Critically Ill Mechanically Ventilated SubjectsNCT02337556
The DIVINE Study: DIetary Management of Glucose VarIability iN thE ICU
A study testing Peptamen Bariatric and Replete in people with Critically Ill Mechanically Ventilated Subjects, run by Société des Produits Nestlé (SPN) at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill Mechanically Ventilated Subjects
- What is being tested?
- Peptamen Bariatric and Replete
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Nov 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Emory University Hospital
Atlanta, Georgia, 30322
University of Chicago Medicine
Chicago, Illinois, 60637
University of Kentucky Albert B. Chandler Hospital
Lexington, Kentucky, 40536
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Regions Hospital
Saint Paul, Minnesota, 55101
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
To compare the nutritional effect on blood glucose of two commercially available enteral diets in overweight or obese patients in the Intensive Care Unit.
- Being tested
- Peptamen Bariatric, Replete
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptamen BariatricOther
Commercially available enteral diet
RepleteOther
Commercially available enteral diet
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Peptamen Bariatric Receives: Other: Peptamen Bariatric |
| Control Group | Active comparator | Replete Receives: Other: Replete |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: First seven days in the ICU
Secondary outcomes (7)
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
Measured: 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)
Measured: 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)
Measured: First seven days in the ICU
Glucose variability - Average glucose levels
Average glucose levels
Measured: 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
Measured: First seven days in the ICU
Need for exogenous glucose administration
Number of times of administration and amount of glucose received
Measured: First seven days in the ICU
Nursing time
Time required to monitor glucose levels and adjust insulin regimens in subset of patients studied
Measured: First seven days in the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill Mechanically Ventilated SubjectsStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337556
- Sponsor's protocol ID
- 13.23.CLI
- Status last verified
- Jan 2018
- First submitted
- 9 Jan 2015
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DIVINE Study: DIetary Management of Glucose VarIability iN thE ICU
- ClinicalTrials.gov ID
- NCT02337556
- Acronym / sponsor ID
- 13.23.CLI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Nov 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the nutritional effect on blood glucose of two commercially available enteral diets in overweight or obese patients in the Intensive Care Unit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Peptamen BariatricPeptamen Bariatric |
| Control Group | Active comparator | Other: RepleteReplete |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peptamen BariatricCommercially available enteral diet | Other | Intervention Group |
| RepleteCommercially available enteral diet | Other | Control Group |
Primary outcome
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
7 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peptamen Bariatric and Replete in people with Critically Ill Mechanically Ventilated Subjects, run by Société des Produits Nestlé (SPN) at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose variability - Number of glycemic events outside the serum glucose range of 110-150 mg/dl (time frame: First seven days in the ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2018.