DAFNEplus Cluster Randomised Controlled Trial
Research type
Research Study
Full title
A cluster randomised controlled trial of the DAFNEplus (Dose Adjustment for Normal Eating) intervention: A lifelong approach to promote effective self-management in adults with type 1 diabetes
IRAS ID
235621
Contact name
Simon Heller
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
3 years, 10 months, 31 days
Research summary
DAFNE stands for Dose Adjustment For Normal Eating. It is a 5-day training course for adults with type 1 diabetes, delivered in small groups. DAFNE has been delivered to over 40,000 adults in the UK. Our recent research confirmed that after attending a DAFNE course, people have better quality of life, better glucose levels (in the short-term) and are admitted to hospital less often for diabetes emergencies. Although participants find DAFNE training useful, some find it tough to keep up the skills needed to maintain glucose levels to prevent diabetic complications. After the course, people also find it hard to get support from health professionals. They have asked us to improve the course to help others develop and keep their skills over the long term.
The aim of DAFNEplus is to develop and convert DAFNE into a lifelong package to help people better manage their blood glucose levels in the longer term, as high levels can cause dangerous complications. We are doing this by revising the course, putting together structured follow-up with health professionals after the course, and using technology to help people maintain the skills they need to manage their type 1 diabetes effectively.
Following a successful pilot study which piloted and refined the prototype DAFNEplus programme in three NHS diabetes centres, we will now conduct a pragmatic cluster randomised controlled trial (RCT) to compare DAFNEplus with standard DAFNE.
A cluster RCT design is required since DAFNE educators, trained in the new programme would be ‘contaminated’ if they delivered current DAFNE, so we are randomising centres rather than individuals. The trial will take place in 14 centres across the UK, and will recruit a total of 662 participants (331 will receive DAFNEplus and 331 will receive standard DAFNE).
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
18/SW/0100
Date of REC Opinion
16 May 2018
REC opinion
Further Information Favourable Opinion