Back to resultsThe Glycaemic Effects of Glucerna® in Critically Ill Patients. (GluCip)
Primary Purpose
Disorder of Glucose Regulation
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Glucerna
Fresubin
Sponsored by
About this trial
This is an interventional treatment trial for Disorder of Glucose Regulation focused on measuring Enteral Nutrition, Continuous Glucose Monitoring
Eligibility Criteria
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.
Sites / Locations
- Onze Lieve Vrouwe Gasthuis
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Glucerna
Fresubin
Arm Description
Glucerna ® 1.5 kcal (Abbott, USA), the standard enteral formula used at our ICU and the investigational enteral feeding.
Fresubin ® Energy Fibre (Fresenius, UK), the control enteral feeding.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Amount of insulin use
In units/day.
Time in target range
Defined as a glucose between 6-9 mmol/l in minutes/day.
Mean glucose and standarddeviation
Defined as the mean sensor glucose and standarddeviation in mmol/l.
Number of severe hypoglycemic events
Hypoglycemic event is defined as a sensor glucose below 2.2 mmol/l.
Duration of severe hypoglycemic events
Hypoglycemic event is defined as a sensor glucose below 2.2 mmol/l. Duration is measured in minutes/day.
Number of severe hyperglycemic events
Hyperglycemic event is defined as a sensor glucose above 15.0 mmol/l.
Duration of severe hyperglycemic events
Hyperglycemic event is defined as a sensor glucose above 15.0 mmol/l. Duration is measured in minutes/day.
Daily calorie administration
Defined as amount of calories received per patient/day.
Daily nutrient administration
Defined as amount of nutrients (carbohydrates, fat, proteins) received per patient/day.
Full Information
NCT ID
NCT02594865
First Posted
September 16, 2015
Last Updated
June 24, 2016
Sponsor
PHJ van der Voort
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1. Study Identification
Unique Protocol Identification Number
NCT02594865
Brief Title
The Glycaemic Effects of Glucerna® in Critically Ill Patients.
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
PHJ van der Voort
Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Glucose Regulation
Keywords
Enteral Nutrition, Continuous Glucose Monitoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glucerna
Arm Type
Active Comparator
Arm Description
Glucerna ® 1.5 kcal (Abbott, USA), the standard enteral formula used at our ICU and the investigational enteral feeding.
Arm Title
Fresubin
Arm Type
Active Comparator
Arm Description
Fresubin ® Energy Fibre (Fresenius, UK), the control enteral feeding.
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucerna
Intervention Description
Glucerna ® 1.5 kcal (Abbott, USA), the standard enteral formula used at our ICU and the investigational enteral feeding.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fresubin
Intervention Description
Fresubin ® Energy Fibre (Fresenius, UK), the control enteral feeding.
Primary Outcome Measure Information:
Title
Glucose variability
Description
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 Outcome Measure Information:
Title
Amount of insulin use
Description
In units/day.
Time Frame
72 hours
Title
Time in target range
Description
Defined as a glucose between 6-9 mmol/l in minutes/day.
Time Frame
72 hours
Title
Mean glucose and standarddeviation
Description
Defined as the mean sensor glucose and standarddeviation in mmol/l.
Time Frame
72 hours
Title
Number of severe hypoglycemic events
Description
Hypoglycemic event is defined as a sensor glucose below 2.2 mmol/l.
Time Frame
72 hours
Title
Duration of severe hypoglycemic events
Description
Hypoglycemic event is defined as a sensor glucose below 2.2 mmol/l. Duration is measured in minutes/day.
Time Frame
72 hours
Title
Number of severe hyperglycemic events
Description
Hyperglycemic event is defined as a sensor glucose above 15.0 mmol/l.
Time Frame
72 hours
Title
Duration of severe hyperglycemic events
Description
Hyperglycemic event is defined as a sensor glucose above 15.0 mmol/l. Duration is measured in minutes/day.
Time Frame
72 hours
Title
Daily calorie administration
Description
Defined as amount of calories received per patient/day.
Time Frame
72 hours
Title
Daily nutrient administration
Description
Defined as amount of nutrients (carbohydrates, fat, proteins) received per patient/day.
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter HJ van der Voort, Prof. dr.
Organizational Affiliation
Onze Lieve Vrouwe Gasthuis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1091 AC
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
The Glycaemic Effects of Glucerna® in Critically Ill Patients.
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