The Glycaemic Effects of Glucerna® in Critically Ill Patients.

Disorder of Glucose Regulation Clinical Trial

— GluCip  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02594865
• Other study ID #: NL51918.100.14
• Status: Completed
• Phase: N/A
• First received: September 16, 2015
• Last updated: June 24, 2016
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Onze Lieve Vrouwe Gasthuis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Disorder of Glucose Regulation

Intervention

Dietary Supplement:
• Glucerna
Glucerna ® 1.5 kcal (Abbott, USA), the standard enteral formula used at our ICU and the investigational enteral feeding.
• Fresubin
Fresubin ® Energy Fibre (Fresenius, UK), the control enteral feeding.

Locations

Country	Name	City	State
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam	Noord-Holland

Sponsors (2)

Lead Sponsor	Collaborator
PHJ van der Voort	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Amount of insulin use	In units/day.	72 hours	No
Secondary	Time in target range	Defined as a glucose between 6-9 mmol/l in minutes/day.	72 hours	No
Secondary	Mean glucose and standarddeviation	Defined as the mean sensor glucose and standarddeviation in mmol/l.	72 hours	No
Secondary	Number of severe hypoglycemic events	Hypoglycemic event is defined as a sensor glucose below 2.2 mmol/l.	72 hours	No
Secondary	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	No
Secondary	Number of severe hyperglycemic events	Hyperglycemic event is defined as a sensor glucose above 15.0 mmol/l.	72 hours	No
Secondary	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	No
Secondary	Daily calorie administration	Defined as amount of calories received per patient/day.	72 hours	No
Secondary	Daily nutrient administration	Defined as amount of nutrients (carbohydrates, fat, proteins) received per patient/day.	72 hours	No