before and after normalization per patient and in the cohort.
Percentage of time in the ICU (per patient and in the cohort) with hyperglycaemia (BG > 8.5 mmol/l) due to non compliance
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).
Number of hyperglycemic episodes after normalization (> 8.5 mmol/l)
Three values < 8.5 mmol/h as indicator for normalization
Number of hyperglycemic episodes after normalization (> 8.5 mmol/l) due to non compliance
Three values < 8.5 mmol/h as indicator for normalization
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
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
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.
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.
Number of advices given by GS2 which were accepted, accepted with modification, or rejected.
Number of advices given by GS2 which were accepted, accepted with modification, or rejected.
Frequency of daily and cumulated BG measurements per patient and in the cohort
Frequency of BG measurements (per patient and in the cohort)
Frequency of daily and cumulated adjustments of insulin and nutrition pump settings (per patient and in the cohort)
Frequency of daily and cumulated adjustments of insulin and nutrition pump settings (per patient and in the cohort)
Glycaemic variability
Mean and standard deviation (SD) of blood glucose measurements. Daily maximum blood glucose difference.
Protein goal achievements (80-100% of accumulated target) with a target of 1.3 g/kg of body weight per day.
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.
Caloric goal achievements (80-100% of the accumulated target) by indirect calorimetry (IC) or predictive formula if IC not feasible.
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.
Energy debt: difference between the defined energy target (80-100%, defined by IC or predictive formula) and the energy received (nutritional and non-nutritional)
Per day and at the end of the ICU stay.
Protein debt: difference between the defined protein target (1.3 g/kg of body weight/day) and the proteins received
Per day and at the end of the ICU stay.
Prediction of BG
Prediction error as a function of time elapsed since last BG measurement, per patient, per cohort.measurement (per patient and per cohort).

Full Information

First Posted
February 14, 2019
Last Updated
March 23, 2023
Sponsor
HEIDEGGER CP
Collaborators
Aalborg University
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1. Study Identification

