The DIVINE Study: DIetary Management of Glucose VarIability iN thE ICU

Completed · Not applicable

Conditions studied: Critically Ill Mechanically Ventilated Subjects

In brief

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

Key facts

Study ID

NCT02337556

Run by

Société des Produits Nestlé (SPN)

People needed

106

Starts

2014-11-01

Expected to finish

2016-12-01

Last updated by the study team

2018-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Emory University Hospital — Atlanta, Georgia, United States
• University of Chicago Medicine — Chicago, Illinois, United States
• University of Kentucky Albert B. Chandler Hospital — Lexington, Kentucky, United States
• Regions Hospital — Saint Paul, Minnesota, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Queen's University — Kingston, Ontario, Canada

Full record on ClinicalTrials.gov

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