Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT00892151
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2009-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of GLUCOFACTS® Deluxe Diabetes Management System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'carmine.greene@ascensia.com', 'phone': '574-257-3040', 'title': 'Carmine Greene, Senior Clinical Research Scientist', 'organization': 'Ascensia Diabetes Care'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Intended Users of the Software', 'description': '10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.', 'otherNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Rated Successful (<=3) at Performing Specific Tasks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intended Users of the Software', 'description': '10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.'}], 'classes': [{'title': 'Start Glucofacts® Deluxe', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Set up Patient Profile (New User)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Download CONTOUR meter', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': "Display the 'standard day' report", 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Display the logbook', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Enter a Hemoglobin A1c result to the logbook', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Find A1c result in logbook', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Change Blood sugar (BS) ranges in the software', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Change personal BS ranges in the CONTOUR meter', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Change CONTOUR meter settings', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Download CONTOUR USB meter', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': "Display the 'Summary' report", 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Change CONTOUR USB meter HI and LO settings', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Change CONTOUR USB meter trends length', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Change default BS ranges for patients (HCPs only)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Find patient in database / view data (HCPs only)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-2 hours', 'description': 'Study staff rated participants on their success at perfoming specific tasks. The rating scale was:\n\n1. = Successful\n2. = Successful after being referred to user instructions\n3. = Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)\n4. = Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)\n5. = Problem encountered with software', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: 2 tasks were performed only by the 10 healthcare professionals. Also, one lay person was withdrawn (leaving 50 participants). The subject was a parent of a child with diabetes;the 17 year old child performed the software evaluation instead of the parent. Data for the subject withdrawn from the study was not used in the analysis.', 'anticipatedPostingDate': '2010-04'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intended Users of the Software', 'description': '10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.'}], 'classes': [{'title': 'Start Glucofacts® Deluxe', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Set up Patient Profile (New User)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Download CONTOUR meter', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': "Display the 'standard day' report", 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}, {'title': 'Display the logbook', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Enter a Hemoglobin A1c result to the logbook', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'Find A1c result in logbook', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'Change Blood sugar (BS) ranges in the software', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}, {'title': 'Change personal BS ranges in the CONTOUR meter', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}, {'title': 'Change CONTOUR meter settings', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}, {'title': 'Download CONTOUR USB meter', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}]}]}, {'title': "Display the 'Summary' report", 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Change CONTOUR USB meter HI and LO settings', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}]}]}, {'title': 'Change CONTOUR USB meter trends length', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}, {'title': 'Change default BS ranges for patients (HCPs only)', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'Find patient in database / view data (HCPs only)', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-2 hours', 'description': 'Subjects rated ease of using the software with respect to specific tasks. The rating scale was:\n\n1. = Very Simple\n2. = Simple\n3. = Neither Simple nor Difficult\n4. = Difficult\n5. = Very Difficult', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Note: 2 tasks were performed only by the 10 healthcare professionals. Also, one lay person was withdrawn (leaving 50 participants). The subject was a parent of a child with diabetes; the 17 year old child performed the software evaluation instead of the parent. Data for the subject withdrawn from the study was not used in the analysis.', 'anticipatedPostingDate': '2010-04'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intended Users of the Software', 'description': '10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.'