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

PHJ van der Voort

Status: Completed

Conditions: Disorder of Glucose Regulation

Treatments: Dietary Supplement: Glucerna; Dietary Supplement: Fresubin

Study type: Interventional

Funder types: Other

Identifiers

NCT02594865

NL51918.100.14

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Glucerna

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Glucerna

Fresubin

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Fresubin