Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-14 @ 3:26 PM
Study NCT ID:
NCT07177404
Status:
RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Choices and Experiences Around Closed-loop Therapy in Type 1 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'}], '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': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2025-09-01', 'studyFirstSubmitQcDate': '2025-09-09', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ranking of factors influencing the choice of closed-loop therapy among people with type 1 diabetes', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'Ranking of factors contributing to treatment satisfaction with closed-loop therapy', 'timeFrame': 'Day 1'}, {'measure': 'Distribution of responses to 5-point Likert scale questions assessing factors contributing to treatment satisfaction with closed-loop therapy', 'timeFrame': 'Day 1'}, {'measure': 'Distribution of responses to 5-point Likert scale questions assessing the support needs of people using closed-loop therapy', 'timeFrame': 'Day 1'}, {'measure': 'Associations of demographics and reported glucose levels with factors influencing the choice of closed-loop therapy', 'timeFrame': 'Day 1'}, {'measure': 'Associations of demographics and reported glucose levels with factors contributing to treatment satisfaction with closed-loop therapy', 'timeFrame': 'Day 1'}, {'measure': 'Associations of demographics and reported glucose levels with support needs related to closed-loop therapy', 'timeFrame': 'Day 1'}]}, 'conditionsModule': {'keywords': ['Diabetes mellitus', 'Type 1 Diabetes Mellitus', 'Hybrid Closed Loop', 'Automated Insulin Delivery', 'Patient survey', 'Survey'], 'conditions': ['Diabete Mellitus', 'Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Type 1 diabetes requires a lot of work to try to keep glucose levels in the target range. Hybrid closed- loop, also known as artificial pancreas, takes glucose readings from a sensor (continuous glucose monitor) and uses an algorithm to tell an insulin pump how much insulin to deliver. Hybrid closed-loop has currently been rolled out to many people with type 1 diabetes in England. We are keen to develop a deeper understanding of the perspective of people living with type 1 diabetes who have choices about which hybrid closed-loop systems fit their needs.\n\nThe main purpose of this study is to explore the choices and experiences of people living with type 1 diabetes regarding closed-loop therapy.', 'detailedDescription': 'This is a cross-sectional online survey study, which involves people with type 1 diabetes who use closed-loop, wait to start closed-loop or considering closed-loop.\n\nThe primary objective of the study is to explore the factors driving the choices of people living with type 1 diabetes regarding closed-loop therapy.\n\nThe secondary objectives of the study are:\n\n* To understand what treatment satisfaction with closed-loop therapy means to people living with type 1 diabetes\n* To understand what additional support is needed for people with type 1 diabetes using closed-loop therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be approached via their usual University Hospitals of Derby \\& Burton NHS diabetes care team.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: ≥18 years (no upper age limit)\n* Type 1 diabetes (any duration)\n* People who use closed-loop therapy or wait to start closed-loop therapy or considering closed-loop therapy in the future\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* Any other type of diabetes apart from type 1 diabetes'}, 'identificationModule': {'nctId': 'NCT07177404', 'acronym': 'SELECT HCL', 'briefTitle': 'Choices and Experiences Around Closed-loop Therapy in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Nottingham'}, 'officialTitle': 'Surveying Experiences and Lifestyle Effects in Choosing Technology and Hybrid Closed Loop in Type 1 Diabetes', 'orgStudyIdInfo': {'id': '25026'}}, 'contactsLocationsModule': {'locations': [{'city': 'Derby', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Alexandros Liarakos', 'role': 'CONTACT', 'email': 'alexandros.liarakos1@nhs.net', 'phone': '0044 1332 258268'}], 'facility': 'University Hospitals of Derby and Burton', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}], 'centralContacts': [{'name': 'Emma Wilmot', 'role': 'CONTACT', 'email': 'emma.wilmot@nottingham.ac.uk', 'phone': '0044 1332 258268'}, {'name': 'Alexandros Liarakos', 'role': 'CONTACT', 'email': 'alexandros.liarakos1@nhs.net'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nottingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}