BMJ Open (Jan 2021)

Protocol for a cluster randomised controlled trial of the DAFNEplus (Dose Adjustment For Normal Eating) intervention compared with 5x1 DAFNE: a lifelong approach to promote effective self-management in adults with type 1 diabetes

  • ,
  • Debbie Cooke,
  • Lucy Yardley,
  • Jackie Elliott,
  • Cindy Cooper,
  • Tim Chater,
  • Elizabeth Coates,
  • Susan Michie,
  • Nikki Totton,
  • Alan Brennan,
  • Fabiana Lorencatto,
  • Pratik Choudhary,
  • Nicole De Zoysa,
  • Simon Heller,
  • Paul Chadwick,
  • David Hopkins,
  • Wendy Baird,
  • Jane Speight,
  • Julia Lawton,
  • José Schutter,
  • Daniel John Pollard,
  • Stephanie Amiel,
  • Carla Gianfrancesco,
  • Carolin Taylor,
  • David Rankin,
  • Gill Thompson,
  • Elaine Scott,
  • Liz Cross,
  • Michael Joseph Campbell,
  • Elizabeth Cross,
  • Mohammed Benaissa,
  • Mohammad Eissa,
  • Tim Good,
  • Zheng Hui,
  • Stephanie Stanton-Fay,
  • Gillian Thompson,
  • Aleksandr Zaitcev,
  • Becky Brown,
  • Dan Pollard,
  • Chris Turtle,
  • Nicole de Zoysa

DOI
https://doi.org/10.1136/bmjopen-2020-040438
Journal volume & issue
Vol. 11, no. 1

Abstract

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Introduction 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 DAFNEplus intervention is a development of DAFNE designed to incorporate behavioural change techniques, technology and longer-term structured support from healthcare professionals (HCPs).Methods and analysis 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 DAFNEplus. Primary clinical outcome is the change in HbA1c 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 14 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 number ISRCTN42908016.