The Glycaemic Effects of Glucerna® in Critically Ill Patients.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Glycemic Index Variation During Low-carbohydrate Enteral Formula With and Without Fructose in Critically Ill Patients

NCT03003507

Critical Illness

COMPLETED PHASE4

Enteral Nutrition and Glucose Homeostasis

NCT03012867

Hyperglycemia Stress

COMPLETED PHASE4

Enteral Nutrition and Glycemic Variability Neurological Intensive Care Unit Study

NCT01463878

Subarachnoid Hemorrhage Intracranial Hemorrhage Ischemic Strokes +1 more

TERMINATED PHASE4

Effects of GlucoClear CGM System on the Performance of Insulin Therapy in Critically Ill Patients

NCT03047824

Metabolic Stress Hyperglycemia

COMPLETED NA

Efficiency of Continuous Glucose Monitoring in Critically Ill Patients

NCT00494078

Critical Illness

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Disorder of Glucose Regulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Glucerna

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

Group Type ACTIVE_COMPARATOR

Glucerna

Intervention Type DIETARY_SUPPLEMENT

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

Fresubin

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

Group Type ACTIVE_COMPARATOR

Fresubin

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Glucerna

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

Intervention Type DIETARY_SUPPLEMENT

Fresubin

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No