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

Not Applicable

Completed

• Conditions: Critically Ill Mechanically Ventilated Subjects
• Interventions: Other: Replete; Other: Peptamen Bariatric

• Registration Number: NCT02337556
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-01-12
• Study First Posted: 2015-01-13
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-25
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Replete	Replete
Intervention Group	Peptamen Bariatric	Peptamen Bariatric

Primary Outcome Measures

Name	Time	Method
Glucose variability - Number of glycemic events outside the serum glucose range of 110-150 mg/dl	First seven days in the ICU	Number of glycemic events outside the serum glucose range of 110-150 mg/dl

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Regions Hospital; 🇺🇸 Saint Paul, Minnesota, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

University of Kentucky Albert B. Chandler Hospital; 🇺🇸 Lexington, Kentucky, United States

University of Chicago Medicine; 🇺🇸 Chicago, Illinois, 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