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.

Completed

Conditions: diabetes
glucose variability
10018424
stress-hyperglycaemia

Registration Number: NL-OMON42200

Lead Sponsor: Onze Lieve Vrouwe Gasthuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

Age >= 18 years
Patients with an anticipated stay of at least 24 hours of admission to the intensive care
Expected to receive enteral feeding for at least 72 hours
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 CGM 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome will be the extent of glucose variability, defined as the<br /><br>mean absolute glucose (MAG) change (delta glucose/delta time) in mmol/l/hr,<br /><br>measured by continuous glucose monitoring technology. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include: time in target range (between 6-9 mmol/l) and below<br /><br>and above target range, mean (sensor) glucose, standard deviation of glucose<br /><br>values, severe hypo- and hyperglycaemic events (<2.2 mmol/l and > 15.0 mmol/l),<br /><br>amount of insulin use, daily nutritional administration, clinical<br /><br>gastrointestinal symptoms. </p><br>