Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT05951569
Status:
COMPLETED
Last Update Posted:
2023-10-12
First Post:
2023-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Loop T2D Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-08-09', 'releaseDate': '2024-03-11'}], 'estimatedResultsFirstSubmitDate': '2024-03-11'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-10', 'studyFirstSubmitDate': '2023-07-11', 'studyFirstSubmitQcDate': '2023-07-11', 'lastUpdatePostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Loop T2D Baseline General Data Collection', 'timeFrame': 'Enrollment', 'description': "Self-report participant's basic information. No scale provided, variable responses."}, {'measure': 'Loop T2D Follow-up Survey', 'timeFrame': 'Monthly up to 3 months', 'description': "Self-report of participant's use of Loop and Loop related features. No scale provided, variable responses."}, {'measure': 'HbA1c', 'timeFrame': 'Enrollment, Monthly up to 3 months', 'description': 'Self-report'}], 'primaryOutcomes': [{'measure': 'Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events', 'timeFrame': 'Up to 3 months', 'description': 'Number of DKA events and event outcomes. DKA events are defined as hospitalization with documentation of arterial blood pH \\<7.30 or venous pH \\<7.24 or serum bicarbonate (or CO2) \\<15.'}, {'measure': 'Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events', 'timeFrame': 'Up to 3 months', 'description': "Number of severe hypoglycemic events and event outcomes. Severe hypoglycemia is defined as low blood sugar that affected the individual's ability to think such that they were unable to treat themselves and needed assistance from someone else. The individual may or may not have lost consciousness."}, {'measure': 'Measure of Loop Safety by Self-Report of Hospitalization Events', 'timeFrame': 'Up to 3 months', 'description': 'Number of hospitalizations'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Loop', 'Type 2 Diabetes', 'Diabetes Mellitus', 'Glucose Metabolism Disorders', 'Metabolic Diseases', 'Endocrine System Diseases', 'Autoimmune Diseases', 'Immune System Diseases'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '33226840', 'type': 'RESULT', 'citation': 'Lum JW, Bailey RJ, Barnes-Lomen V, Naranjo D, Hood KK, Lal RA, Arbiter B, Brown AS, DeSalvo DJ, Pettus J, Calhoun P, Beck RW. A Real-World Prospective Study of the Safety and Effectiveness of the Loop Open Source Automated Insulin Delivery System. Diabetes Technol Ther. 2021 May;23(5):367-375. doi: 10.1089/dia.2020.0535. Epub 2021 Apr 12.'}, {'pmid': '38386434', 'type': 'DERIVED', 'citation': 'Bauza C, Kanapka LG, Greene E, Lal RA, Arbiter B, Beck RW. Use of the Community-Derived Open-Source Automated Insulin Delivery Loop System in Type 2 Diabetes. Diabetes Technol Ther. 2024 Jul;26(7):494-497. doi: 10.1089/dia.2023.0569. Epub 2024 Apr 8.'}]}, 'descriptionModule': {'briefSummary': 'An observational study to collect data on the efficacy, safety, usability, and quality of life/psychosocial effects of the community-derived OS-AID Loop System on adults with type 2 diabetes.', 'detailedDescription': 'The study will include adults with type 2 diabetes in the United States, with a recruitment goal of a maximum of 100 participants. Data to be collected to address the study objective will include CGM metrics; HbA1c; insulin delivery data; carbohydrate data; activity data from HealthKit; self-reported adverse events (e.g., severe hypoglycemia, diabetic ketoacidosis, hospitalizations); self-reported device issues; and user experience/treatment satisfaction surveys.\n\nFollow-up data will be collected on a monthly basis as long as the study is continuing and participants are still using Loop.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with type 2 diabetes using the community-derived open-source automated insulin delivery Loop system.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* Age ≥18 years old\n* Currently using any version of Loop other than v3.0.0 or planning to start using any version of Loop other than v3.0.0 Loop within the next 30 days\n* Willing and able to provide informed consent and to complete surveys and provide the device data that are part of the protocol\n* Resident of the US\n* English speaking/reading\n* Access to email/phone\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05951569', 'briefTitle': 'Loop T2D Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Jaeb Center for Health Research'}, 'officialTitle': 'An Observational Study of Adults With Type 2 Diabetes Using the Community-Derived Open-Source Automated Insulin Delivery Loop System', 'orgStudyIdInfo': {'id': 'T2D Loop'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Community-Derived Open-Source Automated Insulin Delivery Loop System', 'type': 'DEVICE', 'description': 'The Loop System consists of an insulin pump and a Dexcom CGM. The system includes an iPhone with the Loop app and a RileyLink to communicate between the pump and iPhone. An Apple Watch may optionally be used with the system.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33647', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Jaeb Center for Health Research', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Colleen Bauza, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jaeb Center for Health Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jaeb Center for Health Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Embecta Medical', 'class': 'UNKNOWN'}, {'name': 'Tidepool Project', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-03-11', 'type': 'RELEASE'}, {'date': '2024-08-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jaeb Center for Health Research'}}}}