Protocol for a cluster randomised controlled trial of the DAFNE

The successful treatment of type 1 diabetes (T1D) requires those affected to employ insulin therapy to maintain their blood glucose levels as close to normal to avoid complications in the long-term. The Dose Adjustment For Normal Eating (DAFNE) intervention is a group education course designed to help adults with T1D develop and sustain the complex self-management skills needed to adjust insulin in everyday life. It leads to improved glucose levels in the short term (manifest by falls in glycated haemoglobin, HbA1c), reduced rates of hypoglycaemia and sustained improvements in quality of life but overall glucose levels remain well above national targets. The DAFNE A pragmatic cluster randomised controlled trial in adults with T1D, delivered in diabetes centres in National Health Service secondary care hospitals in the UK. Centres will be randomised on a 1:1 basis to standard DAFNE or DAFNE Ethics approval was granted by South West-Exeter Research Ethics Committee (REC ref: 18/SW/0100) on 14 May 2018. The results of the trial will be published in a National Institute for Health Research monograph and relevant high-impact journals. ISRCTN42908016.

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Déclaration de conflit d'intérêts

Competing interests: SA reports Advisory Board membership for Novonordisk, Medtronic, Roche and Abbott. MJC reports personal fees from University of Sheffield. DJP reports non-financial support from Novo Nordisk, Eli Lilly and Company Limited, Abbott Diabetes Care, Sanofi-Aventis and Medtronic. SH reports Advisory board membership and consultancy for Sanofi-Aventis, Boeringher‐Ingelheim, Eli-Lilly, Novo‐Nordisk, Springer Medical, Zealand Pharma and UN-EEG. Personal fees for speaker panels for Novo‐Nordisk. JS reports Personal fees, non-financial support and other (advisory board membership/support to attend educational meetings) from Medtronic, Roche Diabetes Care and Sanofi Diabetes, grants and personal fees from Abbott Diabetes Care, grants and personal fees from AstraZeneca.