Wilmot, E.G., Ajjan, R.A., Cheah, Y.S. orcid.org/0009-0009-1948-1960 et al. (17 more authors) (2025) 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, 15 (4). e090154. ISSN 2044-6055
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.
Trial registration number: NCT05944432.
Secondary identifying number: Identifier assigned by the sponsor: ADC-UK-PMS-22057.
Protocol version: Revision D. Dated, 13 December 2024.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
Keywords: | Humans; Diabetes Mellitus, Type 2; Insulin; Blood Glucose; Hypoglycemic Agents; Blood Glucose Self-Monitoring; Female; Male; Glucagon-Like Peptide 1; Multicenter Studies as Topic; Randomized Controlled Trials as Topic; United Kingdom; Sodium-Glucose Transporter 2 Inhibitors; Glycemic Control; Glycated Hemoglobin |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Medicine and Population Health |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 09 May 2025 11:10 |
Last Modified: | 09 May 2025 11:10 |
Status: | Published |
Publisher: | BMJ |
Refereed: | Yes |
Identification Number: | 10.1136/bmjopen-2024-090154 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:226139 |