Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-31 @ 1:06 PM
Study NCT ID:
NCT06979635
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-25
First Post:
2025-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Safety, Performance, and User Experience of the Tandem Mobi Automated Insulin Delivery System Among Young Competitive Athletes in Real-world Settings.
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': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2025-05-13', 'studyFirstSubmitQcDate': '2025-05-13', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serious Adverse Events (SAE)', 'timeFrame': 'At the end of the 12 weeks intervention period'}, {'measure': 'Diabetic Ketoacidosis (DKA) events', 'timeFrame': 'At the end of the 12 weeks intervention period'}, {'measure': 'Severe Hypoglycemia events', 'timeFrame': 'At the end of the 12 weeks intervention period'}, {'measure': 'Percentage of sensor glucose readings in the range 70 to 140 mg/dL', 'timeFrame': 'At the end of the 12 weeks intervention period'}, {'measure': 'Percentage of sensor glucose readings in the range 70 to 180 mg/dL', 'timeFrame': 'At the end of the 12 weeks intervention period'}, {'measure': 'Percentage of sensor glucose readings >180 mg/dL', 'timeFrame': 'At the end of the 12 weeks intervention period'}, {'measure': 'CGM derived indices- Mean glucose', 'timeFrame': 'At the end of the 12 weeks intervention period'}, {'measure': 'CGM derived indices: Coefficient of variation', 'timeFrame': 'At the end of the 12 weeks intervention period'}, {'measure': 'CGM derived indices: Peak glucose and change in glucose from the start of the meal to the peak (only calculated for post-meal periods)', 'timeFrame': 'At the end of the 12 weeks intervention period'}, {'measure': 'CGM derived indices: change in glucose from the start of the exercise to the nadir.', 'timeFrame': 'At the end of the 12 weeks intervention period'}], 'primaryOutcomes': [{'measure': 'Sensor glucose percentage of time in range (70-180 mg/dl)', 'timeFrame': 'At the end of the 12 weeks intervention period'}], 'secondaryOutcomes': [{'measure': 'Percentage of sensor glucose readings <54 mg/dl', 'timeFrame': 'At the end of the 12 weeks intervention period'}, {'measure': 'Percentage of sensor glucose readings >180 mg/dl', 'timeFrame': 'At the end of the 12 weeks intervention period'}, {'measure': 'Percentage of sensor glucose readings >250 mg/dl', 'timeFrame': 'At the end of the 12 weeks intervention period'}, {'measure': 'HbA1c', 'timeFrame': 'At the end of the 12 weeks intervention period'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Type 1 Diabetes', 'Competitive athletes', 'Hybrid Closed Loop System'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'A single arm, interventional study with 12 weeks study phase preceded by a 2-week run in phase, aiming to evaluate the effectiveness and applicability of the Tandem Mobi automated insulin delivery system (Tandem Mobi Pump System) for competitive youth athletes with type 1 diabetes in real-world conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes (T1D) for at least 6 months\n* 11≤Age≤18 years\n* HbA1c \\<10.0%\n* Current treatment with automated insulin delivery system (AID) or insulin pump for at least 1 month\n* Willing to switch to Tandem Mobi Pump System and Dexcom CGM for the study duration\n* Competitive-level athletes\n\nExclusion Criteria:\n\n* Concomitant disease that influences metabolic control or HbA1c interpretation\n* Individual has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)\n* Use of antidiabetic agents other than insulin\n* Two or more episodes of severe hypoglycemia (hypoglycemia requiring treatment by another person) within the previous 6 months\n* One or more episodes of ketoacidosis requiring hospitalization within 6 months prior to screening\n* Individual has a positive pregnancy screening test'}, 'identificationModule': {'nctId': 'NCT06979635', 'acronym': 'Captain MOBI', 'briefTitle': 'Assessing the Safety, Performance, and User Experience of the Tandem Mobi Automated Insulin Delivery System Among Young Competitive Athletes in Real-world Settings.', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'Assessing the Safety, Performance, and User Experience of the Tandem Mobi Automated Insulin Delivery System Among Young Competitive Athletes in Real-world Settings.', 'orgStudyIdInfo': {'id': '0800-24-RMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tandem Mobi Hybrid Closed Loop (HCL) pump', 'description': 'Tandem Mobi Hybrid Closed Loop (HCL) pump with an integrated Control-IQ algorithm (CIQ), the Dexcom G7 continuous glucose monitoring sensor (CGM ) and Tandem Mobi Mobile App', 'interventionNames': ['Device: Tandem Mobi Hybrid Closed Loop (HCL) pump']}], 'interventions': [{'name': 'Tandem Mobi Hybrid Closed Loop (HCL) pump', 'type': 'DEVICE', 'description': 'Tandem Mobi Hybrid Closed Loop (HCL) pump with an integrated Control-IQ algorithm (CIQ), the Dexcom G7 continuous glucose monitoring sensor (CGM ) and Tandem Mobi Mobile App', 'armGroupLabels': ['Tandem Mobi Hybrid Closed Loop (HCL) pump']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4920235', 'city': 'Petah Tikva', 'country': 'Israel', 'contacts': [{'name': 'Alona Hamou, MSc', 'role': 'CONTACT', 'email': 'alonah@clalit.org.il', 'phone': '972-3-9253282'}, {'name': 'Revital Nimri, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Schneider Children's Medical Center of Israel", 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'centralContacts': [{'name': 'Alona Hamou, Msc', 'role': 'CONTACT', 'email': 'alonah@clalit.org.il', 'phone': '972-545-950277'}], 'overallOfficials': [{'name': 'Marie Muller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Schneider Children's Medical Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}