Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-11 @ 2:20 PM
Study NCT ID:
NCT05944432
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-08
First Post:
2023-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CGM Use in Adults With Type 2 Diabetes on Basal Insulin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015190', 'term': 'Blood Glucose Self-Monitoring'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D000085263', 'term': 'Self-Testing'}, {'id': 'D012648', 'term': 'Self Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 470}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2023-07-06', 'studyFirstSubmitQcDate': '2023-07-12', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '16 weeks', 'description': 'Difference between treatment groups in mean change from baseline in HbA1c.'}], 'secondaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '32 weeks', 'description': 'Difference between treatment groups in mean change from baseline in HbA1c'}, {'measure': 'Time in range (TIR)', 'timeFrame': '32 weeks', 'description': 'Time spent in glucose target range (TIR) 3.9 to 10.0 mmol/L (70 to 180 mg/dL).'}, {'measure': 'Time above range (TAR)', 'timeFrame': '32 weeks', 'description': 'Time spent above glucose target range (TAR) \\>10.0 mmol/L, 13.9 mmol/L and 16.7 mmol/L (\\>180 mg/dL, \\>250 mg/dL and \\>300 mg/dL).'}, {'measure': 'Time below range(TBR)', 'timeFrame': '32 weeks', 'description': 'Time spent below glucose target range (TBR) \\<3.9 mmol/L and \\<3.0 mmol/L (\\<70 mg/dL and \\<54 mg/dL).'}, {'measure': 'Frequency of hypoglycaemia events', 'timeFrame': '32 weeks', 'description': 'CGM detected hypoglycaemia events defined as ≥15 minutes duration with glucose \\<3.9 mmol/L (\\<70 mg/dL).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '40233956', 'type': 'DERIVED', 'citation': 'Wilmot EG, Ajjan RA, Cheah YS, Choudhary P, Cranston I, Elliott RA, Evans M, Iqbal A, Kamaruddin S, Barnard-Kelly K, Lumb A, Min T, Moore P, Narendran P, Neupane S, Rayman G, Sathyapalan T, Thabit H, Yates T, Leelarathna L. Impact of real-time glucose monitoring using FreeStyle Libre 3 on glycaemia in type 2 diabetes managed with basal insulin plus SGLT2 inhibitor and/or GLP-1 agonist: the FreeDM2 randomised controlled trial protocol. BMJ Open. 2025 Apr 15;15(4):e090154. doi: 10.1136/bmjopen-2024-090154.'}]}, 'descriptionModule': {'briefSummary': 'A prospective multi-centre, open-label, two arm, parallel design, superiority, pragmatic, randomised controlled trial, over an 8-month period. The purpose of this study is to determine whether continuous glucose monitoring using FreeStyle Libre 3 will improve HbA1c compared to SMBG over 16 weeks in adults with sub-optimally controlled (HbA1c 7.5-11%) Type 2 diabetes on basal therapy.', 'detailedDescription': 'The study will assess change in HbA1c as the primary endpoint. Other endpoints related to glycaemic control are included in the analyses. The study is split into two phases each of four months duration: participant-driven (phase 1) and HCP/therapy-driven (phase 2). Participants will be randomised to either FreeStyle Libre 3 or to continuation with their current SMBG device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or over.\n* Type 2 diabetes diagnosis for ≥1 year prior to enrolment.\n* Type 2 diabetes treated with a basal insulin injection regimen and SGLT2 inhibitor and/or GLP-1.\n* Screening HbA1c ≥59 mmol/mol to ≤97 mmol/mol (≥7.5% and ≤11.0%, inclusive).\n\nExclusion Criteria:\n\n* Participant is currently prescribed prandial or pre-mixed (biphasic) insulin at enrolment.\n* Currently participating in another study that could affect glucose measurements or glucose management.\n* A female participant who is pregnant.\n* A breastfeeding female participant.\n* Bariatric surgical procedure within the past 12 months or is planning/scheduled for bariatric surgery within the study duration.'}, 'identificationModule': {'nctId': 'NCT05944432', 'briefTitle': 'CGM Use in Adults With Type 2 Diabetes on Basal Insulin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Diabetes Care'}, 'officialTitle': 'Real-Time Glucose Monitoring Using FreeStyle Libre 3 in Adults With Type 2 Diabetes On Basal Insulin Plus SGLT2 Inhibitor and/or GLP-1', 'orgStudyIdInfo': {'id': 'ADC-UK-PMS-22057'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FreeStyle Libre system', 'description': 'FreeStyle Libre 3 continuous glucose monitoring system', 'interventionNames': ['Device: FreeStyle Libre 3 Continuous Glucose Monitoring System.']