Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-05-27 @ 4:41 AM
Study NCT ID:
NCT03683368
Status:
COMPLETED
Last Update Posted:
2019-03-29
First Post:
2018-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extended Wear of a Steel and a Teflon Insulin Infusion 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': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-28', 'studyFirstSubmitDate': '2018-09-20', 'studyFirstSubmitQcDate': '2018-09-24', 'lastUpdatePostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to infusion set failure due to an occlusion', 'timeFrame': 'up to 7 days', 'description': 'an occlusion is defined by blood ketone concentration is \\> or = 0.6 mmol/l with blood glucose (BG) concentration \\>250 mg/dl, or BG concentration is \\>250 mg/dl for more than 2 h and a subsequent correction bolus failed, or pump occlusion alarm that cannot be fixed.'}], 'secondaryOutcomes': [{'measure': 'Frequency of early infusion set changes', 'timeFrame': 'up to 7 days'}, {'measure': 'Time to early infusion set changes', 'timeFrame': 'up to 7 days'}, {'measure': 'Frequency of early infusion set changes due to infusion site infection', 'timeFrame': 'up to 7 days'}, {'measure': 'Median infusion set wearing time', 'timeFrame': 'up to 7 days'}, {'measure': 'Daily mean glucose', 'timeFrame': 'day 1, 2, 3, 4, 5, 6, 7', 'description': 'Based on Continuous Glucose Monitoring'}, {'measure': 'Daily mean glucose', 'timeFrame': 'day 1, 2, 3, 4, 5, 6, 7', 'description': 'Based on self measured blood glucose'}, {'measure': 'Total daily insulin dose', 'timeFrame': 'day 1, 2, 3, 4, 5, 6, 7'}, {'measure': 'Glucose variability', 'timeFrame': 'day 1, 2, 3, 4, 5, 6, 7', 'description': 'Coefficient of variation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'This is a cross-over study to evaluate if insulin infusion sets can be used up to 7 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of type 1 diabetes for at least 12 months\n* Using an insulin pump for at least 12 months\n* Age ≥18 years\n* Hemoglobin A1c level less than or equal to 8.5%\n* Willing to use mylife™ YpsoPump® system while they are participating in the study\n* Willing to use NovoRapid® insulin while they are participating in the study\n* An understanding of and willingness to follow the protocol and sign the informed consent\n\nExclusion Criteria:\n\n* Diabetic ketoacidosis in the past 3 months prior to enrollment\n* Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment\n* Urea, Creatinine, ALT more than three times the upper limit of normal, or thrombocytopenia (\\<150 G/l)\n* Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of menopause, sterilization or hysterectomy), or unwilling to use an acceptable form of contraception during the study (for sexually active subjects of childbearing potential)\n* Known severe tape reactions or allergies\n* Known severe nickel allergies\n* History of frequent catheter abscesses associated with pump therapy\n* Serious acute or chronic disease besides diabetes mellitus or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject, e.g. seizure disorder, adrenal disorder, dialysis for renal failure, cystic fibrosis, active infection\n* Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g. mental or visual incapacity, language barriers, alcohol or drug misuse\n* Dependency from the sponsor or the clinical investigator'}, 'identificationModule': {'nctId': 'NCT03683368', 'briefTitle': 'Extended Wear of a Steel and a Teflon Insulin Infusion Set', 'organization': {'class': 'INDUSTRY', 'fullName': 'mylife Diabetes Care AG'}, 'officialTitle': 'Extended Wear of a Steel and a Teflon Insulin Infusion Set', 'orgStudyIdInfo': {'id': 'YPU105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Soft cannula first', 'description': 'Subjects will be randomized (50%) to the soft cannula infusion set for two weeks and then will be switched to the steel needle infusion set for two additional weeks. Participants will aim for 7 day use of each infusion set type twice, starting with the soft cannula infusion set.', 'interventionNames': ['Device: YpsoPump Orbit soft', 'Device: YpsoPump Orbit micro']}, {'type': 'EXPERIMENTAL', 'label': 'Steel cannula first', 'description': 'Subjects will be randomized (50%) to the steel cannula infusion set for two weeks and then will be switched to the soft cannula infusion set for two additional weeks. Participants will aim for 7 day use of each infusion set type twice, starting with the steel cannula infusion set.', 'interventionNames': ['Device: YpsoPump Orbit soft', 'Device: YpsoPump Orbit micro']}], 'interventions': [{'name': 'YpsoPump Orbit soft', 'type': 'DEVICE', 'description': 'Insulin infusion sets will be used for up to 7 days or until failure', 'armGroupLabels': ['Soft cannula first', 'Steel cannula first']}, {'name': 'YpsoPump Orbit micro', 'type': 'DEVICE', 'description': 'Insulin infusion sets will be used for up to 7 days or until failure', 'armGroupLabels': ['Soft cannula first', 'Steel cannula first']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Guido Freckmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm'}, {'name': 'Andreas Buhr, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ypsomed AG, Burgdorf, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'mylife Diabetes Care AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}