Assessing the efficacy, safety and utility of hybrid closed-loop glucose control compared with standard insulin therapy combined with continuous glucose monitoring in young people (>=16 years) and adults with cystic fibrosis-related diabetes (CL4P-CF study): protocol for an open-label, multicentre, randomised, two-arm and single-period parallel trial.
No Thumbnail Available
Authors
Kadiyala N.
Coleman R.
Lakshman R.
Wilinska M.E.
Brennan A.
Lumb A.
Holt R.I.G.
Lau D.
Yajnik P.
Cheah Y.S.
Check for full-text access
Issue Date
2025
Type
Article
Language
Keywords
Alternative Title
Abstract
Introduction Cystic fibrosis- related diabetes (CFRD) is one of the most clinically impactful comorbidities associated with cystic fibrosis (CF). Current recommended management with insulin therapy is challenging due to variable daily insulin requirements and adds to the significant burden of self- management. This study aims to determine if hybrid closed- loop insulin delivery can improve glucose outcomes compared with standard insulin therapy with continuous glucose monitoring (CGM) in young people (≥16 years) and adults with CFRD. Methods and analysis This open- label, multicentre, randomised, two-arm, single- period parallel design study aims to randomise 114 young people (≥16 years) and adults with CFRD. Following a 2-3 weeks' run- in period, during which time participants use a masked CGM, participants with time in target glucose range (3.9-10.0 mmol/L) 10.0 mmol/L), mean glucose and HbA1c. Other secondary efficacy outcomes include glucose and insulin metrics, change in forced expiratory volume in 1 s and body mass index. Safety, utility, participant experiences and participant- reported outcome measures will also be evaluated. The trial is fuEthics and dissemination Ethics approval has been obtained from East of England-Cambridge South Research Ethics Committee. Results will be disseminated by peer- reviewed publications and conference presentations, and findings will be shared with people living with CF, healthcare providers and relevant stakeholders. Copyright © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ Group.
Description
Citation
Publisher
License
Journal
BMJ Open
Volume
15