An interventional study of Glucerna and Fresubin in Disorder of Glucose Regulation, sponsored by PHJ van der Voort. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-27.
Sponsored by PHJ van der Voort · Not applicable, Interventional, and Treatment
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.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 100 is above the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →This is the only study on the registry with PHJ van der Voort as lead sponsor.
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Exclusion Criteria:
Glucerna ® 1.5 kcal (Abbott, USA), the standard enteral formula used at our ICU and the investigational enteral feeding.
Dietary Supplement: Glucerna
Fresubin ® Energy Fibre (Fresenius, UK), the control enteral feeding.
Dietary Supplement: Fresubin
Glucerna ® 1.5 kcal (Abbott, USA), the standard enteral formula used at our ICU and the investigational enteral feeding.
Fresubin ® Energy Fibre (Fresenius, UK), the control enteral feeding.
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.
Time frame: 72 hours
Amount of insulin use
In units/day.
Time frame: 72 hours
Time in target range
Defined as a glucose between 6-9 mmol/l in minutes/day.
Time frame: 72 hours
Mean glucose and standarddeviation
Defined as the mean sensor glucose and standarddeviation in mmol/l.
Time frame: 72 hours
Number of severe hypoglycemic events
Hypoglycemic event is defined as a sensor glucose below 2.2 mmol/l.
Time frame: 72 hours
Duration of severe hypoglycemic events
Hypoglycemic event is defined as a sensor glucose below 2.2 mmol/l. Duration is measured in minutes/day.
Time frame: 72 hours
Number of severe hyperglycemic events
Hyperglycemic event is defined as a sensor glucose above 15.0 mmol/l.
Time frame: 72 hours
Duration of severe hyperglycemic events
Hyperglycemic event is defined as a sensor glucose above 15.0 mmol/l. Duration is measured in minutes/day.
Time frame: 72 hours
Daily calorie administration
Defined as amount of calories received per patient/day.
Time frame: 72 hours
Daily nutrient administration
Defined as amount of nutrients (carbohydrates, fat, proteins) received per patient/day.
Time frame: 72 hours
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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