Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-04 @ 1:57 AM
Study NCT ID:
NCT02337556
Status:
COMPLETED
Last Update Posted:
2018-01-26
First Post:
2015-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The DIVINE Study: DIetary Management of Glucose VarIability iN thE ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-25', 'studyFirstSubmitDate': '2015-01-09', 'studyFirstSubmitQcDate': '2015-01-12', 'lastUpdatePostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose variability - Number of glycemic events outside the serum glucose range of 110-150 mg/dl', 'timeFrame': 'First seven days in the ICU', 'description': 'Number of glycemic events outside the serum glucose range of 110-150 mg/dl'}], 'secondaryOutcomes': [{'measure': 'Glucose variability - Number of glycemic events between 80-110 mg/dl and 150-180 mg/dl', 'timeFrame': 'First seven days in the ICU', 'description': 'Number of glycemic events between 80-110 mg/dl and 150-180 mg/dl'}, {'measure': 'Glucose variability - Number of episodes of hypoglycemia (glucose < 80 mg/dl)', 'timeFrame': 'First seven days in the ICU', 'description': 'Number of episodes of hypoglycemia (glucose \\< 80 mg/dl)'}, {'measure': 'Glucose variability - Number of episodes of hyperglycemia (glucose > 180 mg/dl)', 'timeFrame': 'First seven days in the ICU', 'description': 'Number of episodes of hyperglycemia (glucose \\> 180 mg/dl)'}, {'measure': 'Glucose variability - Average glucose levels', 'timeFrame': 'First seven days in the ICU', 'description': 'Average glucose levels'}, {'measure': 'Need for exogenous insulin administration', 'timeFrame': 'First seven days in the ICU', 'description': 'Number of administrations, amount of insulin received, number of times insulin order adjusted, circulating C-peptide at baseline, day 3, 5 and 7'}, {'measure': 'Need for exogenous glucose administration', 'timeFrame': 'First seven days in the ICU', 'description': 'Number of times of administration and amount of glucose received'}, {'measure': 'Nursing time', 'timeFrame': 'First seven days in the ICU', 'description': 'Time required to monitor glucose levels and adjust insulin regimens in subset of patients studied'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Critically Ill Mechanically Ventilated Subjects']}, 'descriptionModule': {'briefSummary': 'To compare the nutritional effect on blood glucose of two commercially available enteral diets in overweight or obese patients in the Intensive Care Unit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New admit to the ICU and expected to remain in ICU 5 days\n* Ventilator dependent up to 48 hours prior to admission to the study\n* Requiring tube feeding enteral nutrition (EN) 5 days\n* Expected to receive 50% of caloric needs within 72 hours\n* Body Mass Index 26-45\n\nExclusion Criteria:\n\n* Trauma patients\n* Major surgery in past 30 days or planned for next 7 days\n* Diabetes mellitus (DM) type 1\n* Admitted with diagnosis of diabetic ketoacidosis as primary diagnosis\n* Pregnant or lactating\n* Non-functioning GI tract\n* Use of parenteral nutrition in past 30 days\n* Admitted with burns \\> 20% body surface area\n* Traumatic brain injury\n* Hemodynamic instability that prevents delivery of EN \\> 24hr\n* Unable to access GI tract for feeding via tube, unable to receive EN\n* Other contraindication to tube feeding\n* Any other condition that would not allow patient to complete the study protocol\n* Use of enteral formula at enrollment that cannot be changed to the investigational product'}, 'identificationModule': {'nctId': 'NCT02337556', 'briefTitle': 'The DIVINE Study: DIetary Management of Glucose VarIability iN thE ICU', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'The DIVINE Study: DIetary Management of Glucose VarIability iN thE ICU', 'orgStudyIdInfo': {'id': '13.23.CLI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Peptamen Bariatric', 'interventionNames': ['Other: Peptamen Bariatric']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Replete', 'interventionNames': ['Other: Replete']}], 'interventions': [{'name': 'Peptamen Bariatric', 'type': 'OTHER', 'description': 'Commercially available enteral diet', 'armGroupLabels': ['Intervention Group']}, {'name': 'Replete', 'type': 'OTHER', 'description': 'Commercially available enteral diet', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky Albert B. Chandler Hospital', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '55101', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Regions Hospital', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': 'K7L 2V7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': "Queen's University", 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}