The Glycaemic Effects of Glucerna® in Critically Ill Patients.

Not Applicable

Completed

• Conditions: Disorder of Glucose Regulation
• Interventions: Dietary Supplement: Glucerna; Dietary Supplement: Fresubin

• Registration Number: NCT02594865
• Lead Sponsor: PHJ van der Voort

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-16
• Study First Submitted QC: 2015-10-30
• Study First Posted: 2015-11-03
• Status Verified: 2016-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-24
• Last Update Posted: 2016-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glucerna	Glucerna	Glucerna ® 1.5 kcal (Abbott, USA), the standard enteral formula used at our ICU and the investigational enteral feeding.
Fresubin	Fresubin	Fresubin ® Energy Fibre (Fresenius, UK), the control enteral feeding.

Primary Outcome Measures

Name	Time	Method
Glucose variability	72 hours	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Noord-Holland, Netherlands