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Completed

NCT Number: NCT02337556

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.

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Key information

Conditions

Critically Ill Mechanically Ventilated Subjects

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen's University, Kingston, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peptamen Bariatric

Other

Commercially available enteral diet

Replete

Other

Commercially available enteral diet

Primary outcomes

  1. Glucose variability - Number of glycemic events outside the serum glucose range of 110-150 mg/dl

    Time frame: First seven days in the ICU

    Number of glycemic events outside the serum glucose range of 110-150 mg/dl

Secondary outcomes

  1. Glucose variability - Number of glycemic events between 80-110 mg/dl and 150-180 mg/dl

    Time frame: First seven days in the ICU

    Number of glycemic events between 80-110 mg/dl and 150-180 mg/dl

  2. Glucose variability - Number of episodes of hypoglycemia (glucose < 80 mg/dl)

    Time frame: First seven days in the ICU

    Number of episodes of hypoglycemia (glucose < 80 mg/dl)

  3. Glucose variability - Number of episodes of hyperglycemia (glucose > 180 mg/dl)

    Time frame: First seven days in the ICU

    Number of episodes of hyperglycemia (glucose > 180 mg/dl)

  4. Glucose variability - Average glucose levels

    Time frame: First seven days in the ICU

    Average glucose levels

  5. Need for exogenous insulin administration

    Time frame: 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

  6. Need for exogenous glucose administration

    Time frame: First seven days in the ICU

    Number of times of administration and amount of glucose received

  7. Nursing time

    Time frame: First seven days in the ICU

    Time required to monitor glucose levels and adjust insulin regimens in subset of patients studied

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 13, 2015
Registry last updated
Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.