Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2026-02-06 @ 9:14 AM
Study NCT ID:
NCT00645827
Status:
COMPLETED
Last Update Posted:
2014-09-15
First Post:
2008-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of an Insulin Infusion Conversion Equation (IICE) to Control Blood Glucose in Hospitalized Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'grsmith@emory.edu', 'phone': '404.686.6730', 'title': 'G. Randy Smith Jr.', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Insulin Infusion Conversion Equation', 'description': "Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.\n\nIICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \\[3 x scheduled aspart dose\\]). For BG \\< 70 mg/dL, ½ ampule D50W IV x1 was given.", 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': "Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.\n\nHealthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \\[3 x scheduled aspart dose\\]). For BG \\< 70 mg/dL, ½ ampule D50W IV x1 was given.", 'otherNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Blood Glucose Values Within 80-140 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Infusion Conversion Equation', 'description': "Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.\n\nIICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \\[3 x scheduled aspart dose\\]). For BG \\< 70 mg/dL, ½ ampule D50W IV x1 was given."}, {'id': 'OG001', 'title': 'Control', 'description': "Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.\n\nHealthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \\[3 x scheduled aspart dose\\]). For BG \\< 70 mg/dL, ½ ampule D50W IV x1 was given."}], 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '0.68'}, {'value': '21.2', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '0.33'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 24 hours after cessation of IV insulin', 'description': 'Fingerstick glucose measurements were obtained up to six times for each participant. Percentage of blood glucose values within the target range of 80-140 mg/dL', 'unitOfMeasure': 'percentage of blood glucose values', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hypoglycemia (Serum Blood Glucose < 70 mg/dL)', 'timeFrame': 'Within 24 hours after cessation of IV insulin', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Infusion Conversion Equation', 'description': "Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.\n\nIICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \\[3 x scheduled aspart dose\\]). For BG \\< 70 mg/dL, ½ ampule D50W IV x1 was given."}, {'id': 'FG001', 'title': 'Control', 'description': "Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.\n\nHealthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \\[3 x scheduled aspart dose\\]). For BG \\< 70 mg/dL, ½ ampule D50W IV x1 was given."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were enrolled between April 2008 to February 2009.', 'preAssignmentDetails': "78 subjects consented. 3 subjects excluded at screening. Of the 75 subjects remaining, only 57 subjects seen by the principal investigator (PI) because the patient's healthcare provider had to call the PI right before the intravenous insulin infusion (III) was discontinued. PI excluded 26 more subjects at III cessation--31 subjects randomized."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulin Infusion Conversion Equation', 'description': "Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.\n\nIICE Dosing: Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \\[3 x scheduled aspart dose\\]). For BG \\< 70 mg/dL, ½ ampule D50W IV x1 was given."}, {'id': 'BG001', 'title': 'Control', 'description': "Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.\n\nHealthcare Provider dosing: Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \\[3 x scheduled aspart dose\\]). For BG \\< 70 mg/dL, ½ ampule D50W IV x1 was given."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age > 18 years old', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Age \\> 18 years old', 'unitOfMeasure': 'participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Unknown', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Gender not collected', 'unitOfMeasure': 'participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-12', 'studyFirstSubmitDate': '2008-03-25', 'resultsFirstSubmitDate': '2014-09-03', 'studyFirstSubmitQcDate': '2008-03-27', 'lastUpdatePostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-12', 'studyFirstPostDateStruct': {'date': '2008-03-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Blood Glucose Values Within 80-140 mg/dL', 'timeFrame': 'Within 24 hours after cessation of IV insulin', 'description': 'Fingerstick glucose measurements were obtained up to six times for each participant. Percentage of blood glucose values within the target range of 80-140 mg/dL'}], 'secondaryOutcomes': [{'measure': 'Hypoglycemia (Serum Blood Glucose < 70 mg/dL)', 'timeFrame': 'Within 24 hours after cessation of IV insulin'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Insulin', 'Blood Glucose'], 'conditions': ['Glucose, Blood']}, 'descriptionModule': {'briefSummary': "Insulin infusions are commonly used in hospitalized diabetics to control blood sugar, and they are effective. However, insulin infusions require the use of limited resources. Insulin infusions are therefore changed to insulin shots as a patient recovers. Once an insulin infusion is stopped and shots are started, blood sugar control is harder to maintain. This is, in part, because physicians have different ideas on how to dose insulin shots in hospitalized patients. A math equation has been developed by the research staff that attempts to predict the effective doses of insulin shots in patients whose insulin infusion have just been stopped. The math equation was developed for patients with type 2 diabetes mellitus. In this study, all patients will be treated with the same type of insulin shots, with doses of the insulin shots chosen either by the math equation or by the judgment of the patient's physician. The study will then follow blood sugar values for 24 hours to see if the math equation is effective. If the equation is proven to be effective, a new tool will exist for physicians to determine the best dose of insulin shots for type 2 diabetics. Such a tool would, in turn, allow for widespread use of insulin infusions to determine a patient's insulin needs before discharge from the hospital. Blood sugar control for type 2 diabetics that are inpatient or outpatient would improve as a result, with potentially far reaching public health benefits."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatients at an urban, mixed academic and community tertiary care hospital who were on IV insulin were enrolled.\n* Patients were taken from medical, general surgical, and cardiothoracic services, and were located both inside and outside the intensive care unit (ICU).\n\nExclusion Criteria:\n\n* At time of enrollment, patients with type I diabetes mellitus,\n* active acute or chronic pancreatitis,\n* history of pancreatic surgery,\n* use of a self-titratable insulin pump, or\n* history of β-islet cell transplantation were excluded.\n* At time of randomization, patients with insulin drip rates ≤ 2 units/hr, ∆ in serum creatinine of \\> 20% in previous 24 hours, or\n* those without caloric intake while on IV insulin were excluded.'}, 'identificationModule': {'nctId': 'NCT00645827', 'acronym': 'IICE', 'briefTitle': 'Use of an Insulin Infusion Conversion Equation (IICE) to Control Blood Glucose in Hospitalized Patients', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Use of an Insulin Infusion Conversion Equation (IICE) to Improve Inpatient Glycemic Control: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IRB00006564'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin infusion conversion equation', 'description': 'Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.', 'interventionNames': ['Other: IICE Dosing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': "Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.", 'interventionNames': ['Other: Healthcare Provider dosing']}], 'interventions': [{'name': 'IICE Dosing', 'type': 'OTHER', 'description': "Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement. If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart. If patient was not eating, 100% of ISC was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \\[3 x scheduled aspart dose\\]). For BG \\< 70 mg/dL, ½ ampule D50W IV x1 was given.", 'armGroupLabels': ['Insulin infusion conversion equation']}, {'name': 'Healthcare Provider dosing', 'type': 'OTHER', 'description': "Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider. If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider. If patient was not eating, 100% of insulin was given as insulin glargine. If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation. Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + \\[3 x scheduled aspart dose\\]). For BG \\< 70 mg/dL, ½ ampule D50W IV x1 was given.", 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Crawford Long Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Gregory R Smith, Jr., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'G. Randy Smith, Jr., M.D.', 'investigatorAffiliation': 'Emory University'}}}}