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OpenTrials
Completed

NCT Number: NCT02594865

The Glycaemic Effects of Glucerna® in Critically Ill Patients.

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.

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Key information

Conditions

Disorder of Glucose Regulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, 1091 AC, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glucerna

Dietary Supplement

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

Fresubin

Dietary Supplement

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

Primary outcomes

  1. Glucose variability

    Time frame: 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 outcomes

  1. Amount of insulin use

    Time frame: 72 hours

    In units/day.

  2. Time in target range

    Time frame: 72 hours

    Defined as a glucose between 6-9 mmol/l in minutes/day.

  3. Mean glucose and standarddeviation

    Time frame: 72 hours

    Defined as the mean sensor glucose and standarddeviation in mmol/l.

  4. Number of severe hypoglycemic events

    Time frame: 72 hours

    Hypoglycemic event is defined as a sensor glucose below 2.2 mmol/l.

  5. Duration of severe hypoglycemic events

    Time frame: 72 hours

    Hypoglycemic event is defined as a sensor glucose below 2.2 mmol/l. Duration is measured in minutes/day.

  6. Number of severe hyperglycemic events

    Time frame: 72 hours

    Hyperglycemic event is defined as a sensor glucose above 15.0 mmol/l.

  7. Duration of severe hyperglycemic events

    Time frame: 72 hours

    Hyperglycemic event is defined as a sensor glucose above 15.0 mmol/l. Duration is measured in minutes/day.

  8. Daily calorie administration

    Time frame: 72 hours

    Defined as amount of calories received per patient/day.

  9. Daily nutrient administration

    Time frame: 72 hours

    Defined as amount of nutrients (carbohydrates, fat, proteins) received per patient/day.

Sponsors and collaborators

Lead sponsor

PHJ van der Voort

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Registry information

Official study 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.

Acronym: GluCip

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 3, 2015
Registry last updated
Jun 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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