Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2026-01-06 @ 8:49 PM
Study NCT ID:
NCT06684561
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-12
First Post:
2024-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EARLY FEASIBILITY STUDY: SAFETY AND EFFICACY OF PHOTON 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-11', 'studyFirstSubmitDate': '2024-11-11', 'studyFirstSubmitQcDate': '2024-11-11', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Effectiveness Endpoint', 'timeFrame': '12 months', 'description': 'The primary outcome is to have no more than 16% of infusion set failures due to "unexplained hyperglycemia" Definition of unexplained hyperglycemia: o The study meter glucose \\>250 mg/dL (\\>3 hours post-meal) which may include time during subject\'s sleeping hours.\n\n* Failure of a correction dose(s) to lower the study meter glucose by at least 50 mg/dL within 1 hour.\n* One additional correction dose may be given after first correction dose and recommended to use the bolus calculator'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infusion sets', 'insulin pumps', 'AID system'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': "Study 1:\n\nThe purpose of this study is to evaluate safety and efficacy of Photon infusion sets (PIS) with new PFAS-free cannula (catheter) in adult patients with Type 1 diabetes for up to 10 days and 6 hours.\n\nThis is a 1-center, prospective, open-label, 1-arm study with type 1 patients with diabetes on 780G insulin pump therapy with Guardian™ 4 Continuous Glucose Monitoring (CGM). All subjects will be instructed to change infusion sets every 246 hours (10 days \\& 6 hours) or at set failure. Each subject is required to wear the CGM device continuously.\n\nAfter completing 2 sets, the subjects have an optional office visit to download pump and CGM data and will continue to additional two wears. At day 40 or after using 4 completed wears of infusion sets (Note: early infusion set failure with wear time of \\<6 hours due to insertion failure will be reported, yet not accounted as completed wear), the patients will return to a visit, download pump and CGM data, and end the study.\n\nPhoton infusion sets with 6-mm and 9-mm cannula length will be supplied for this study, with selection based on subjects' needs and doctor's recommendation. Subjects will change insulin reservoirs at least every 7 days (the labelled wear duration of the Extended reservoir). The infusion set(s) or reservoir(s) can be replaced independent of each other. The date and time of each infusion set insertion will be recorded in a Daily Log (Diary) which will include the causes of early removal, if occurs.\n\nStudy 2: If Study 1 is successful, the same study designed as illustrated in Figure 1 may be performed on the current on-market Extended infusion set (EIS) for comparison of clinical performance with the PIS, using the same cohort of pump users."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of type 1 diabetes for at least one year\n2. Using a MiniMed™ 780G Insulin pump with Guardian sensor\n3. Age 18 to 80 years\n4. Hemoglobin A1c level less than or equal to 10%\n5. Not currently known to be pregnant, nor planning pregnancy during the study.\n6. Willingness to follow the protocol and sign the informed consent\n\nExclusion Criteria:\n\n1. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.\n2. Pregnant or lactating females\n3. Subject has Glycosylated hemoglobin (HbA1c)\\< 10 % at time of screening.'}, 'identificationModule': {'nctId': 'NCT06684561', 'briefTitle': 'EARLY FEASIBILITY STUDY: SAFETY AND EFFICACY OF PHOTON INFUSION SET', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'EARLY FEASIBILITY STUDY: SAFETY AND EFFICACY OF PHOTON INFUSION SET', 'orgStudyIdInfo': {'id': 'Sheba-24-1530-AT-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'All subjects will be instructed to change the investigational infusion sets (PIS) every 246 hours (10 days \\& 6 hours) or at set failure. Each subject is required to wear the CGM device continuously.\n\ndefined as any one of the following: After completing 2 sets, the subjects have an optional office visit to download pump and CGM data and will continue to additional two wears. At day 40 or after using 4 completed wears of infusion sets (Note: early infusion set failure with wear time of \\<6 hours due to insertion failure will be reported, yet not accounted as completed wear), the patients will return to a visit, download pump and CGM data, and end the study.\n\nif study 1 is successful, participants will enter study 2; , the same study designed will be performed on the current on-market Extended infusion set (EIS) for comparison of clinical performance with the PIS, using the same cohort of pump users', 'interventionNames': ['Device: PIS']}], 'interventions': [{'name': 'PIS', 'type': 'DEVICE', 'description': 'All subjects will be instructed to change the investigational infusion sets (PIS) every 246 hours (10 days \\& 6 hours) or at set failure. Each subject is required to wear the CGM device continuously.\n\ndefined as any one of the following: After completing 2 sets, the subjects have an optional office visit to download pump and CGM data and will continue to additional two wears. At day 40 or after using 4 completed wears of infusion sets (Note: early infusion set failure with wear time of \\<6 hours due to insertion failure will be reported, yet not accounted as completed wear), the patients will return to a visit, download pump and CGM data, and end the study.\n\nif study 1 is successful, participants will enter study 2; , the same study designed will be performed on the current on-market Extended infusion set (EIS) for comparison of clinical performance with the PIS, using the same cohort of pump users', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Maya Hirsh Maya Laron Hirsh Study coordinator, M.Sc', 'role': 'CONTACT', 'email': 'maya.laronhirsh@sheba.health.gov.il', 'phone': 'Maya.Laron-hirsh@sheba.gov.il'}, {'name': 'Sapir Barel', 'role': 'CONTACT', 'email': 'Sapir.Barel@sheba.gov.il', 'phone': '0526177726'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Amir Tirosh', 'investigatorFullName': 'Prof. Amir Tirosh', 'investigatorAffiliation': 'Sheba Medical Center'}}}}