---
title: "The DIVINE Study: DIetary Management of Glucose VarIability iN thE ICU"
nct_id: NCT02337556
overall_status: COMPLETED
phase: NA
sponsor: Société des Produits Nestlé (SPN)
study_type: INTERVENTIONAL
primary_condition: Critically Ill Mechanically Ventilated Subjects
countries: United States, Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02337556.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02337556"
ct_last_update_post_date: 2018-01-26
last_seen_at: "2026-05-12T07:08:43.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The DIVINE Study: DIetary Management of Glucose VarIability iN thE ICU

**NCT ID:** [NCT02337556](https://clinicaltrials.gov/study/NCT02337556)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 106
- **Lead Sponsor:** Société des Produits Nestlé (SPN)
- **Conditions:** Critically Ill Mechanically Ventilated Subjects
- **Start Date:** 2014-11
- **Completion Date:** 2016-12
- **CT.gov Last Update:** 2018-01-26

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Intervention Group** (EXPERIMENTAL) — Peptamen Bariatric
- **Control Group** (ACTIVE_COMPARATOR) — Replete

## Interventions

- **Peptamen Bariatric** (OTHER) — Commercially available enteral diet
- **Replete** (OTHER) — Commercially available enteral diet

## Primary Outcomes

- **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

- **Glucose variability - Number of glycemic events between 80-110 mg/dl and 150-180 mg/dl** _(time frame: First seven days in the ICU)_
- **Glucose variability - Number of episodes of hypoglycemia (glucose < 80 mg/dl)** _(time frame: First seven days in the ICU)_
- **Glucose variability - Number of episodes of hyperglycemia (glucose > 180 mg/dl)** _(time frame: First seven days in the ICU)_
- **Glucose variability - Average glucose levels** _(time frame: First seven days in the ICU)_
- **Need for exogenous insulin administration** _(time frame: First seven days in the ICU)_
- **Need for exogenous glucose administration** _(time frame: First seven days in the ICU)_
- **Nursing time** _(time frame: First seven days in the ICU)_

## Locations (7)

- Emory University Hospital, Atlanta, Georgia, United States
- University of Chicago Medicine, Chicago, Illinois, United States
- University of Kentucky Albert B. Chandler Hospital, Lexington, Kentucky, United States
- Regions Hospital, Saint Paul, Minnesota, 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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.emory university hospital|atlanta|georgia|united states` — added _(2026-05-12)_
- `locations.university of chicago medicine|chicago|illinois|united states` — added _(2026-05-12)_
- `locations.university of kentucky albert b. chandler hospital|lexington|kentucky|united states` — added _(2026-05-12)_
- `locations.regions hospital|saint paul|minnesota|united states` — added _(2026-05-12)_
- `locations.wake forest university health sciences|winston-salem|north carolina|united states` — added _(2026-05-12)_
- `locations.vanderbilt university medical center|nashville|tennessee|united states` — added _(2026-05-12)_
- `locations.queen's university|kingston|ontario|canada` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT02337556*  
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