DAFNEplus research study
Developing and trialling the DAFNEplus (Dose Adjustment for Normal Eating) intervention. A lifelong approach to promote effective self-management in adults with type 1 diabetes.
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About the study
The Clinical Trials Research Unit, ScHARR and the Department of Electronic and Electrical Engineering staff have been awarded a £3.4 million programme grant from the NIHR (National Institute for Health Research) Programme Grants for Applied Research.
The DAFNEplus research programme involves research groups from across the UK, and is led by Professor Simon Heller, Professor of Clinical Diabetes at the University of Sheffield and Research and Development Director at Sheffield Teaching Hospitals NHS Foundation Trust.
Aims
The aim is to re-develop and evaluate the DAFNE programme to help people with type 1 diabetes (T1D) to be supported and motivated to manage their condition as part of their everyday lives, in the longer term.
The DAFNEplus programme will see the introduction of several programmes, models and changes to the existing DAFNE programme.
This will include behaviour change techniques and a structured model of support with new technology.
Once the research has completed, the aim is to provide the full programme as a sustained model of support rather than an initial standalone course.
Methods
Following a successful pilot study, a cluster randomised controlled trial (RCT) opened to recruitment in September 2018. Our initial timescales have been extended due to restrictions imposed by the Covid-19 pandemic.
The large-scale Randomised Control Trial (RCT) plans to recruit 660 patients to assess the effectiveness and cost-effectiveness of DAFNEplus. The primary outcome is blood glucose control, as well as quality of life and relevant psychological outcomes. The RCT also includes a qualitative sub-study and assessment of intervention fidelity.
A number of multi-disciplinary workstreams, outlined below, developed the intervention before the pilot study started in March 2017.
- Workstream 1: Revising the DAFNE Curriculum (Lead: Professor Simon Heller)
- Workstream 2: Developing structured support (Leads: Dr David Hopkins; Professor Simon Heller)
- Workstream 3: Technology (Lead: Dr Jackie Elliott)
For further information regarding the programme please contact the study team: dafneplus@sheffield.ac.uk
Follow the progress of the DAFNEplus programme grant on Twitter: @dafneplus
Central study staff
| Name | Role | Organisation | Contact |
| Professor Simon Heller | Chief Investigator | Sheffield Teaching Hospitals NHS Foundation Trust / University of Sheffield | s.heller@sheffield.ac.uk |
| Elaine Scott | Study Manager | University of Sheffield | elaine.scott@sheffield.ac.uk |
| Prof Cindy Cooper | CTRU Oversight | University of Sheffield | c.l.cooper@sheffield.ac.uk |
| Jack Rose | Trials Support Officer | University of Sheffield | j.rose@sheffield.ac.uk |
| Jonathan Woodward | Research Assistant | University of Sheffield | jonathan.woodward@sheffield.ac.uk |
Sites and Principal Investigators
| Name and job title | Site |
| Dr Peter Hammond, Consultant Physician | Harrogate and District NHS Foundation Trust |
| Dr Mark Evans, Honorary Consultant Physician and Lecturer | Cambridge University Hospitals NHS Foundation Trust |
| Sarah Long, Senior Diabetes Dietitian | University College London Hospitals NHS Foundation Trust |
| Rosanne Dunkley, Specialist Community Diabetes Dietitian | Worcestershire Acute Hospitals NHS Foundation Trust |
| Dr Fiona Green, Consultant Physician | NHS Dumfries and Galloway |
| Dr Emma Wilmot, Consultant Diabetologist | Derby Teaching Hospitals NHS Foundation Trust |
| Dr Helen Hopkinson, Consultant Physician | Greater Glasgow and Clyde Health Board |
| Nardos Yemane, Senior Diabetes Specialist Dietitian | Guy's and St Thomas' NHS Foundation Trust |
| Tina Spence, Diabetes Specialist Nurse | South Tees Hospitals NHS Foundation Trust |
