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

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

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

Conditions
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Critically Ill Mechanically Ventilated Subjects

Intervention / Treatment
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* Other: Peptamen Bariatric
* Other: Replete


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Peptamen Bariatric | Other: Peptamen Bariatric<br>* Commercially available enteral diet<br>|
| Active Comparator: Control Group<br>Replete | Other: Replete<br>* Commercially available enteral diet<br>|

What is the study measuring?
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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 |