Clinical trial NCT03890432: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2019-03-26
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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* Lack of legal consent or consent withdrawn, except for patients in the historical control group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

Primary outcomes:
measure: Time-in-target (range: 5.0 - 8.5 mmol/l)
timeFrame: During ICU stay, up to 15 days post-randomization.
Secondary outcomes:
measure: Overall number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events
timeFrame: During ICU stay, up to 15 days post-randomization.
measure: Overall percentage of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events
timeFrame: During ICU stay, up to 15 days post-randomization.
measure: Number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events due to non-compliance
timeFrame: During ICU stay, up to 15 days post-randomization.
measure: Percentage of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events due to non-compliance
timeFrame: During ICU stay, up to 15 days post-randomization.
measure: Time to normalize blood glucose (5.0-8.5 mmol/l)
timeFrame: During ICU stay, up to 15 days post-randomization.
measure: Percentage of time in the ICU (per patient and in the cohort) with hyperglycaemia (BG > 8.5 mmol/l)
timeFrame: During ICU stay, up to 15 days post-randomization.
measure: Percentage of time in the ICU (per patient and in the cohort) with hyperglycaemia (BG > 8.5 mmol/l) due to non compliance
timeFrame: During ICU stay, up to 15 days post-randomization.
measure: Number of hyperglycemic episodes after normalization (> 8.5 mmol/l)
timeFrame: From normalization time during ICU stay, up to 15 days post-randomization.
measure: Number of hyperglycemic episodes after normalization (> 8.5 mmol/l) due to non compliance
timeFrame: From normalization time during ICU stay, up to 15 days post-randomization.
measure: 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
timeFrame: During ICU stay, up to 15 days post-randomization.
measure: 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.
timeFrame: During ICU stay, up to 15 days post-randomization.
measure: Number of advices given by GS2 which were accepted, accepted with modification, or rejected.
timeFrame: During ICU stay, up to 15 days post-randomization.
measure: Frequency of daily and cumulated BG measurements per patient and in the cohort
timeFrame: During ICU stay, up to 15 days post-randomization.
measure: Frequency of daily and cumulated adjustments of insulin and nutrition pump settings (per patient and in the cohort)
timeFrame: During ICU stay, up to 15 days post-randomization.
measure: Glycaemic variability
timeFrame: During ICU stay, up to 15 days post-randomization.
measure: Protein goal achievements (80-100% of accumulated target) with a target of 1.3 g/kg of body weight per day.
timeFrame: During ICU stay, up to 15 days post-randomization.
measure: Caloric goal achievements (80-100% of the accumulated target) by indirect calorimetry (IC) or predictive formula if IC not feasible.
timeFrame: During ICU stay, up to 15 days post-randomization.
measure: Energy debt: difference between the defined energy target (80-100%, defined by IC or predictive formula) and the energy received (nutritional and non-nutritional)
timeFrame: During ICU stay, up to 15 days post-randomization.
measure: Protein debt: difference between the defined protein target (1.3 g/kg of body weight/day) and the proteins received
timeFrame: During ICU stay, up to 15 days post-randomization.
measure: Prediction of BG
timeFrame: During ICU stay, up to 15 days post-randomization.
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaire de Genève
city: Geneva
country: Switzerland
facility: Service of Intensive Care, Geneva University Hospital,
Study officials:
affiliation: University Hospital, Geneva
name: Claudia P. Heidegger, MD
role: PRINCIPAL_INVESTIGATOR
References: