Clinical trial NCT02337556: The DIVINE Study: DIetary Management of Glucose VarIability iN thE ICU
Official title: The DIVINE Study: DIetary Management of Glucose VarIability iN thE ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critically Ill Mechanically Ventilated Subjects
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2015-01-13
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To compare the nutritional effect on blood glucose of two commercially available enteral diets in overweight or obese patients in the Intensive Care Unit.


Eligibility criteria: Inclusion Criteria:

* New admit to the ICU and expected to remain in ICU 5 days
* Ventilator dependent up to 48 hours prior to admission to the study
* Requiring tube feeding enteral nutrition (EN) 5 days
* Expected to receive 50% of caloric needs within 72 hours
* Body Mass Index 26-45

Exclusion Criteria:

* Trauma patients
* Major surgery in past 30 days or planned for next 7 days
* Diabetes mellitus (DM) type 1
* Admitted with diagnosis of diabetic ketoacidosis as primary diagnosis
* Pregnant or lactating
* Non-functioning GI tract
* Use of parenteral nutrition in past 30 days
* Admitted with burns \> 20% body surface area
* Traumatic brain injury
* Hemodynamic instability that prevents delivery of EN \> 24hr
* Unable to access GI tract for feeding via tube, unable to receive EN
* Other contraindication to tube feeding
* Any other condition that would not allow patient to complete the study protocol
* Use of enteral formula at enrollment that cannot be changed to the investigational product

Primary outcomes:
measure: Glucose variability - Number of glycemic events outside the serum glucose range of 110-150 mg/dl
timeFrame: First seven days in the ICU
Secondary outcomes:
measure: Glucose variability - Number of glycemic events between 80-110 mg/dl and 150-180 mg/dl
timeFrame: First seven days in the ICU
measure: Glucose variability - Number of episodes of hypoglycemia (glucose < 80 mg/dl)
timeFrame: First seven days in the ICU
measure: Glucose variability - Number of episodes of hyperglycemia (glucose > 180 mg/dl)
timeFrame: First seven days in the ICU
measure: Glucose variability - Average glucose levels
timeFrame: First seven days in the ICU
measure: Need for exogenous insulin administration
timeFrame: First seven days in the ICU
measure: Need for exogenous glucose administration
timeFrame: First seven days in the ICU
measure: Nursing time
timeFrame: First seven days in the ICU
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky Albert B. Chandler Hospital
state: Kentucky
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
References: