Additional information

CRediT contribution statement

Simon Heller (https://orcid.org/0000-0002-2425-9565): Conceptualisation (lead), Funding acquisition (lead), Methodology, Project administration, Supervision, Writing – original draft, Writing – reviewing and editing.

Elaine Scott (https://orcid.org/0000-0002-0736-649X): Funding acquisition, Investigation, Project administration, Supervision, Writing – original draft.

Jackie Elliott (https://orcid.org/0000-0002-7867-9987): Conceptualisation, Funding acquisition, Methodology, Supervision, Writing – reviewing and editing.

Esther Herbert (https://orcid.org/0000-0002-1224-5457): Data curation, Formal analysis, Validation, Visualisation, Writing – original draft, Writing – reviewing and editing.

Ines Rombach (https://orcid.org/0000-0003-3464-3867): Data curation, Formal analysis, Validation, Visualisation, Writing – original draft, Writing – reviewing and editing.

Cindy Cooper (https://orcid.org/0000-0002-2995-5447): Conceptualisation, Funding acquisition, Methodology, Project administration, Supervision, Writing – reviewing and editing.

Alan Brennan (https://orcid.org/0000-0002-1025-312X): Conceptualisation, Formal analysis, Funding acquisition, Investigation, Methodology, Software, Supervision, Visualisation, Writing – original draft, Writing – reviewing and editing.

Dan Pollard (https://orcid.org/0000-0001-5630-0115): Formal analysis, Investigation, Methodology, Software, Visualisation, Writing – original draft, Writing – reviewing and editing.

Julia Lawton (https://orcid.org/0000-0002-8016-7374): Conceptualisation, Formal analysis, Funding acquisition, Investigation, Methodology, Supervision, Visualisation, Writing – original draft, Writing – reviewing and editing.

David Rankin (https://orcid.org/0000-0002-5835-3402): Data curation, Formal analysis, Investigation, Visualisation, Writing – original draft, Writing – reviewing and editing.

Fabiana Lorencatto (https://orcid.org/0000-0003-4418-7957): Conceptualisation, Formal analysis, Funding acquisition, Investigation, Methodology, Supervision, Validation, Visualisation, Writing – original draft, Writing – reviewing and editing.

Nicole de Zoysa (https://orcid.org/0000-0003-0895-2666): Conceptualisation, Funding acquisition, Methodology, Resources, Writing – original draft, Writing – reviewing and editing.

Jane Speight (https://orcid.org/0000-0002-1204-6896): Conceptualisation, Formal analysis, Funding acquisition, Investigation, Methodology, Supervision, Visualisation, Writing –reviewing and editing.

Mohammed Benaissa (https://orcid.org/0000-0001-7524-9116): Conceptualisation, Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Resources, Software.

Mohammad Eissa (https://orcid.org/0000-0002-5584-5815): Data curation, Formal analysis, Investigation, Resources, Software.

Tim Good (https://orcid.org/0000-0001-7495-9757): Data curation, Formal analysis, Investigation, Resources, Software.

Elizabeth Holmes-Truscott (https://orcid.org/0000-0001-9139-4663): Formal analysis, Investigation, Visualisation, Writing – original draft, Writing – reviewing and editing.

Uffe Soholm (https://orcid.org/0000-0003-0848-9421): Formal analysis, Visualisation, Writing – original draft, Writing – reviewing and editing.

Debbie Cooke (https://orcid.org/0009-0005-5648-1055): Conceptualisation, Formal analysis, Funding acquisition, Methodology, Writing –reviewing and editing.

Sharmala Thuraisingam (https://orcid.org/0000-0002-9450-1302): Formal analysis.

Paul Chadwick (https://orcid.org/0000-0002-7101-5993): Methodology, Resources, Writing – reviewing and editing.

Susan Michie (https://orcid.org/0000-0003-0063-6378): Conceptualisation, Funding acquisition, Methodology, Supervision, Validation, Writing – reviewing and editing.

Stephanie Amiel (https://orcid.org/0000-0003-2686-5531): Conceptualisation, Funding acquisition, Methodology, Supervision, Writing – reviewing and editing.

David Hopkins (https://orcid.org/0000-0002-0451-0900): Conceptualisation, Funding acquisition, Methodology, Supervision, Writing – reviewing and editing.

Carolin Ferguson: Conceptualisation, Funding acquisition, Resources.

Carla Gianfrancesco (https://orcid.org/0000-0001-5966-8871): Conceptualisation, Funding acquisition, Resources, Writing – reviewing and editing.

Elizabeth Coates (https://orcid.org/0000-0002-2388-6102): Formal analysis, Investigation, Project administration, Supervision.

Elizabeth Cross (https://orcid.org/0000-0002-7976-8463): Funding acquisition, Investigation, Project administration, Supervision.

Jonathan Woodward (https://orcid.org/0000-0001-7495-1632): Investigation, Project administration, Writing – reviewing and editing.

Jose Schutter (https://orcid.org/0000-0001-7523-0538): Investigation, Project administration.

Dan Beever (https://orcid.org/0000-0001-9063-3677): Investigation, Project administration, Writing – reviewing and editing.

Dana Marbu (https://orcid.org/0009-0005-2154-2911): Investigation, Project administration, Writing – reviewing and editing.

Katie Ridsdale (https://orcid.org/0000-0002-5036-9610): Investigation, Project administration.

Amanda Loban (https://orcid.org/0000-0001-7089-1580): Data curation, Software, Validation.

Chris Turtle (https://orcid.org/0000-0003-3109-425X): Data curation, Software, Validation.

Fiona Campbell (https://orcid.org/0000-0002-4141-8863): Formal analysis, Investigation.

Yuxiao Sun (https://orcid.org/0009-0007-9862-0038): Formal analysis.

Stephanie Stanton-Fay (https://orcid.org/0000-0001-5003-8072): Formal analysis, Validation, Visualisation, Investigation.

Kathryn Hamilton: Formal analysis, Validation, Visualisation, Investigation.

Jenna Breckenridge (https://orcid.org/0000-0002-5170-7626): Formal analysis, Investigation.

Ruth Hart (https://orcid.org/0000-0003-2129-9163): Formal analysis.

Gemma Hackney (https://orcid.org/0000-0002-7084-620X): Investigation, Project administration.

Lucy Yardley (https://orcid.org/0000-0002-3853-883X): Conceptualisation, Formal analysis, Funding acquisition, Investigation, Methodology.

Zheng Hui (https://orcid.org/0000-0001-6194-4564): Data curation, Formal analysis, Software.

Pratik Choudhary (https://orcid.org/0000-0001-7635-4735): Supervision.

Wendy Baird (https://orcid.org/0000-0002-4253-2721): Conceptualisation, Funding acquisition, Methodology.

Chiara Gericke (https://orcid.org/0000-0001-7389-2036): Formal analysis, Visualisation.

Louise Holland (https://orcid.org/0009-0005-3852-3792): Conceptualisation, Supervision.

Other contributions

Simon Heller (https://orcid.org/0000-0002-2425-9565): Development of resources.

Jackie Elliott (https://orcid.org/0000-0002-7867-9987): Development of resources.

Acknowledgements

We thank those with diabetes who participated in the trial and members of the trial steering committee for their contribution. The research governance sponsor was Sheffield Teaching Hospitals NHS Foundation Trust. The clinical sites taking part were: Cambridge University Hospitals NHS Foundation Trust, Dumfries and Galloway Royal Infirmary, NHS Greater Glasgow and Clyde, King’s College Hospital NHS Foundation Trust, Nottingham University Hospitals NHS Trust, and Sheffield Teaching Hospitals NHS Foundation Trust, Harrogate & District NHS Foundation Trust, Hull University Teaching Hospitals NHS Trust, South Tees Hospitals NHS Foundation Trust, University Hospitals of Derby and Burton NHS Foundation Trust, Worcestershire Acute Hospitals NHS Foundation Trust, University College London Hospitals NHS Foundation Trust, Birmingham Community Healthcare NHS Foundation Trust, Hertfordshire Community NHS Trust, Guy’s and St Thomas’ Hospital Foundation Trust, Norfolk and Norwich University Hospital Foundation Trust. Colleagues working in these organisations provided unstinting support throughout and despite considerable clinical pressures, particularly during and following the pandemic, they worked willingly to enable us to complete the work.

We would also like to that the many academic colleagues from our collaborating organisations for their contribution to this programme of research.

A special thank you goes to the DAFNE central team for considering results against on-going real-world audit.

