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

Primary Purpose

Critically Ill Mechanically Ventilated Subjects

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Peptamen Bariatric
Replete
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Critically Ill Mechanically Ventilated Subjects

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory University Hospital
  • University of Chicago Medicine
  • University of Kentucky Albert B. Chandler Hospital
  • Regions Hospital
  • Wake Forest University Health Sciences
  • Vanderbilt University Medical Center
  • Queen's University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

Peptamen Bariatric

Replete

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Glucose variability - Number of episodes of hypoglycemia (glucose < 80 mg/dl)
Number of episodes of hypoglycemia (glucose < 80 mg/dl)
Glucose variability - Number of episodes of hyperglycemia (glucose > 180 mg/dl)
Number of episodes of hyperglycemia (glucose > 180 mg/dl)
Glucose variability - Average glucose levels
Average glucose levels
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
Need for exogenous glucose administration
Number of times of administration and amount of glucose received
Nursing time
Time required to monitor glucose levels and adjust insulin regimens in subset of patients studied

Full Information

First Posted
January 9, 2015
Last Updated
January 25, 2018
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT02337556
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill Mechanically Ventilated Subjects

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Peptamen Bariatric
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Replete
Intervention Type
Other
Intervention Name(s)
Peptamen Bariatric
Intervention Description
Commercially available enteral diet
Intervention Type
Other
Intervention Name(s)
Replete
Intervention Description
Commercially available enteral diet
Primary Outcome Measure Information:
Title
Glucose variability - Number of glycemic events outside the serum glucose range of 110-150 mg/dl
Description
Number of glycemic events outside the serum glucose range of 110-150 mg/dl
Time Frame
First seven days in the ICU
Secondary Outcome Measure Information:
Title
Glucose variability - Number of glycemic events between 80-110 mg/dl and 150-180 mg/dl
Description
Number of glycemic events between 80-110 mg/dl and 150-180 mg/dl
Time Frame
First seven days in the ICU
Title
Glucose variability - Number of episodes of hypoglycemia (glucose < 80 mg/dl)
Description
Number of episodes of hypoglycemia (glucose < 80 mg/dl)
Time Frame
First seven days in the ICU
Title
Glucose variability - Number of episodes of hyperglycemia (glucose > 180 mg/dl)
Description
Number of episodes of hyperglycemia (glucose > 180 mg/dl)
Time Frame
First seven days in the ICU
Title
Glucose variability - Average glucose levels
Description
Average glucose levels
Time Frame
First seven days in the ICU
Title
Need for exogenous insulin administration
Description
Number of administrations, amount of insulin received, number of times insulin order adjusted, circulating C-peptide at baseline, day 3, 5 and 7
Time Frame
First seven days in the ICU
Title
Need for exogenous glucose administration
Description
Number of times of administration and amount of glucose received
Time Frame
First seven days in the ICU
Title
Nursing time
Description
Time required to monitor glucose levels and adjust insulin regimens in subset of patients studied
Time Frame
First seven days in the ICU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Kentucky Albert B. Chandler Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada

12. IPD Sharing Statement

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

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