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

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

Study Overview

• Status: Completed
• Conditions: Critically Ill Mechanically Ventilated Subjects
• Intervention / Treatment: Other: Peptamen Bariatric; Other: Replete

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Queen's University
• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medicine
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Albert B. Chandler Hospital
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Peptamen Bariatric	Other: Peptamen Bariatric; Commercially available enteral diet
Active Comparator: Control Group; Replete	Other: Replete; Commercially available enteral diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose variability - Number of glycemic events outside the serum glucose range of 110-150 mg/dl	Number of glycemic events outside the serum glucose range of 110-150 mg/dl	First seven days in the ICU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose variability - Number of glycemic events between 80-110 mg/dl and 150-180 mg/dl	Number of glycemic events between 80-110 mg/dl and 150-180 mg/dl	First seven days in the ICU
Glucose variability - Number of episodes of hypoglycemia (glucose < 80 mg/dl)	Number of episodes of hypoglycemia (glucose < 80 mg/dl)	First seven days in the ICU
Glucose variability - Number of episodes of hyperglycemia (glucose > 180 mg/dl)	Number of episodes of hyperglycemia (glucose > 180 mg/dl)	First seven days in the ICU
Glucose variability - Average glucose levels	Average glucose levels	First seven days in the ICU
Need for exogenous insulin administration	Number of administrations, amount of insulin received, number of times insulin order adjusted, circulating C-peptide at baseline, day 3, 5 and 7	First seven days in the ICU
Need for exogenous glucose administration	Number of times of administration and amount of glucose received	First seven days in the ICU
Nursing time	Time required to monitor glucose levels and adjust insulin regimens in subset of patients studied	First seven days in the ICU

Collaborators and Investigators

• Sponsor: Nestlé

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 9, 2015
• First Submitted That Met QC Criteria: January 12, 2015
• First Posted (Estimate): January 13, 2015

Study Record Updates

• Last Update Posted (Actual): January 26, 2018
• Last Update Submitted That Met QC Criteria: January 25, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 13.23.CLI