Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT01024218
Status:
COMPLETED
Last Update Posted:
2017-02-24
First Post:
2009-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preference Study Between NovoFine® Autocover™ and a NovoFine® 8 mm Needle
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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2005-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-22', 'studyFirstSubmitDate': '2009-11-30', 'studyFirstSubmitQcDate': '2009-11-30', 'lastUpdatePostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device preference', 'timeFrame': 'after 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Comparison of the adverse device effects (occlusion/activation/locking problems/manufacturing defects)'}, {'measure': 'Comparison of the frequency of adverse device effects'}, {'measure': 'Comparison of the frequency of adverse events (needle stick injuries)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Healthcare Professionals', 'Delivery Systems']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. The aim of this clinical trial is to assess the preference of 2 different needles used by nurses and health assistants. The trial consists of a handling test followed by a 12 week cross-over study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The participant must have been either a diabetes nurse or a diabetes health assistant with competence in subcutaneous injections of insulin for at least 4 weeks\n* Participants must demonstrate proficiency with the injection device in the handling test prior to testing the NovoFine® Autocover™ Needle in patients'}, 'identificationModule': {'nctId': 'NCT01024218', 'briefTitle': 'Preference Study Between NovoFine® Autocover™ and a NovoFine® 8 mm Needle', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'An Open-label, Multicenter, Handling Test and Prospective Cross-over Study on Nurse/Health Assistants Preference Between NovoFine® Autocover™ and 8 mm NovoFine® Needle', 'orgStudyIdInfo': {'id': 'AUTOCOVER'}}, 'armsInterventionsModule': {'interventions': [{'name': 'NovoFine® needle 8 mm', 'type': 'DEVICE'}, {'name': 'autocover needle', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}