Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-27 @ 7:03 AM
Study NCT ID:
NCT04915066
Status:
COMPLETED
Last Update Posted:
2021-09-22
First Post:
2021-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Insulin Pump Discontinuation in Adults With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 313}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-21', 'studyFirstSubmitDate': '2021-05-28', 'studyFirstSubmitQcDate': '2021-06-04', 'lastUpdatePostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Permanent discontinuation of insulin pump use.', 'timeFrame': 'at 18 months', 'description': 'Insulin pump discontinuation is considered permanent if \\> 6 consecutive months with patient back to insulin pen and no use of pump-related consumables during the 6 months.'}], 'secondaryOutcomes': [{'measure': 'Age', 'timeFrame': 'at day 0', 'description': 'Age of patient at the moment of insulin pump discontinuation.'}, {'measure': 'Sex', 'timeFrame': 'at day 0', 'description': 'Sex of patient'}, {'measure': 'type of diabete', 'timeFrame': 'at day 0', 'description': 'type 1 or 2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes mellitus, type 1', 'Diabetes mellitus, type 2', 'Insulin Infusion Systems', 'Patient Education'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the rate of insulin pump discontinuation 18 months after initiation in patients with diabetes, and to determine factors associated with this discontinuation.', 'detailedDescription': 'Insulin pump discontinuation has been mostly studied in children and young adults living with diabetes, and rarely with a time-to-event analysis. We aim to evaluate the rate of insulin pump discontinuation after 18 months from initiation and factors associated with it in adults with diabetes.\n\nKnowing these factors would allow better support for patients in difficulty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Sample of patients from the diabetes department of a public hospital in France (Corbeil-Essonnes).', 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients (adults and adolescents) with diabetes and an insulin pump initiation from 1 January 2015 to 30 June 2018 in the diabetes department of the Centre hospitalier sud francilien.\n\nExclusion Criteria:\n\n* Pregnant women (or women planning pregnancy in the short term) with an insulin pump initiation from 1 January 2015 to 30 June 2018\n* Patients hospitalized for an insulin pump replacement or change between 1 January 2015 and 30 June 2018.\n* Patients with a history of insulin pump initiation within a period of less than 6 months before a new pump start between 1 January 2015 and 30 June 2018.'}, 'identificationModule': {'nctId': 'NCT04915066', 'acronym': 'STOPPOMPE', 'briefTitle': 'Study of Insulin Pump Discontinuation in Adults With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Sud Francilien'}, 'officialTitle': 'Probability and Factors Associated With Early Discontinuation of Insulin Pump Therapy in Adults With Diabetes at the Center Hospitalier Sud Francilien', 'orgStudyIdInfo': {'id': '2021/0012'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Medical data collection', 'type': 'OTHER', 'description': "Collection of medical data from patients'medical records"}]}, 'contactsLocationsModule': {'locations': [{'zip': '91106', 'city': 'Corbeil-Essonnes', 'country': 'France', 'facility': 'Centre Hospitalier Sud Francilien', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Sud Francilien', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}