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
Wilmot, Emma G Ajjan, Ramzi A Cheah, Yee S Choudhary, Pratik Cranston, Iain Elliott, Rachel Ann Evans, Mark Iqbal, Ahmed Kamaruddin, Shafie Barnard-Kelly, Katharine
Wilmot, Emma G
Ajjan, Ramzi A
Cheah, Yee S
Choudhary, Pratik
Cranston, Iain
Elliott, Rachel Ann
Evans, Mark
Iqbal, Ahmed
Kamaruddin, Shafie
Barnard-Kelly, Katharine
Affiliation
University of Nottingham; University Hospitals of Derby and Burton NHS Foundation Trust; University of Leeds; Leeds Teaching Hospitals NHS Trust; King's College Hospital NHS Foundation Trust; University Hospitals of Leicester NHS Trust; Portsmouth Hospitals University NHS Trust; University of Manchester; University of Cambridge; Sheffield Teaching Hospitals NHS Foundation Trust; University of Sheffield; County Durham and Darlington NHS Foundation Trust; Barnard Health; Oxford University Hospitals NHS Foundation Trust; NIHR Oxford Biomedical Research Centre; Swansea Bay University Health Board; The Adam Practice; University Hospitals Birmingham NHS Foundation Trust; Norfolk and Norwich University Hospitals NHS Foundation Trust; University of East Anglia Norwich Medical School; East Suffolk and North Essex NHS Foundation Trust; Hull University Teaching Hospitals NHS Trust; Hull York Medical School; University of Leicester; Manchester University NHS Foundation Trust; Imperial College London; Imperial College London Healthcare NHS Trust
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Publication date
2025-04-15
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Collections
Research Projects
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Journal Issue
Abstract
Introduction: Effective management of type 2 diabetes mellitus (T2DM) consists of lifestyle modification and therapy optimisation. While glycaemic monitoring can be used as a tool to guide these changes, this can be challenging with self-monitoring of blood glucose (SMBG). The FreeStyle Libre 3 (FSL3) is a real-time continuous glucose monitoring (CGM) system designed to replace SMBG. The evidence for the benefit of CGM in people with T2DM on non-intensive insulin regimens is limited. This study aims primarily to assess the glycaemic impact of FSL3 in people with suboptimally controlled T2DM treated with basal-only insulin regimens plus sodium-glucose cotransporter-2 (SGLT-2) inhibitor and/or glucagon-like peptide (GLP)-1 agonist.
Methods and analysis: This is an open-label, multicentre, parallel design, randomised (2:1) controlled trial. Recruitment has been offered across 24 clinical centres in the UK and nationally through self-referral. Adults with T2DM treated with basal-only insulin regimens plus SGLT-2 inhibitor and/or GLP-1 agonist and with screening HbA1c from ≥59 mmol/mol to ≤97 mmol/mol are included. Eligible participants will be randomised to either FSL3 (intervention) for 32 weeks or continuation of SMBG (control). The study is split into two phases, each of 16 weeks duration: phase 1 consisting of self-management with basal-insulin self-titration and phase 2 where additional therapies may be initiated. Control group participants may subsequently enter an optional extension phase to receive FSL3. The primary endpoint is the difference between treatment groups in mean change from baseline in HbA1c at 16 weeks. Secondary outcomes include HbA1c at 32 weeks, CGM-based metrics, therapy changes, physical activity levels and psychosocial measures. An economic evaluation for costs and patient outcomes will be undertaken.
Ethics and dissemination: The study was approved by the Health Research Authority, Health and Care Research Wales and the West Midlands-Edgbaston Research Ethics Committee (reference: 23/WM/0092). Study results will be disseminated in peer-reviewed journals.
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.
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Article