The Glycaemic Effects of Glucerna® in Critically Ill Patients.

PHJ van der Voort100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Disorder of Glucose Regulation

Interventions

GlucernaDIETARY_SUPPLEMENT

Glucerna ® 1.5 kcal (Abbott, USA), the standard enteral formula used at our ICU and the investigational enteral feeding.

FresubinDIETARY_SUPPLEMENT

Fresubin ® Energy Fibre (Fresenius, UK), the control enteral feeding.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, Netherlands

Outcomes

Primary Outcomes

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.

Time frame: 72 hours

Secondary Outcomes

Amount of insulin use

In units/day.

Time frame: 72 hours

Time in target range

Defined as a glucose between 6-9 mmol/l in minutes/day.

Time frame: 72 hours

Mean glucose and standarddeviation

Defined as the mean sensor glucose and standarddeviation in mmol/l.

Time frame: 72 hours

Number of severe hypoglycemic events

Hypoglycemic event is defined as a sensor glucose below 2.2 mmol/l.

Time frame: 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.

Time frame: 72 hours

Number of severe hyperglycemic events

Hyperglycemic event is defined as a sensor glucose above 15.0 mmol/l.

Time frame: 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.

Time frame: 72 hours

Data from ClinicalTrials.gov

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