- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03890432
GLUCOSAFE 2 - A New Tool for Nutritional Management and Insulin-therapy in the Intensive Care Unit (ICU)
March 23, 2023 updated by: HEIDEGGER CP
GLUCOSAFE 2 - A New Tool for Nutritional Management and Insulin-therapy in the Intensive Care Unit (ICU): Randomized Controlled Study
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
213
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Geneva, Switzerland, 1205
- Recruiting
- Hôpitaux Universitaire de Genève
-
Contact:
- Claudia Heidegger, MD
- Phone Number: + 41 22 37 27 440
- Email: claudia.heidegger@hcuge.ch
-
Contact:
- Aude de Watteville, Bsc
- Phone Number: +41795533998
- Email: aude.dewatteville@hcuge.ch
-
Geneva, Switzerland, 1211
- Recruiting
- Service of Intensive Care, Geneva University Hospital,
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GLUCOSAFE 2
Insulin-therapy and nutrition support guided by the GLUCOSAFE 2 software.
|
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.
|
Use of the local protocols (electronic or paper version) for nutrition management and blood glucose control.
|
Other: 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.
|
Use of the local protocols (electronic or paper version) for nutrition management and blood glucose control.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
During ICU stay, up to 15 days post-randomization.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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
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)
|
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
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)
|
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
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)
|
During ICU stay, up to 15 days post-randomization.
|
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
|
During ICU stay, up to 15 days post-randomization.
|
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.
|
During ICU stay, up to 15 days post-randomization.
|
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).
|
During ICU stay, up to 15 days post-randomization.
|
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
|
From normalization time during ICU stay, up to 15 days post-randomization.
|
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
|
From normalization time 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
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
|
During ICU stay, up to 15 days post-randomization.
|
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.
|
During ICU stay, up to 15 days post-randomization.
|
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.
|
During ICU stay, up to 15 days post-randomization.
|
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)
|
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)
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)
|
During ICU stay, up to 15 days post-randomization.
|
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.
|
During ICU stay, up to 15 days post-randomization.
|
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.
|
During ICU stay, up to 15 days post-randomization.
|
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.
|
During ICU stay, up to 15 days post-randomization.
|
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.
|
During ICU stay, up to 15 days post-randomization.
|
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.
|
During ICU stay, up to 15 days post-randomization.
|
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).
|
During ICU stay, up to 15 days post-randomization.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2023
Primary Completion (Anticipated)
September 1, 2023
Study Completion (Anticipated)
November 1, 2023
Study Registration Dates
First Submitted
February 14, 2019
First Submitted That Met QC Criteria
March 22, 2019
First Posted (Actual)
March 26, 2019
Study Record Updates
Last Update Posted (Actual)
March 27, 2023
Last Update Submitted That Met QC Criteria
March 23, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- G2-0219
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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