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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03890432
• Other study ID #: G2-0219
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: November 2023

Study information

• Verified date: March 2023
• Source: University Hospital, Geneva
• Contact: Claudia P. Heidegger, MD
• Phone: + 41 22 37 27 440
• Email: claudia.heidegger[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 213
• Est. completion date: November 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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• Lack of legal consent or consent withdrawn, except for patients in the historical control group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

Related Conditions & MeSH terms

• Critical Illness
• Energy Supply; Deficiency, Severe
• Hyperglycemia
• Hypoglycemia
• Protein Deficiency

Intervention

Device:
• GLUCOSAFE 2
Use of GLUCOSAFE 2 software for nutrition management and insulin-therapy
• 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 with routine care
Use of the local protocols (electronic or paper version) for nutrition management and blood glucose control.

Locations

Country	Name	City	State
Switzerland	Hôpitaux Universitaire de Genève	Geneva
Switzerland	Service of Intensive Care, Geneva University Hospital,	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
HEIDEGGER CP	Aalborg University

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	During ICU stay, up to 15 days post-randomization.
Secondary	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)	During ICU stay, up to 15 days post-randomization.
Secondary	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)	During ICU stay, up to 15 days post-randomization.
Secondary	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)	During ICU stay, up to 15 days post-randomization.
Secondary	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)	During ICU stay, up to 15 days post-randomization.
Secondary	Time to normalize blood glucose (5.0-8.5 mmol/l)	Three values < 8.5 mmol/l as indicator for normalization	During ICU stay, up to 15 days post-randomization.
Secondary	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.	During ICU stay, up to 15 days post-randomization.
Secondary	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).	During ICU stay, up to 15 days post-randomization.
Secondary	Number of hyperglycemic episodes after normalization (> 8.5 mmol/l)	Three values < 8.5 mmol/h as indicator for normalization	From normalization time during ICU stay, up to 15 days post-randomization.
Secondary	Number of hyperglycemic episodes after normalization (> 8.5 mmol/l) due to non compliance	Three values < 8.5 mmol/h as indicator for normalization	From normalization time during ICU stay, up to 15 days post-randomization.
Secondary	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	During ICU stay, up to 15 days post-randomization.
Secondary	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.	During ICU stay, up to 15 days post-randomization.
Secondary	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.	During ICU stay, up to 15 days post-randomization.
Secondary	Frequency of daily and cumulated BG measurements per patient and in the cohort	Frequency of BG measurements (per patient and in the cohort)	During ICU stay, up to 15 days post-randomization.
Secondary	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)	During ICU stay, up to 15 days post-randomization.
Secondary	Glycaemic variability	Mean and standard deviation (SD) of blood glucose measurements. Daily maximum blood glucose difference.	During ICU stay, up to 15 days post-randomization.
Secondary	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.	During ICU stay, up to 15 days post-randomization.
Secondary	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.	During ICU stay, up to 15 days post-randomization.
Secondary	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.	During ICU stay, up to 15 days post-randomization.
Secondary	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.	During ICU stay, up to 15 days post-randomization.
Secondary	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).	During ICU stay, up to 15 days post-randomization.