Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-26 @ 11:04 AM
Study NCT ID:
NCT00655460
Status:
UNKNOWN
Last Update Posted:
2015-02-26
First Post:
2008-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-02-24', 'studyFirstSubmitDate': '2008-04-07', 'studyFirstSubmitQcDate': '2008-04-07', 'lastUpdatePostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome variable during Phase I will be the acceptability of the eProtocol-insulin instructions (compliance of bedside clinicians with instructions: more than 90 % of all instructions accepted by the bedside clinician).', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Proportion of glucose determinations within the range of 70-110 mg/dl (3.9-6.1 mMol/l)', 'timeFrame': '3 years'}, {'measure': 'Nursing perception of workload in comparison to ordinary care', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Glucose', 'Insulin', 'computer', 'critical care'], 'conditions': ['Critically Ill', 'Hyperglycemia']}, 'descriptionModule': {'briefSummary': 'The Purpose of this study is to:\n\n1. Refine and validate a computerized bedside decision support tool blood glucose management in critically ill adult and pediatric ICU patients.\n2. Monitor how often low blood sugar levels occur during use of the bedside tool.\n3. Determine how the computerized tool effects the workload of the ICU nurses.', 'detailedDescription': 'This first phase will be a prospective cohort study. We will validate the bedside tool in at least 4 adult and at least 4 pediatric ICUs and if necessary we will modify the bedside tool. The computerized bedside tool will be considered refined if \\>90% of the generated instructions are accepted and if the percent of glucose values in the 70-110 mg/dl range are equivalent to our pilot experience rate of 55%, and if the rate of glucose values less than or equal to 40 mg/dl is less than 0.5% of glucose measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pediatric ICU: Proposed indications by pediatric clinicians at participating ICUs for glucose control in their ICUs would include patients who require mechanical ventilation for greater than 24 hours and/or require a vasoactive infusion (e.g. dopamine \\>3 mg/kg/min, dobutamine, epinephrine, or vasopressin).\n2. Adult ICUs: Proposed indications by clinicians in participating ICUs for glucose control in participating adult ICUs include critically ill patients with an anticipated ICU length of stay of 3 or more days.\n\nExclusion Criteria:\n\n1. Pregnancy (negative pregnancy test required for females of child-bearing age)\n2. Age less than one month\n3. Inborn errors of metabolism that the clinician suspects will affect glucose homeostasis\n4. Acute or chronic liver disease with any documented episode of blood or plasma glucose \\<60 mg/dl within the 24 hours prior to study entry\n5. Diabetic Ketoacidosis (critically ill patients with insulin dependent diabetes not in ketoacidosis will be eligible if attending physicians intend to use intravenous insulin as part of ordinary care)\n6. Severe chronic liver disease (Child-Pugh score \\>10)'}, 'identificationModule': {'nctId': 'NCT00655460', 'briefTitle': 'Improving Blood Glucose Control With a Computerized Decision Support Tool: Phase 1', 'organization': {'class': 'OTHER', 'fullName': 'Intermountain Health Care, Inc.'}, 'officialTitle': 'Clinical Process Improvement With A Bedside Computerized Insulin Therapy Protocol For Blood Glucose Control (eProtocol-insulin) in Adult And Pediatric ICU Patients:Further Refinement and Validation of eProtocol-insulin', 'orgStudyIdInfo': {'id': 'N01-HC-45210-1'}, 'secondaryIdInfos': [{'id': 'HHSN268200425210C'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'eProtocol', 'interventionNames': ['Procedure: glucose control with computer generated recommendations']}], 'interventions': [{'name': 'glucose control with computer generated recommendations', 'type': 'PROCEDURE', 'description': 'Insulin dosing will be recommended by the computer tools based on subject glucose values. Bedside clinicians will have the ablity to accept or reject the suggested dose.', 'armGroupLabels': ['eProtocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05520', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Roy Brower, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01199', 'city': 'Springfield', 'state': 'Massachusetts', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Baystate Medical Center', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert D Hite, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wake Forest Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '17033', 'city': 'Hersey', 'state': 'Pennsylvania', 'status': 'COMPLETED', 'country': 'United States', 'facility': "Pennsylvania State Children's Hospital"}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'COMPLETED', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '84143', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'James Orme, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'LDS Hospital', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84143', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'COMPLETED', 'country': 'United States', 'facility': "Primary Children's Hospital", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'Alan H Morris, MD', 'role': 'CONTACT', 'email': 'Alan.Morris@intermountainmail.org', 'phone': '801-408-1610'}], 'overallOfficials': [{'name': 'Alan H Morris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intermountain Medical Center, Murray, Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intermountain Health Care, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}