Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-11 @ 7:38 PM
Study NCT ID:
NCT03242005
Status:
WITHDRAWN
Last Update Posted:
2017-09-14
First Post:
2017-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The PSIQS Study - User Experience With Pro-Set
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor decision to not proceed with study - no subjects enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-12', 'studyFirstSubmitDate': '2017-08-04', 'studyFirstSubmitQcDate': '2017-08-04', 'lastUpdatePostDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare Pro-set® vs. Quick-set® for non-inferiority for set insertion failures (set removal) due to either occlusion alerts or hyperglycemia', 'timeFrame': '6 hours from time of insertion'}], 'secondaryOutcomes': [{'measure': 'Compare Pro-set® vs. Quick-set® for set removals due to hyperglycemia; > 400mg/dl.', 'timeFrame': '6 hours from time of insertion'}, {'measure': 'Compare Pro-set® vs. Quick- set® for set removals due to set failure; hyperglycemia >250mg/dl.', 'timeFrame': '72 hours of set wear that occurs at 6 hours or later after insertion'}, {'measure': 'Compare Pro-set® vs. Quick- set® for set removals at less than 60 hours post insertion.', 'timeFrame': '60 hours post insertion'}, {'measure': 'Compare Pro-set® vs. Quick- set® for duration of wear', 'timeFrame': '% reaching 12 hours, % reaching 24 hours, % reaching 36 hours, % reaching 48 hours, % reaching 60 hours, and % reaching 72 hours)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'Open label, randomized 2-period cross-over study comparing two continuous subcutaneous insulin infusion sets ; MiniMed® Pro-set® with BD FlowSmart™ technology and MiniMed® Quick-set®'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be between 13 and 70 years of age (inclusive)\n* Must have been previously diagnosed with type 1 diabetes mellitus\n* Must be using one of the following Medtronic insulin pumps with the Paradigm connector (note 670G excluded) for at least 6 months prior to enrollment. These pumps must have the ability to upload data to Medtronic CareLink Therapy Management software.\n\n 1. MiniMed Paradigm Revel™ Insulin Pump - models 523 (1.8 mL reservoir) and 723 (3 mL reservoir)\n 2. MiniMed 530G Pump - models 551 (1.8 mL reservoir) and 751 (3 mL reservoir)\n 3. MiniMed 630G System\n* Must have been using the Medtronic Enlite CGM for at least 3 months prior to enrollment, and are currently doing so\n* Must routinely insert their own infusion set (may be inserted manually or with an inserter or with an integrated set/inserter, i.e. Mio)\n* If instructed, must be willing to insert all assigned infusion sets with a mechanical inserter\n* Must have another form of insulin delivery available (i.e. vial and syringe or pen and pen needle)\n* Must agree to continue using current Medtronic Enlite CGM throughout the study\n* Willing to have insulin pump, BGM and CGM data downloaded into Medtronic CareLink Therapy Management Software (requires subject CareLink logon ID and password)\n* In stable health status with no acute or significant illness, in the opinion of the investigator or designee\n* Able to read, write and follow instructions in English\n* Able and willing to provide informed consent\n* Able and willing to comply with study procedures\n\nExclusion Criteria:\n\n* Pregnant (self-attestation) or nursing\n* Currently using a body-worn patch insulin infusion pump, e.g. Omnipod or V-Go\n* Currently using the Medtronic Model 670G pump and associated CGM\n* Current or past participation in previous BD Study DBC-16SCARL21\n* History of bleeding disorder or easy bruising.\n* Currently taking anti-platelet therapy or anticoagulants (use of up to 81 mg per day of aspirin is permitted).\n* Known blood borne infections.\n* History of recurrent dermatological condition or skin disorder (e.g. psoriasis, eczema, pre-existing dermatitis).\n* Skin abnormalities, anomalies or conditions (e.g. sunburn, tattoos, extensive scarring, lipohypertrophy) located at or very close to the intended insertion site.\n* Physical condition that restricts dexterity and may limit ability to perform study procedures (i.e. severe neuropathy or arthritis of the hands; self-reported)\n* Currently participating in any other clinical investigation that conflicts with this study\n* Employed by, or currently serving as a contractor or consultant to BD, Medtronic or study site\n* Any other condition the investigator or designee deems to pose an unacceptable risk to the subject in the study'}, 'identificationModule': {'nctId': 'NCT03242005', 'briefTitle': 'The PSIQS Study - User Experience With Pro-Set', 'organization': {'class': 'INDUSTRY', 'fullName': 'Becton, Dickinson and Company'}, 'officialTitle': 'The PSIQS Study - User Experience With the Pro-Set Over Intended Wear of 3 Days With New Instructions and Requirement to be Inserted With the Quick-Serter', 'orgStudyIdInfo': {'id': 'DBC-17SCARL23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pro-set® vs. Quick-set®', 'description': 'Subjects will be randomized to start with one of the study subcutaneous insulin administration sets (MiniMed® Pro-set® or MiniMed® Quick-set®). After completing the first study period,subjects will be placed in the alternative group according to the cross-over study design.', 'interventionNames': ['Device: MiniMed® Pro-set®', 'Device: MiniMed® Quick-set®']}], 'interventions': [{'name': 'MiniMed® Pro-set®', 'type': 'DEVICE', 'description': "Utilization of the MiniMed® Pro-set® to administer the subject's current insulin therapy.", 'armGroupLabels': ['Pro-set® vs. Quick-set®']}, {'name': 'MiniMed® Quick-set®', 'type': 'DEVICE', 'description': "Utilization of the MiniMed® Quick-set® to administer the subject's current insulin therapy.", 'armGroupLabels': ['Pro-set® vs. Quick-set®']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Becton, Dickinson and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}