Methods and analysis: A pragmatic cluster randomised controlled trial in adults with T1D, delivered in diabetes centres in NHS secondary care hospitals in the United Kingdom. Centres will be randomised on a 1:1 basis to standard DAFNE or DAFNEplus. Primary clinical outcome is the change in HbA1c (glycated haemoglobin) and the primary endpoint is HbA1c at 12 months, in those entering the trial with HbA1c >7.5% (58 mmol/mol), and HbA1c at 6 months is the secondary endpoint. Sample size is 662 participants (approximately 47 per centre); 92% power to detect a 0.5% difference in the primary outcome of HbA1c between treatment groups. The trial also measures rates of hypoglycaemia, psychological outcomes, an economic evaluation and process evaluation.
Ethics and dissemination: Ethics approval was granted by South West – Exeter Research Ethics Committee (REC ref: 18/SW/0100) on 14th May 2018. The results of the trial will be published in a National Institute for Health Research monograph and relevant high-impact journals.
Trial registration: ISRCTN42908016 – registered on 17th May 2018
- Physical and Mental Health
- diabetes mellitus, type 1
- self management
- patient education
- randomised controlled trial