The DIVINE Study: DIetary Management of Glucose VarIabili... | NCT02337556

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

NCT02337556

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Jan 26, 2018Actual

Enrollment

106Actual

Phase

Not Applicable

Conditions

Critically Ill Mechanically Ventilated Subjects

Interventions

Peptamen Bariatric
Replete

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014Actual

Primary Completion Date

Oct 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Jan 9, 2015

First Submission Date that Met QC Criteria

Jan 12, 2015

First Posted Date

Jan 13, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2018

Last Update Posted Date

Jan 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

106Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention Group	Experimental	Peptamen Bariatric	Other: Peptamen Bariatric
Control Group	Active Comparator	Replete	Other: Replete

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peptamen Bariatric	Other	Commercially available enteral diet	Intervention Group

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emory University Hospital		Atlanta	Georgia	30322	United States
University of Chicago Medicine