Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-01 @ 6:02 AM
Study NCT ID:
NCT03819634
Status:
COMPLETED
Last Update Posted:
2021-05-25
First Post:
2019-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Longevity of Multi-Slitted Catheter With Lantern Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'buckingham@stanford.edu', 'phone': '6508040476', 'title': 'Bruce Buckingham', 'organization': 'Stanford'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '10 days', 'eventGroups': [{'id': 'EG000', 'title': 'Lantern Infusion Set', 'description': 'Multi-slitted lantern infusion set\n\nInset II with Lantern Technology: Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 12, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'subcutaneous infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hyperglycemia', 'notes': 'hyperglycemia unresponsive to a correction dose of insulin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ketotosis', 'notes': 'ketosis with hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'adhesive failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Infusion Set Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lantern Infusion Set', 'description': 'Multi-slitted lantern infusion set\n\nInset II with Lantern Technology: Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'spread': '2.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 days of infusion set wear', 'description': 'Time to when the infusion set fails and needs to be replaced.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the protocol are included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lantern Infusion Set', 'description': 'Multi-slitted lantern infusion set\n\nInset II with Lantern Technology: Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lantern Infusion Set', 'description': 'Multi-slitted lantern infusion set\n\nInset II with Lantern Technology: Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.1', 'spread': '14.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes Duration', 'classes': [{'categories': [{'measurements': [{'value': '26.4', 'spread': '12.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '0.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '% glcosylated HBG:total HBG', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Daily Insulin Dose (Units)', 'classes': [{'categories': [{'measurements': [{'value': '48.0', 'spread': '16.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'spread': '4.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Participants who completed the protocol are included in the analysis for baseline characteristics.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-21', 'size': 657504, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-03T14:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'To determine length of infusion set wear for up to a maximum of 10 days'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-03', 'studyFirstSubmitDate': '2019-01-24', 'resultsFirstSubmitDate': '2021-05-03', 'studyFirstSubmitQcDate': '2019-01-25', 'lastUpdatePostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-03', 'studyFirstPostDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Infusion Set Failure', 'timeFrame': '10 days of infusion set wear', 'description': 'Time to when the infusion set fails and needs to be replaced.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Insulin Dependent Diabetes Mellitus 1']}, 'referencesModule': {'references': [{'pmid': '33822472', 'type': 'RESULT', 'citation': 'Lal RA, Hsu L, Zhang J, Schondorff PK, Heschel M, Buckingham B. Longevity of the novel ConvaTec infusion set with Lantern technology. Diabetes Obes Metab. 2021 Aug;23(8):1973-1977. doi: 10.1111/dom.14395. Epub 2021 Apr 18.'}]}, 'descriptionModule': {'briefSummary': 'To determine time to set failure when the Convatec Inset II with Lantern technology (Convatec Lantern) infusion set with multi-slitted catheter is worn for up to 10 days', 'detailedDescription': 'This is a pilot study to obtain preliminary data to determine the time to set failure when the Lantern infusion set is worn for up to 10 days. The study is not intended for registration purposes or to support a 510(k) submission. The study will be conducted at one site: Stanford University.\n\nThis study will enroll 24 subjects (as per FDA approval) to establish the maximum length of Lantern infusion set wear when 80% of sets are still functional (excluding accidental "pull-outs"). Each participant will place the set and wear it for 10 days or until set failure and data will be collected on the cause of set failure. If a set is accidentally pulled out, it can be replaced by the subject. Failures are based on:\n\n1. Presence of serum ketones with hyperglycemia\n2. Unexplained hyperglycemia\n3. Signs of infection at the infusion site\n4. Pump occlusion alarm\n5. Adhesive failure\n\nSince infusion set failures will occur after variable lengths of wear, regularly scheduled visits are unlikely to capture the day of an infusion set failure. Instead the subject will be taught how to insert the set, measure erythema and induration with a ruler marked in millimeters and to take a picture of the infusion site. Subjects will be instructed to text the study team when they remove their infusion set and to send a picture of the infusion site and measurements. If there is any evidence of an infection (≥10 mm of erythema or induration), they will be asked to come in that day for an unscheduled visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nType 1 Diabetes by clinical definition\n\n1. Age 22 and over\n2. On tethered insulin pump therapy for at least 3 months using Lispro or Aspart insulin.\n3. Hemoglobin A1c level less than or equal to 9%\n4. Eating more than 60 grams of carbohydrate each day\n5. For females, not currently known to be pregnant\n6. Understanding and willingness to follow the protocol and sign informed consent\n7. Willingness to wear the experimental infusion sets\n8. Willingness to have photographs taken of their infusion sites\n9. Ability to speak, read and write in the language of the investigators\n\nExclusion Criteria:\n\nThe presence of any of the following is an exclusion for the study:\n\n1. Diabetic ketoacidosis in the past 3 months\n2. Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment\n3. Pregnant or lactating\n4. Known tape allergies\n5. Active infection\n6. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol\n7. Known cardiovascular events in the last 6 months\n8. Known acute proliferative diabetic retinopathy\n9. Known adrenal disorder\n10. Current treatment for a seizure disorder\n11. Inpatient psychiatric treatment in the past 6 months\n12. Lack of stability on medication 1 month prior to enrollment including antihypertensive, thyroid, anti-depressant or lipid lowering medication.\n13. Use of SGLT inhibitor\n14. Suspected drug or alcohol abuse\n15. Dialysis or end stage kidney disease\n\nNote: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.'}, 'identificationModule': {'nctId': 'NCT03819634', 'acronym': 'Lantern', 'briefTitle': 'Longevity of Multi-Slitted Catheter With Lantern Technology', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Longevity of Multi-Slitted Catheter, the Convatec Inset II With Lantern Technology', 'orgStudyIdInfo': {'id': 'IRB #45812'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lantern infusion set', 'description': 'Multi-slitted lantern infusion set', 'interventionNames': ['Device: Inset II with Lantern Technology']}], 'interventions': [{'name': 'Inset II with Lantern Technology', 'type': 'DEVICE', 'description': 'Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump.', 'armGroupLabels': ['Lantern infusion set']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Bruce A Buckingham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'ConvaTec Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatric Endocrinology', 'investigatorFullName': 'Bruce Buckingham', 'investigatorAffiliation': 'Stanford University'}}}}