The Glycaemic Effects of Glucerna® in Critically Ill Patients.

Study Overview
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Brief Summary
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To investigate whether the administration of Glucerna achieves less glycaemic variability, defined as the mean absolute glucose (MAG) change, and better glycaemic control compared to a standard high-carbohydrate enteral formula. Continuous glucose monitoring technology will be used to evaluate glycaemic variability and glycaemic control.

Official Title
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Glucerna in Critically Ill Patients (GluCip Trial): Investigating the Glycaemic Effects of a Reduced-carbohydrate, Modified-fat, Fiber-containing Enteral Formula (Glucerna®) in Critically Ill Patients.

Conditions
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Disorder of Glucose Regulation

Intervention / Treatment
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* Dietary Supplement: Glucerna
* Dietary Supplement: Fresubin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years; Patients with an anticipated stay of at least 48 hours of admission to the intensive care Expected to receive enteral feeding for at least 48 hrs Indication for glucose regulation with insulin (according to the current glucose treatment protocol) Patient or surrogate understands and signs informed consent document. Exclusion Criteria: Patients with pre-existing contraindications to enteral feeding or to placement of a continuous glucose monitoring system Patients previously randomised into the GluCip trial Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glucerna<br>Glucerna ® 1.5 kcal (Abbott, USA), the standard enteral formula used at our ICU and the investigational enteral feeding. | Dietary Supplement: Glucerna<br>* Glucerna ® 1.5 kcal (Abbott, USA), the standard enteral formula used at our ICU and the investigational enteral feeding.<br>|
| Active Comparator: Fresubin<br>Fresubin ® Energy Fibre (Fresenius, UK), the control enteral feeding. | Dietary Supplement: Fresubin<br>* Fresubin ® Energy Fibre (Fresenius, UK), the control enteral feeding.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose variability | The primary outcome is the extent of glucose variability, defined as the mean absolute glucose (MAG) change (delta glucose/delta time) in mmol/l/hr. | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of insulin use | In units/day. | 72 hours | 
| Time in target range | Defined as a glucose between 6-9 mmol/l in minutes/day. | 72 hours | 
| Mean glucose and standarddeviation | Defined as the mean sensor glucose and standarddeviation in mmol/l. | 72 hours | 
| Number of severe hypoglycemic events | Hypoglycemic event is defined as a sensor glucose below 2.2 mmol/l. | 72 hours | 
| Duration of severe hypoglycemic events | Hypoglycemic event is defined as a sensor glucose below 2.2 mmol/l. Duration is measured in minutes/day. | 72 hours | 
| Number of severe hyperglycemic events | Hyperglycemic event is defined as a sensor glucose above 15.0 mmol/l. | 72 hours | 
| Duration of severe hyperglycemic events | Hyperglycemic event is defined as a sensor glucose above 15.0 mmol/l. Duration is measured in minutes/day. | 72 hours | 
| Daily calorie administration | Defined as amount of calories received per patient/day. | 72 hours | 
| Daily nutrient administration | Defined as amount of nutrients (carbohydrates, fat, proteins) received per patient/day. | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enteral Nutrition, Continuous Glucose Monitoring