| Dr Tasso Gazis, Consultant in Endocrinology, Diabetes and General Medicine | Nottingham University Hospitals NHS Trust |
| Professor Thozhukat Sathyapalan, Honorary Consultant Endocrinologist | Hull University teaching Hospitals NHS Trust |
| Angela Thomas, Advanced Diabetes Specialist Nurse | Birmingham Community NHS Foundation Trust |
Co-investigators
| Name | Role | Institution |
| Dr Jackie Elliott | Senior Clinical Lecturer / Consultant Diabetologist | University of Sheffield |
| Professor Alan Brennan | Professor of Health Economics and Decision Modelling | University of Sheffield |
| Dr Mohammed Benaissa | Senior Lecturer (Electrical and Electronic Engineering) | University of Sheffield |
| Professor Julia Lawton | Professor of Health and Social Science | University of Edinburgh |
| Dr Debbie Cooke | Senior Lecturer (Health Psychology) | University of Surrey |
| Dr David Hopkins | Senior Consultant Physician, Diabetologist | King’s College Hospital NHS Foundation Trust |
| Simon Fisher | Patient Representative | DAFNE Online |
| Professor Susan Michie | Professor of Health Psychology | University College London |
| Professor Jane Speight | Professor of Behavioural and Social Research in Diabetes | Deakin University, Australia |
| Caroline Ferguson | DAFNE Educator and Diabetes Specialist Nurse | Chesterfield Royal Hospitals NHS Foundation Trust |
| Gill Thompson | National DAFNE Collaborative Manager | Northumbria Healthcare NHS Foundation Trust |
| Professor Stephanie Amiel | Professor of Diabetic Medicine | King’s College London |
| Professor Wendy Baird | Professor of Health Services Research | University of Sheffield |
| Professor Lucy Yardley | Professor of Health Psychology | University of Southampton |
DAFNEplus publications as of July 2025
- Breckenridge, J. P., Gianfrancesco, C., de Zoysa, N., Lawton, J., Rankin, D. and Coates, E. (2018) 'Mobilising knowledge between practitioners and researchers to iteratively refine a complex intervention (DAFNEplus) pre-trial: protocol for a structured collaborative working group process’, Pilot Feasibility Stud, 4, pp. 120. https://doi.org/10.1186/s40814-018-0314-4
- Campbell, F., Lawton, J., Rankin, D., Clowes, M., Coates, E., Heller, S., de Zoysa, N., Elliott, J. and Breckenridge, J. P. (2018) 'Follow-Up Support for Effective type 1 Diabetes self-management (The FUSED Model): A systematic review and meta-ethnography of the barriers, facilitators and recommendations for sustaining self-management skills after attending a structured education programme', BMC Health Serv Res, 18(1), pp. 898. doi: 10.1186/s12913-018-3655-z
- Coates, E., Amiel, S., Baird, W., Benaissa, M., Brennan, A., Campbell, M. J., Chadwick, P., Chater, T., Choudhary, P., Cooke, D., Cooper, C., Cross, E., De Zoysa, N., Eissa, M., Elliott, J., Gianfrancesco, C., Good, T., Hopkins, D., Hui, Z., Lawton, J., Lorencatto, F., Michie, S., Pollard, D. J., Rankin, D., Schutter, J., Scott, E., Speight, J., Stanton-Fay, S., Taylor, C., Thompson, G., Totton, N., Yardley, L., Zaitcev, A., Heller, S. and group, D. (2021) 'Protocol for a cluster randomised controlled trial of the DAFNE', BMJ Open, 11(1), pp. e040438. https://doi.org/10.1136/bmjopen-2020-040438
- Eissa, M. R., Good, T., Elliott, J. and Benaissa, M. (2020) 'Intelligent Data-Driven Model for Diabetes Diurnal Patterns Analysis', IEEE J Biomed Health Inform, 24(10), pp. 2984-2992.
- Hamilton, K., Stanton-Fay, S. H., Chadwick, P. M., Lorencatto, F., de Zoysa, N., Gianfrancesco, C., Taylor, C., Coates, E., Breckenridge, J. P., Cooke, D., Heller, S. R., Michie, S. and group, D. s. (2021) 'Sustained type 1 diabetes self-management: Specifying the behaviours involved and their influences', Diabet Med, 38(5), pp. e14430. https://doi.org/10.1111/dme.14430
- Heller, S. R., Gianfrancesco, C., Taylor, C. and Elliott, J. (2020) 'What are the characteristics of the best type 1 diabetes patient education programmes (from diagnosis to long-term care), do they improve outcomes and what is required to make them more effective?', Diabet Med, 37(4), pp. 545-554.
