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.
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 16, 2015
CompletedFirst Posted
Study publicly available on registry
November 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJune 27, 2016
June 1, 2016
9 months
September 16, 2015
June 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Amount of insulin use
72 hours
Time in target range
72 hours
Mean glucose and standarddeviation
72 hours
Number of severe hypoglycemic events
72 hours
Duration of severe hypoglycemic events
72 hours
- +4 more secondary outcomes
Study Arms (2)
Glucerna
ACTIVE COMPARATORGlucerna ® 1.5 kcal (Abbott, USA), the standard enteral formula used at our ICU and the investigational enteral feeding.
Fresubin
ACTIVE COMPARATORFresubin ® Energy Fibre (Fresenius, UK), the control enteral feeding.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, 1091 AC, Netherlands
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Peter HJ van der Voort, Prof. dr.
Onze Lieve Vrouwe Gasthuis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof., MD, PhD, MSc
Study Record Dates
First Submitted
September 16, 2015
First Posted
November 3, 2015
Study Start
September 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
June 27, 2016
Record last verified: 2016-06