}], 'classes': [{'title': 'Clarity of instructions in User Guide (n=33)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Clarity-instruct in Quick Reference Guide (n=35)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Clarity of the online help (n=35)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Usefulness of instructions in User Guide (n=30)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Usefulness-instructions Quick Reference Guide(33)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Usefulness of the online help (n=31)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1-2 hours', 'description': 'User instructions included online help, User Guide, and a Quick Reference Guide. Subjects rated their clarity and usefulness and the rating scale was:\n\n1. = Unacceptable\n2. = Poor\n3. = Good\n4. = Very Good\n5. = Excellent', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Some subjects had no opinion; the number of subjects that did respond with ratings are identified in parentheses.', 'anticipatedPostingDate': '2010-04'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intended Users of the Software', 'description': '10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'One subject was withdrawn for non-compliance. The subject was a parent of a child with diabetes and the 17 year old child was performing the software evaluation instead of the parent. The protocol states that the subjects were to be 18 years and older. The subject was withdrawn from the study and the data was not used in the analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intended Users of the Software', 'description': 'Baseline measures apply to lay persons (n=40) not healthcare professionals in the study.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '67'}]}]}], 'paramType': 'MEDIAN', 'description': 'Baseline measures apply to lay persons (n=40) not healthcare professionals in the study. Ages ranged from 18 to 67 years.', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-29', 'studyFirstSubmitDate': '2009-05-01', 'resultsFirstSubmitDate': '2010-04-15', 'studyFirstSubmitQcDate': '2009-05-01', 'lastUpdatePostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-04-15', 'studyFirstPostDateStruct': {'date': '2009-05-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Rated Successful (<=3) at Performing Specific Tasks', 'timeFrame': '1-2 hours', 'description': 'Study staff rated participants on their success at perfoming specific tasks. The rating scale was:\n\n1. = Successful\n2. = Successful after being referred to user instructions\n3. = Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)\n4. = Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)\n5. = Problem encountered with software'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3', 'timeFrame': '1-2 hours', 'description': 'Subjects rated ease of using the software with respect to specific tasks. The rating scale was:\n\n1. = Very Simple\n2. = Simple\n3. = Neither Simple nor Difficult\n4. = Difficult\n5. = Very Difficult'}, {'measure': 'Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3', 'timeFrame': '1-2 hours', 'description': 'User instructions included online help, User Guide, and a Quick Reference Guide. Subjects rated their clarity and usefulness and the rating scale was:\n\n1. = Unacceptable\n2. = Poor\n3. = Good\n4. = Very Good\n5. = Excellent'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate a Diabetes management program in the hands of potential users, both health care professionals and lay persons.', 'detailedDescription': "Diabetes data management programs upload glucose meter results to computers to provide information at home to lay people with diabetes and their healthcare professionals to manage their diabetes. The study evaluated the subjects' success using the software program with a blood glucose meter to perform specific tasks, such as uploading the meter results, changing program and meter settings, and displaying reports. The study also evaluated the system's ease of use and the acceptability of product labeling."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nLay users must:\n\n* Be at least 18 years of age (at least 80% must be 55 years or less)\n* Have diabetes or be the parent or legal guardian of a child with diabetes who routinely test their blood sugar at home\n* Be testing blood sugar at home at least twice daily for at least one month or be the parent or legal guardian of a child who has been testing blood sugar at home at least twice daily for at least one month\n* Be able to speak, read, and understand English\n* Have experience using PC programs or browsing the internet\n* Have utilized diabetes management software at home in the last year (at least 75% of lay users) or be familiar with diabetes management software\n\nHCPs must:\n\n* Have experience using diabetes data management software in the medical office or assist in patients' diabetes disease management using software\n\nExclusion Criteria:\n\n* Person working for a competitive medical device company\n* Person having a cognitive disorder or condition which, in the opinion of the investigator, would put the person at risk or compromise the integrity of the study."}, 'identificationModule': {'nctId': 'NCT00892151', 'briefTitle': 'Evaluation of GLUCOFACTS® Deluxe Diabetes Management System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascensia Diabetes Care'}, 'officialTitle': 'Evaluation of GLUCOFACTS® Deluxe Diabetes Management System In a Clinical Setting', 'orgStudyIdInfo': {'id': 'CTD-2009-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intended Users of the Software', 'description': '10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) using a diabetes data management program.', 'interventionNames': ['Device: GLUCOFACTS® Deluxe']}], 'interventions': [{'name': 'GLUCOFACTS® Deluxe', 'type': 'DEVICE', 'description': 'Diabetes Data Management Software', 'armGroupLabels': ['Intended Users of the Software']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92026', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'AMCR Institute', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}], 'overallOfficials': [{'name': 'Timothy Bailey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AMCR Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascensia Diabetes Care', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}