Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-25 @ 5:35 PM
Study NCT ID:
NCT06294704
Status:
COMPLETED
Last Update Posted:
2025-08-17
First Post:
2024-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hybrid Closed Loop Insulin Pump and Bariatric Surgery in Patients With Type 1 Diabetes
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050110', 'term': 'Bariatric Surgery'}], 'ancestors': [{'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2024-02-28', 'studyFirstSubmitQcDate': '2024-02-28', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time spent within glycemic target 70-180 mg/dL', 'timeFrame': 'at 3 months', 'description': 'time spent within glycemic target 70-180 mg/dL in type 1 diabetes patients who underwent bariatric surgery,'}], 'secondaryOutcomes': [{'measure': 'Time spent in level 1 hyperglycemia (181-250 mg/dL)', 'timeFrame': 'at 3 months', 'description': 'Time spent in level 1 hyperglycemia (181-250 mg/dL)\n\nTime spent in level 1 hyperglycemia (181-250 mg/dL)\n\nTime spent in level 1 hyperglycemia (181-250 mg/dL)'}, {'measure': 'Time spent in level 2 hyperglycemia (>250 mg/dL)', 'timeFrame': 'at 3 months', 'description': 'Time spent in level 2 hyperglycemia (\\>250 mg/dL)'}, {'measure': 'HbA1c', 'timeFrame': 'at 3 months', 'description': 'HbA1c'}, {'measure': 'Coefficient of variation', 'timeFrame': 'at 3 months', 'description': 'Coefficient of variation'}, {'measure': 'Time spent in level 1 hypoglycemia (51-70 mg/dl)', 'timeFrame': 'at 3 months', 'description': 'Time spent in level 1 hypoglycemia (51-70 mg/dl)'}, {'measure': 'Time spent in level 2 hypoglycemia (< 50 mg/gdl)', 'timeFrame': 'at 3 months', 'description': 'Time spent in level 2 hypoglycemia (\\< 50 mg/gdl)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bariatric surgery', 'type 1 diabetes', 'hybrid closed-loop insulin pump'], 'conditions': ['Bariatric Surgery', 'Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'Bariatric surgery is increasingly performed on patients with type 1 diabetes. It exposes these patients to an increased risk of hypoglycemia, including severe hypoglycemia, and of severe episodes of hyperglycemia, beyond the perioperative period. The long-term efficacy and safety of hybrid closed-loop insulin pump in these patients has not yet been published.', 'detailedDescription': 'Patients with type 1 diabetes and obesity are at risk of "double diabetes". Bariatric surgery may be indicated for these patients, to combat insulin resistance. Nevertheless, post-operative patients are at risk of hypoglycemia.\n\nAt the same time, patients with type 1 diabetes can benefit from a hybrid closed loop insulin pump to improve diabetes control and reduce the occurrence of hypoglycemia.\n\nIn type 1 diabetic patients who have undergone bariatric surgery and are treated with a hybrid closed loop insulin pump, continuous glucose measurement can be studied. In the medium and long term, the efficacy and safety of this system in this context will be described.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with type 1 diabetes who underwent bariatric surgery and treated by hybrid closed-loop insulin pump.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major patient\n* With type 1 diabetes for \\> 1 year\n* Obese (BMI≥30)\n* Having undergone bariatric surgery\n* On a hybrid closed-loop insulin pump\n* Not pregnant\n* No hybrid closed-loop insulin pump discontinuation for more than 45 days after surgery\n\nExclusion Criteria:\n\n\\- Patient informed and opposed to data use'}, 'identificationModule': {'nctId': 'NCT06294704', 'acronym': 'PompBariatDT1', 'briefTitle': 'Hybrid Closed Loop Insulin Pump and Bariatric Surgery in Patients With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Sud Francilien'}, 'officialTitle': 'Hybrid Closed Loop Insulin Pump and Bariatric Surgery in Patients With Type 1 Diabetes', 'orgStudyIdInfo': {'id': '2024/0004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'bariatric surgery', 'type': 'OTHER', 'otherNames': ['Hybrid closed-loop insulin pump'], 'description': 'Having undergone bariatric surgery and on a closed-loop insulin pump after bariatric surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91106', 'city': 'Corbeil-Essonnes', 'state': 'France', 'country': 'France', 'facility': 'Centre Hospitalier Sud Francilien', 'geoPoint': {'lat': 48.60603, 'lon': 2.48757}}, {'zip': '44000', 'city': 'Nantes', 'state': 'France', 'country': 'France', 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75013', 'city': 'Paris', 'state': 'France', 'country': 'France', 'facility': 'APHP Hôpital de la Pitié Salpètrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Geoffrey BOULATE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Sud Francilien'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Sud Francilien', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}