- Holmes-Truscott, E., Cooke, D. D., Hendrieckx, C., Coates, E. J., Heller, S. R. and Speight, J. (2021) 'A comparison of the acceptability and psychometric properties of scales assessing the impact of type 1 diabetes on quality of life-Results of 'YourSAY: Quality of Life'', Diabet Med. 2021 Jun;38(6):e14524. doi: 10.1111/dme.14524. Epub 2021 Feb 5. PMID: 33445223
- Stanton-Fay, S. H., Hamilton, K., Chadwick, P. M., Lorencatto, F., Gianfrancesco, C., de Zoysa, N., Coates, E., Cooke, D., McBain, H., Heller, S. R., Michie, S. and group, D. s. (2021) 'The DAFNEplus programme for sustained type 1 diabetes self-management: Intervention development using the Behaviour Change Wheel', Diabet Med, 38(5), pp. e14548. https://doi.org/10.1111/dme.14548
- Zaitcev, A., Eissa, M. R., Hui, Z., Good, T., Elliott, J. and Benaissa, M. (2020) 'A Deep Neural Network Application for Improved Prediction of HbA1c in Type 1 Diabetes', IEEE J Biomed Health Inform, 24(10), pp. 2932-2941.
- MR. Eissa, M Benaissa, T Good, Z Hui, C Gianfrancesco, C Ferguson and J Elliott. Analysis of real-world capillary blood glucose data to help reduce HbA1c and hypoglycaemia in type 1 diabetes: Evidence in favour of using the percentage of readings in target and coefficient of variation. Diabet Med. 09 Oct 2022 https://doi.org/10.1111/dme.14972
- Heller S. Handing control to the patient – structured education in diabetes. The British Journal of Diabetes Vol.22 No Supplement 1 (2022): December 2022 Supplement 1 https://doi.org/10.15277/bjd.2022.363
- Zaitcev A, Eissa MR, Hui Z, Good T, Elliott J and Benaissa M (2023) Automatic inference of hypoglycemia causes in type 1 diabetes: a feasibility study. Front. Clin. Diabetes Healthc. 4:1095859. doi: 10.3389/fcdhc.2023.1095859
- Lawton J, Chadwick PM, de Zoysa N, Stanton-Fay S, Heller SR, Rankin D; DAFNEplus Study Group. Participants' experiences of attending a structured education course (DAFNEplus) informed by behavioural science. Diabet Med. 2024 Feb 15:e15309. doi: 10.1111/dme.15309. Epub ahead of print. PMID: 38361333.
- Lawton J, Rankin D, Scott E, Lorencatto F, Gericke C, Heller SR, de Zoysa N; DAFNEplus Study Group. From educator to facilitator: Healthcare professionals' experiences of, and views about, delivering a type 1 diabetes structured education programme (DAFNEplus ) informed by behavioural science. Diabet Med. 2024 Jun 4:e15375. doi: 10.1111/dme.15375. Epub ahead of print. PMID: 38837475.
- Hart RI, Rankin D, Chadwick PM, de Zoysa N, Heller S, Cooke D, Elliott J, Lawton J; DAFNEplus study group. Sustaining the benefits of structured education: Participants' experiences of receiving structured individual support during a programme (DAFNEplus) informed by behavioural science. Diabet Med. 2024 May 31:e15371. doi: 10.1111/dme.15371. Epub ahead of print. PMID: 38820261.
- Holmes-Truscott E, Jasmine Schipp, Debbie D. Cooke, Christel Hendrieckx, Elizabeth J. Coates , Simon R. Heller and Jane Speight. Perceptions of adults with type 1 diabetes toward diabetes-specific quality of life measures: a survey-based qualitative exploration. Health and Quality of Life Outcomes (2024) 22:70 https://doi.org/10.1186/s12955-024-02285-4
- Breckenridge JP, Gossage-Worrall R, Chadwick P, De Zoysa N, Elliott J, Gianfrancesco C, Hamilton K, Heller S, Lawton J, Rankin D, Stanton-Fay S, Coates E; DAFNEplus Collaborative Working Group. The collaborative working group method for pre-trial knowledge mobilisation: a qualitative evaluation of a structured process for iteratively refining a complex intervention (DAFNEplus). Pilot Feasibility Stud. 2024 Dec 21;10(1):154. doi: 10.1186/s40814-024-01576-3. PMID: 39709454; PMCID: PMC11662412.
- de Zoysa N, Chadwick P, Ferguson C, Gianfrancesco C, Lawton J, Heller S. Training DAFNEplus facilitators in novel behaviour change approaches: A template for training design and delivery. Diabet Med. 2025 Sep;42(9):e70078. doi: 10.1111/dme.70078. Epub 2025 Jun 22.