Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-25 @ 7:04 PM
Study NCT ID:
NCT01763567
Status:
COMPLETED
Last Update Posted:
2015-05-07
First Post:
2012-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Feasibility Study to Evaluate Safety and Device Performance of the Hospital Glucose Management System (HGMS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Julie.Sekella@medtronic.com', 'phone': '818-576-5000', 'title': 'Julie Sekella', 'organization': 'Medtronic, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 days for each subject', 'eventGroups': [{'id': 'EG000', 'title': 'Observation Arm', 'description': 'To assess safety and device performance for the Hospital Glucose Managment system', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Device Performance: Accuracy of HGMS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oberservation Arm', 'description': 'To assess safety and device performance for the Hospital Glucose Managment system'}], 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'spread': '9.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '12.8', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '9.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'up to 72 hours', 'description': 'Mean Absolute Relative Difference (MARD), calculated as the absolute difference of \\[(sensor glucose values - iSTAT glucose values) / iSTAT glucose values\\].\n\nThe portable i-STAT handheld makes patient-side testing easy:\n\n* Requires no special sample preparation or user calibration; maintenance is minimal\n* Weighs 18 ounces, making it portable\n* Patient-side testing is as easy as entering the operator and patient information into the handheld, inserting one of the several filled test cartridges, and then viewing test results:\n* The system prompts users step by step through the testing process\n* Operator and patient information can be entered via barcode scanner\n* Operator lockout prevents unauthorized users from performing or viewing test results\n* Test results are uploaded automatically when the i-STAT handheld is placed in a downloader', 'unitOfMeasure': 'percent difference', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'To assess safety and device performance for the Hospital Glucose Managment system'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Functionality of HGMS: Alerts and Alarms - % of Hypo Events Correctly Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oberservation Arm', 'description': 'To assess safety and device performance for the Hospital Glucose Managment system'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'percent of events correctly detected', 'ciNumSides': 'TWO_SIDED', 'paramValue': '16.7', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 72 hours', 'description': 'The device alarmed within 30 minutes before or after the reference blood glucose value (i-STAT) goes below 70 mg/dL setting levels. The % of hypo events correctly detected was calculated as: total number of correct events divided by total number of events from all 19 participants.', 'unitOfMeasure': 'percentage of total events', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Functionality of HGMS: Alerts and Alarms - % of Hyper Events Correctly Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oberservation Arm', 'description': 'To assess safety and device performance for the Hospital Glucose Managment system'}], 'classes': [{'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'percent of events correctly detected', 'ciNumSides': 'TWO_SIDED', 'paramValue': '88.9', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '72 hours', 'description': 'The device alarmed within 30 minutes before or after the reference blood glucose value (i-STAT) goes above 250 mg/dL setting levels. The % of hyper events correctly detected was calculated as: total number of correct events divided by total number of events from all 19 participants.', 'unitOfMeasure': 'percentage of total events', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Functionality of HGMS: Alerts and Alarms - % of Hypo False Alert', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oberservation Arm', 'description': 'To assess safety and device performance for the Hospital Glucose Managment system'}], 'classes': [{'categories': [{'measurements': [{'value': '85.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': '% of false alert', 'ciNumSides': 'TWO_SIDED', 'paramValue': '85.8', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 hours', 'description': 'Definition of % of hypo false alert: within 30 minutes before or after the sensor alarmed at 70 mg/dL, there is no reference blood glucose value (i-STAT) that goes below 70 mg/dL. The % of hypo false alert was calculated as: total number of false events divided by total number of events from all 19 participants. NOTE: % of Hypo False Alert and % Hypo Event Correctly Detected do not necessarily add up to 100% because the denomintors are not the same.', 'unitOfMeasure': 'percentage of all alerts', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Functionality of HGMS: Alerts and Alarms - % of Hyper False Alert', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oberservation Arm', 'description': 'To assess safety and device performance for the Hospital Glucose Managment system'}], 'classes': [{'categories': [{'measurements': [{'value': '56.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': '% of false alert', 'ciNumSides': 'TWO_SIDED', 'paramValue': '56.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 hours', 'description': 'Definition of % of Hyper False Alert: within 30 minutes before or after the sensor alarmed at 250 mg/dL, there is no reference blood glucose value (i-STAT) that goes above 250mg/dL . The % of hyper false alert was calculated as: total number of false events divided by total number of events from all 19 participants. NOTE: % of Hyper False Alert and % Hyper Event Correctly Detected do not necessarily add up to 100% because the denomintors are not the same.', 'unitOfMeasure': 'percentage of all alerts', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oberservation Arm', 'description': 'To assess safety and device performance for the Hospital Glucose Managment system'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Oberservation Arm', 'description': 'To assess safety and device performance for the Hospital Glucose Managment system'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.2', 'spread': '12.