CGM Use in Adults With Type 2 Diabetes on Basal Insulin
NCT ID: NCT05944432
Last Updated: 2025-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
470 participants
INTERVENTIONAL
2023-07-14
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FreeStyle Libre system
FreeStyle Libre 3 continuous glucose monitoring system
FreeStyle Libre 3 Continuous Glucose Monitoring System.
Subjects will be randomised to use the FreeStyle Libre 3 system
Standard of care (control)
Self monitoring of blood glucose
Self monitoring of blood glucose
Subjects will be randomised to continue with their current glucose monitoring system
Interventions
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FreeStyle Libre 3 Continuous Glucose Monitoring System.
Subjects will be randomised to use the FreeStyle Libre 3 system
Self monitoring of blood glucose
Subjects will be randomised to continue with their current glucose monitoring system
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes diagnosis for ≥1 year prior to enrolment.
* Type 2 diabetes treated with a basal insulin injection regimen and SGLT2 inhibitor and/or GLP-1.
* Screening HbA1c ≥59 mmol/mol to ≤97 mmol/mol (≥7.5% and ≤11.0%, inclusive).
Exclusion Criteria
* Currently participating in another study that could affect glucose measurements or glucose management.
* A female participant who is pregnant.
* A breastfeeding female participant.
* Bariatric surgical procedure within the past 12 months or is planning/scheduled for bariatric surgery within the study duration.
18 Years
ALL
No
Sponsors
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Abbott Diabetes Care
INDUSTRY
Responsible Party
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Principal Investigators
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Pamela Reid
Role: STUDY_DIRECTOR
Abbott Diabetes Care Ltd
Locations
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Tameside General Hospital
Ashton-under-Lyne, , United Kingdom
Royal United Hospital
Bath, , United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Cambridge University Hospital (Addenbrookes)
Cambridge, , United Kingdom
Darlington Memorial Hospital
Darlington, , United Kingdom
Royal Derby Hospital
Derby, , United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
Princess Alexandra Hospital
Harlow, , United Kingdom
Northwick Park Hospital
Harrow, , United Kingdom
Hull Royal Infirmary
Hull, , United Kingdom
Ipswich Hospital
Ipswich, , United Kingdom
St James University Hospital
Leeds, , United Kingdom
Leicester General Hospital
Leicester, , United Kingdom
King's College Hospital
London, , United Kingdom
St Mary's Hospital
London, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Norfolk and Norwich University Hospital
Norwich, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
The Adam Practice
Poole, , United Kingdom
Queen Alexandra Hospital
Portsmouth, , United Kingdom
Northern General Hospital
Sheffield, , United Kingdom
Moorgreen Hospital
Southampton, , United Kingdom
Singleton Hospital
Swansea, , United Kingdom
Wishaw Hospital
Wishaw, , United Kingdom
Countries
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References
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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.
Other Identifiers
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ADC-UK-PMS-22057
Identifier Type: -
Identifier Source: org_study_id
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