The Glycaemic Effects of Glucerna® in Critically Ill Patients. (GluCip)

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.

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 Overview

• Status: Completed
• Conditions: Disorder of Glucose Regulation
• Intervention / Treatment: Dietary supplement: Glucerna; Dietary supplement: Fresubin

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1091 AC
      • Onze Lieve Vrouwe Gasthuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: PHJ van der Voort
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Peter HJ van der Voort, Prof. dr., Onze Lieve Vrouwe Gasthuis

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: September 16, 2015
• First Submitted That Met QC Criteria: October 30, 2015
• First Posted (Estimate): November 3, 2015

Study Record Updates

• Last Update Posted (Estimate): June 27, 2016
• Last Update Submitted That Met QC Criteria: June 24, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring; Enteral Nutrition
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: NL51918.100.14