Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2026-02-28 @ 8:19 AM
Study NCT ID:
NCT02779816
Status:
TERMINATED
Last Update Posted:
2019-08-14
First Post:
2016-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adaptive Device for Insulin Pens for Arthritic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D001168', 'term': 'Arthritis'}], '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'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Lack of sufficient recruitment, other priorities', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2016-05-15', 'studyFirstSubmitQcDate': '2016-05-19', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog scale for ease of use', 'timeFrame': 'one month', 'description': 'Questionnaires re: efficacy and ease of use'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Arthritis'], 'conditions': ['Diabetes Mellitus', 'Arthritis']}, 'descriptionModule': {'briefSummary': 'Approximately 34 subjects will be enrolled in an unblinded cross-over design. For one week, they will use the adaptive pen device and for the next week, they will use just the insulin (or other medication) pen. This will be repeated for another one week period each. At the end of each week, the subjects will fill out a questionnaire regarding their experiences and any suggestions for improvements for the design of the pen device.', 'detailedDescription': 'This study is of an unblinded crossover design. Each patient will be randomly assigned to initiate a one week observation period with either the pen alone or the pen with the device. The following week, the patient will switch to the other assignment. This will be repeated one more time for a total of two weeks with the device and two weeks without it.\n\nAt the end of every week, the patients will be given a questionnaire to fill out. Questions will include a measurement of their satisfaction with their insulin (or other medication) delivery system for that week. Patients will be instructed to continue their usual dosage of medication as prescribed by their physician. If the patients have any problems with the device or feel uncomfortable with it, they are instructed to discontinue use of the device and continue using their pen as usual.\n\nThe patients may keep the device at the end of the study. The questionnaires that the patients fill out will be the primary source documents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Currently using a pen to administer medication at least once a week\n* Currently are having some difficulty (self reported) using their pens because of dexterity issues\n\nExclusion Criteria:\n\n* Woman of child-bearing age who are known to be pregnant\n* People who are unable or unwilling to sign the informed consent document\n* Patients who do not understand the proper use of the device after sufficient instruction\n* Anyone in the Principal Investigator's judgment who cannot properly use the device"}, 'identificationModule': {'nctId': 'NCT02779816', 'briefTitle': 'Adaptive Device for Insulin Pens for Arthritic Patients', 'organization': {'class': 'INDIV', 'fullName': 'Levenson, David I., M.D.'}, 'officialTitle': 'Exploring the Utility of a Novel Adaptive Device for Commercially Available Insulin Pens in Patients With Arthritis or Hand Deformities', 'orgStudyIdInfo': {'id': '2016-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention (pen device)', 'description': 'Subjects will use the pen device when using their commercially available insulin pens', 'interventionNames': ['Device: Pen device']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Subjects will use the commercially available insulin pens only (no adaptive pen device).'}], 'interventions': [{'name': 'Pen device', 'type': 'DEVICE', 'description': 'Adaptive pen device', 'armGroupLabels': ['Intervention (pen device)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33433', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'East Coast Medical Associates', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}], 'overallOfficials': [{'name': 'David I Levenson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'East Coast Medical Associates'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not until a patent is approved; after that, upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Levenson, David I., M.D.', 'class': 'INDIV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'David I. Levenson, MD', 'investigatorAffiliation': 'Levenson, David I., M.D.'}}}}