Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-26 @ 6:41 PM
Study NCT ID:
NCT01142895
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
2010-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation Study of G4 User Interface
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'lastUpdateSubmitDate': '2010-06-10', 'studyFirstSubmitDate': '2010-06-09', 'studyFirstSubmitQcDate': '2010-06-10', 'lastUpdatePostDateStruct': {'date': '2010-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this simulated useability study is to demonstrate the user interface and software design mitigate potential safety concerns.', 'detailedDescription': 'These are the detailed descriptive planned outcomes of this useability study.\n\n* To demonstrate that human-interface design mitigations lead to effective, efficient, and safe use.\n* Validate that foreseeable misuse does not lead to a safety hazard or patient injury.\n* Validate the effectiveness and comprehension of critical warnings and alerts, including vibratory, auditory, and textual cues.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Novice adult pumpers, experienced adult pumpers, and non-pumper adults', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT01142895', 'acronym': 'G4', 'briefTitle': 'Validation Study of G4 User Interface', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tandem Diabetes Care, Inc.'}, 'officialTitle': 'Simulated Usability Trial of the T-Slim Ambulatory Insulin Infusion Pump', 'orgStudyIdInfo': {'id': 'TDC-G4'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tandem Diabetes Care, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Kathryn Rieger', 'oldOrganization': 'Tandem Diabetes care, Inc.'}}}}