To determine the effects of a diabetes specific enteral formula compared to a standard formula supplemented with protein (isocaloric and isonitrogenous) on the mean blood glucose and glycemic variability in a homogenous group of critically ill patients in a neurological ICU. Blood glucose will be recorded every minute using a continuous blood glucose monitor. The primary end points will be the difference between the mean blood glucose levels and the glucose variability between the control and intervention groups for the time period that the patient is in the ICU and receiving tube feeds and for up to a maximum of 14 days.
To determine the effects of the diabetes specific versus standard tube feeds on the change in muscle thickness and volume measured by 2-dimensional ultrasound imaging during the patients ICU stay.
Trial Stopped: Unlikely to show statistical significance and slow recruitment.
- Glycerna Dietary Supplement
Intervention Desc: Diabetes specific formula ARM 1: Kind: Experimental Label: Glycerna Description: Diabetic specific formula
- Jevity - Control Diet Dietary Supplement
Intervention Desc: Control Diet ARM 1: Kind: Experimental Label: Control - Jevity Description: The control arm of the study. Patients to receive Jevity
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator)
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Glycemic variability||Entire ICU stay. Up to 14 days in the ICU (average about 7 days)||No|
|Secondary||Quadriceps muscle volume||First versus last measurment in ICU. Up to 14 days (average 7 days)||No|