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-05', 'studyFirstSubmitDate': '2012-12-21', 'resultsFirstSubmitDate': '2014-10-14', 'studyFirstSubmitQcDate': '2013-01-04', 'lastUpdatePostDateStruct': {'date': '2015-05-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-05', 'studyFirstPostDateStruct': {'date': '2013-01-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Functionality of HGMS: Alerts and Alarms - % of Hypo Events Correctly Detected', 'timeFrame': 'up to 72 hours', 'description': 'The device alarmed within 30 minutes before or after the reference blood glucose value (i-STAT) goes below 70 mg/dL setting levels. The % of hypo events correctly detected was calculated as: total number of correct events divided by total number of events from all 19 participants.'}, {'measure': 'Functionality of HGMS: Alerts and Alarms - % of Hyper Events Correctly Detected', 'timeFrame': '72 hours', 'description': 'The device alarmed within 30 minutes before or after the reference blood glucose value (i-STAT) goes above 250 mg/dL setting levels. The % of hyper events correctly detected was calculated as: total number of correct events divided by total number of events from all 19 participants.'}, {'measure': 'Functionality of HGMS: Alerts and Alarms - % of Hypo False Alert', 'timeFrame': 'Up to 72 hours', 'description': 'Definition of % of hypo false alert: within 30 minutes before or after the sensor alarmed at 70 mg/dL, there is no reference blood glucose value (i-STAT) that goes below 70 mg/dL. The % of hypo false alert was calculated as: total number of false events divided by total number of events from all 19 participants. NOTE: % of Hypo False Alert and % Hypo Event Correctly Detected do not necessarily add up to 100% because the denomintors are not the same.'}, {'measure': 'Functionality of HGMS: Alerts and Alarms - % of Hyper False Alert', 'timeFrame': 'Up to 72 hours', 'description': 'Definition of % of Hyper False Alert: within 30 minutes before or after the sensor alarmed at 250 mg/dL, there is no reference blood glucose value (i-STAT) that goes above 250mg/dL . The % of hyper false alert was calculated as: total number of false events divided by total number of events from all 19 participants. NOTE: % of Hyper False Alert and % Hyper Event Correctly Detected do not necessarily add up to 100% because the denomintors are not the same.'}], 'primaryOutcomes': [{'measure': 'Device Performance: Accuracy of HGMS', 'timeFrame': 'up to 72 hours', 'description': 'Mean Absolute Relative Difference (MARD), calculated as the absolute difference of \\[(sensor glucose values - iSTAT glucose values) / iSTAT glucose values\\].\n\nThe portable i-STAT handheld makes patient-side testing easy:\n\n* Requires no special sample preparation or user calibration; maintenance is minimal\n* Weighs 18 ounces, making it portable\n* Patient-side testing is as easy as entering the operator and patient information into the handheld, inserting one of the several filled test cartridges, and then viewing test results:\n* The system prompts users step by step through the testing process\n* Operator and patient information can be entered via barcode scanner\n* Operator lockout prevents unauthorized users from performing or viewing test results\n* Test results are uploaded automatically when the i-STAT handheld is placed in a downloader'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Medtronic', 'Diabetes', 'Hospital', 'Continuous Glucose Monitor', 'Intensive Care Unit'], 'conditions': ['Hyperglycemia']}, 'referencesModule': {'references': [{'pmid': '25452874', 'type': 'DERIVED', 'citation': 'Kosiborod M, Gottlieb RK, Sekella JA, Peterman D, Grodzinsky A, Kennedy P, Borkon MA. Performance of the Medtronic Sentrino continuous glucose management (CGM) system in the cardiac intensive care unit. BMJ Open Diabetes Res Care. 2014 Jul 21;2(1):e000037. doi: 10.1136/bmjdrc-2014-000037. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess safety and device performance of the Medtronic Hospital Glucose Management System (HGMS) for up to 72-hours.', 'detailedDescription': 'Assess safety and device performance of the Medtronic HGMS in the critically-ill setting and analyze the following:\n\n1. Device Performance:\n\n * Functionality of HGMS\n * Alerts/Alarms Specificity and Sensitivity\n * System Workflow\n2. Safety:\n\n * Descriptive statistics will be used to characterize safety events\n * Moderate and severe anticipated device and procedure related adverse events\n * All serious adverse events and unanticipated adverse device effects related events'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients admitted to the Intensive Care Unit (ICU) and on intravenous (IV) insulin therapy for the treatment of transient or diabetes-related hyperglycemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is at least 18 years old\n2. Subject is admitted to the ICU\n3. Subject has a treatment regimen that includes a glucose target range of ≥140 mg/dl\n4. Subject has a treatment regimen that includes an intended continuous intravenous insulin for at least 24 hours\n\n a. Including patients with no previous diagnosis of Diabetes Mellitus\n5. Subject has anticipated life expectancy greater than 96 hours\n6. Subject has recent platelet count greater than 30,000 per micro-liter\n\nExclusion Criteria:\n\n1. Subject currently has a suspected or diagnosed medical condition that, in the opinion of the Investigator, warrants exclusion from the study or prevents the subject from completing the study\n2. Subject is currently participating in another investigational drug or device study\n3. Subject is pregnant, as determined by hospital admission\n4. Subject is receiving treatment that includes Hydroxyurea.'}, 'identificationModule': {'nctId': 'NCT01763567', 'acronym': 'MAHI', 'briefTitle': 'Feasibility Study to Evaluate Safety and Device Performance of the Hospital Glucose Management System (HGMS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Diabetes'}, 'officialTitle': 'A Multi-Phased, Multi-Center Study to Evaluate Safety and Device Performance of the Medtronic Hospital Glucose Management System (HGMS) in Critically Ill Adult Patients', 'orgStudyIdInfo': {'id': 'CEP244'}}, 'contactsLocationsModule': {'locations': [{'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "St Luke's Hospital Mid America Heart Institute", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Mikhail Kosiborod, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St Luke's Hospital - Mid America Heart Institute"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Diabetes', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}