}, {'type': 'OTHER', 'label': 'Standard of care (control)', 'description': 'Self monitoring of blood glucose', 'interventionNames': ['Device: Self monitoring of blood glucose']}], 'interventions': [{'name': 'FreeStyle Libre 3 Continuous Glucose Monitoring System.', 'type': 'DEVICE', 'description': 'Subjects will be randomised to use the FreeStyle Libre 3 system', 'armGroupLabels': ['FreeStyle Libre system']}, {'name': 'Self monitoring of blood glucose', 'type': 'DEVICE', 'description': 'Subjects will be randomised to continue with their current glucose monitoring system', 'armGroupLabels': ['Standard of care (control)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ashton-under-Lyne', 'country': 'United Kingdom', 'facility': 'Tameside General Hospital', 'geoPoint': {'lat': 53.48876, 'lon': -2.0989}}, {'city': 'Bath', 'country': 'United Kingdom', 'facility': 'Royal United Hospital', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Cambridge University Hospital (Addenbrookes)', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Darlington', 'country': 'United Kingdom', 'facility': 'Darlington Memorial Hospital', 'geoPoint': {'lat': 54.52429, 'lon': -1.55039}}, {'zip': 'DE22 3NE', 'city': 'Derby', 'country': 'United Kingdom', 'facility': 'Royal Derby Hospital', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}, {'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'Ninewells Hospital', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'city': 'Harlow', 'country': 'United Kingdom', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': 51.77655, 'lon': 0.11158}}, {'city': 'Harrow', 'country': 'United Kingdom', 'facility': 'Northwick Park Hospital', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}, {'city': 'Hull', 'country': 'United Kingdom', 'facility': 'Hull Royal Infirmary', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'city': 'Ipswich', 'country': 'United Kingdom', 'facility': 'Ipswich Hospital', 'geoPoint': {'lat': 52.05917, 'lon': 1.15545}}, {'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'St James University Hospital', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Leicester General Hospital', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "St Mary's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9WU', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Royal Infirmary', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Norwich', 'country': 'United Kingdom', 'facility': 'Norfolk and Norwich University Hospital', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}, {'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Churchill Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Derriford Hospital', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'city': 'Poole', 'country': 'United Kingdom', 'facility': 'The Adam Practice', 'geoPoint': {'lat': 50.71429, 'lon': -1.98458}}, {'city': 'Portsmouth', 'country': 'United Kingdom', 'facility': 'Queen Alexandra Hospital', 'geoPoint': {'lat': 50.79899, 'lon': -1.09125}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Northern General Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Moorgreen Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'city': 'Swansea', 'country': 'United Kingdom', 'facility': 'Singleton Hospital', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}, {'city': 'Wishaw', 'country': 'United Kingdom', 'facility': 'Wishaw Hospital', 'geoPoint': {'lat': 55.76667, 'lon': -3.91667}}], 'overallOfficials': [{'name': 'Pamela Reid', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Diabetes Care Ltd'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Beginning 9 months and ending 3 years (36 months) following article publication', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in the primary study manuscript after deidentification (text, tables, figures and appendices) for the purposes of individual participant data meta-analysis.', 'accessCriteria': 'Researchers undertaking individual participant data meta-analysis who provide a methodologically sound proposal, approved by an independent review committee, and not overlapping with any planned secondary publications from the research team. Proposals should be directed to the corresponding author of the article who will discuss such requests with the study investigator team. To gain access, data requesters will need to sign a data access agreement. Data will be available for up to 3 years (36 months) following article publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Diabetes Care', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}