The Glycaemic Effects of Glucerna® in Critically Ill Patients.

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02594865

Acronym

GluCip

Enrollment

100

Registered

2015-11-03

Start date

2015-09-30

Completion date

2016-06-30

Last updated

2016-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder of Glucose Regulation

Keywords

Enteral Nutrition, Continuous Glucose Monitoring

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.

Interventions

DIETARY_SUPPLEMENTGlucerna

Glucerna ® 1.5 kcal (Abbott, USA), the standard enteral formula used at our ICU and the investigational enteral feeding.

DIETARY_SUPPLEMENTFresubin

Fresubin ® Energy Fibre (Fresenius, UK), the control enteral feeding.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Time in target range	72 hours	Defined as a glucose between 6-9 mmol/l in minutes/day.
Mean glucose and standarddeviation	72 hours	Defined as the mean sensor glucose and standarddeviation in mmol/l.
Number of severe hypoglycemic events	72 hours	Hypoglycemic event is defined as a sensor glucose below 2.2 mmol/l.
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.
Amount of insulin use	72 hours	In units/day.
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.
Number of severe hyperglycemic events	72 hours	Hyperglycemic event is defined as a sensor glucose above 15.0 mmol/l.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026