Unique Protocol Identification Number
NCT03890432
Brief Title
GLUCOSAFE 2 - A New Tool for Nutritional Management and Insulin-therapy in the Intensive Care Unit (ICU)
Official Title
GLUCOSAFE 2 - A New Tool for Nutritional Management and Insulin-therapy in the Intensive Care Unit (ICU): Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
HEIDEGGER CP
Collaborators
Aalborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
213 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GLUCOSAFE 2
Arm Type
Experimental
Arm Description
Insulin-therapy and nutrition support guided by the GLUCOSAFE 2 software.
Arm Title
Local protocol control group
Arm Type
Active Comparator
Arm Description
Insulin-therapy and nutrition support guided by the local protocols (electronic or paper version) of the ICU/HUG.
Arm Title
Historical control group
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
GLUCOSAFE 2
Intervention Description
Use of GLUCOSAFE 2 software for nutrition management and insulin-therapy
Intervention Type
Device
Intervention Name(s)
Local protocol control group with routine care
Intervention Description
Use of the local protocols (electronic or paper version) for nutrition management and blood glucose control.
Intervention Type
Device
Intervention Name(s)
Historical control group with routine care
Intervention Description
Use of the local protocols (electronic or paper version) for nutrition management and blood glucose control.
Primary Outcome Measure Information:
Title
Time-in-target (range: 5.0 - 8.5 mmol/l)
Description
Time spent in the glycaemia range of 5.0 - 8.5 mmol/l per day, per patient and in the cohort
Time Frame
During ICU stay, up to 15 days post-randomization.
Secondary Outcome Measure Information:
Title
Overall number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events
Description
Overall number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events (per patient and in the cohort)
Time Frame
During ICU stay, up to 15 days post-randomization.
Title
Overall percentage of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events
Description
Overall percentage of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events (per patient and in the cohort)
Time Frame
During ICU stay, up to 15 days post-randomization.
Title
Number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events due to non-compliance
Description
Overall number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events due to non-compliance (only in intervention arm)
Time Frame
During ICU stay, up to 15 days post-randomization.
Title
Percentage of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events due to non-compliance
Description
Percentage of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events due to non-compliance (only in intervention arm)
Time Frame
During ICU stay, up to 15 days post-randomization.
Title
Time to normalize blood glucose (5.0-8.5 mmol/l)
Description
Three values < 8.5 mmol/l as indicator for normalization
Time Frame
During ICU stay, up to 15 days post-randomization.
Title
Percentage of time in the ICU (per patient and in the cohort) with hyperglycaemia (BG > 8.5 mmol/l)
Description
Percentage of time with BG > 8.5 mmol/l before and after normalization per patient and in the cohort.
Time Frame
During ICU stay, up to 15 days post-randomization.
Title
Percentage of time in the ICU (per patient and in the cohort) with hyperglycaemia (BG > 8.5 mmol/l) due to non compliance
Description
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).
Time Frame
During ICU stay, up to 15 days post-randomization.
Title
Number of hyperglycemic episodes after normalization (> 8.5 mmol/l)
Description
Three values < 8.5 mmol/h as indicator for normalization
Time Frame
From normalization time during ICU stay, up to 15 days post-randomization.
Title
Number of hyperglycemic episodes after normalization (> 8.5 mmol/l) due to non compliance
Description
Three values < 8.5 mmol/h as indicator for normalization
Time Frame
From normalization time during ICU stay, up to 15 days post-randomization.
Title
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
Description
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.
Title
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.
Description
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.
Time Frame
During ICU stay, up to 15 days post-randomization.
Title
Number of advices given by GS2 which were accepted, accepted with modification, or rejected.
Description
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.
Title
Frequency of daily and cumulated BG measurements per patient and in the cohort
Description
Frequency of BG measurements (per patient and in the cohort)
Time Frame
During ICU stay, up to 15 days post-randomization.
Title
Frequency of daily and cumulated adjustments of insulin and nutrition pump settings (per patient and in the cohort)
Description
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.
Title
Glycaemic variability
Description
Mean and standard deviation (SD) of blood glucose measurements. Daily maximum blood glucose difference.
Time Frame
During ICU stay, up to 15 days post-randomization.
Title
Protein goal achievements (80-100% of accumulated target) with a target of 1.3 g/kg of body weight per day.
Description
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.
Time Frame
During ICU stay, up to 15 days post-randomization.
Title
Caloric goal achievements (80-100% of the accumulated target) by indirect calorimetry (IC) or predictive formula if IC not feasible.
Description
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.
Time Frame
During ICU stay, up to 15 days post-randomization.
Title
Energy debt: difference between the defined energy target (80-100%, defined by IC or predictive formula) and the energy received (nutritional and non-nutritional)
Description
Per day and at the end of the ICU stay.
Time Frame
During ICU stay, up to 15 days post-randomization.
Title
Protein debt: difference between the defined protein target (1.3 g/kg of body weight/day) and the proteins received
Description
Per day and at the end of the ICU stay.
Time Frame
During ICU stay, up to 15 days post-randomization.
Title
Prediction of BG
Description
Prediction error as a function of time elapsed since last BG measurement, per patient, per cohort.measurement (per patient and per cohort).
Time Frame
During ICU stay, up to 15 days post-randomization.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia P. Heidegger, MD
Phone
+ 41 22 37 27 440
Email
claudia.heidegger@hcuge.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Aude De Watteville, Bsc
Phone
+ 41 79 55 33 998
Email
aude.dewatteville@hcuge.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia P. Heidegger, MD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux Universitaire de Genève
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Heidegger, MD
Phone
+ 41 22 37 27 440
Email
claudia.heidegger@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Aude de Watteville, Bsc
Phone
+41795533998
Email
aude.dewatteville@hcuge.ch
Facility Name
Service of Intensive Care, Geneva University Hospital,
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Heidegger, MD
Email
claudia.heidegger@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Aude De Watteville, Bsc
Email
aude.dewatteville@hcuge.ch

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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