Finally, we would like to express our thanks to colleagues in the NIHR PGfAR funding scheme who provided their forbearance and constructive support throughout the lifetime of this project. Their willingness to grant us additional funded extensions allowed us to complete the work, and in particular the trial which was brought to a halt by the COVID-19 pandemic.

Data-sharing statement

All data requests should be submitted to the corresponding author for consideration. Access to anonymised data may be granted following review.

Ethics statement

Ethical approval for the cluster RCT was granted by the South West – Exeter Research Ethics Committee (reference 18/SW/0100) prior to the trial commencement on 14 May 2018.

Ethical approval for the pilot study was received from the West of Scotland Research Ethics Committee (ref16/WS/0230) on 2 November 2016.

Ethical approval for the early Intervention behavioural change development work was provided by University College London Research Ethics Committee (CEHP/2016/556).

Ethical approval of the preliminary user testing of the prototype Withcare+ and Glucollector systems (a non-NHS sample) was granted by School of Health and Related Research Ethics Committee, University of Sheffield, reference 8381.

Information governance statement

The University of Sheffield is committed to handling all personal information in line with the UK Data Protection Act (2018) and the General Data Protection Regulation (EU GDPR) 2016/679. Under Data Protection legislation the University of Sheffield is the Data Processor; Sheffield Teaching Hospitals NHS Trust is the Data Controller, and we process personal data in accordance with their instructions. You can find out more about how we handle personal data, including how to exercise your individual rights and the contact details for Sheffield Teaching Hospital’s Data Protection Officer here: https://www.sheffieldclinicalresearch.org/for-patients-public/how-is-your-information-handled-in-research/.

Disclosure of interests

Full disclosure of interests: Completed ICMJE forms for all authors, including all related interests, are available in the toolkit on the NIHR Journals Library report publication page at https://doi.org/10.3310/GJSH0917.

Primary conflicts of interest: We endeavour to obtain ICMJE disclosure of interests’ forms for all named authors. In this case, we have been unable to obtain these forms for every author. Please contact the corresponding author if you have any queries.

While none of the co-applicants believe that their previous or current research funding conflicts with their ability to conduct and publish truly independent research on the studies included in this programme, for complete transparency, the potential conflicts of interest statements from the co-applicants are given below.

Simon Heller receives research support income from Dexcom Inc; consulting fees from Eli Lilly, NovoNordisk and Medtronic; and participates on a Data Safety Monitoring Board or Advisory Board for Eli Lily. Any payments are made to his employing institution.

Alan Brennan received grant funding for the following studies: NIHR-funded PGfAR, Type 2 diabetes (T2D) in 16 40 years olds: a multifactorial management intervention to address multimorbidity in early-onset T2D in adults (The M3 Research Programme), Award ID: NIHR201165; NIHR-funded PGfAR, Developing and evaluating a multifactorial intervention to improve cardiovascular outcomes in adults with type 2 diabetes and current or previous diabetic foot ulcers (MiFoot), Award ID: NIHR202021; NIHR-funded PGfAR, Scalable behavioural weight management programmes for the prevention and treatment of type 2 diabetes; Award ID: RP-PG-0216-20010; Astrazeneca funded Knowledge Exchange work, Systematic review of the direct and indirect costs of breast cancer. EU IMI2-funded grant, Hypo-RESOLVE. Grant agreement No 777460, NIHR-funded PDG, Screening for pre-clinical Type 1 diabetes to prevent hospital admission and acute illness at diagnosis: determining the evidence for benefit, acceptability and elements relevant to cost evaluation. Award ID: NIHR203948; and NIHR-funded HTA Clinical Trials & Evaluation, Dietary Approaches to the Management Of type 2 Diabetes (DIAMOND) cluster randomised trial. Award ID: NIHR132317. He receives consulting fees from Eli Lily and Sanofi for Advisory Board contribution.

Dan Pollard received grants or contracts from the following studies: NIHR-funded technology assessment reviews, Production of technology assessment reviews (TARs) for the National Institute for Health Research (NIHR), Award ID: NIHR131947; NIHR-funded HTA Clinical trials and evaluation, The clinical and cost-effectiveness of the DESMOND-ID education programme for adults with intellectual disability and type 2 diabetes, Award ID: NIHR131692; NIHR-funded PGfAR, Type 2 diabetes (T2D) in 16–40 years olds: a multifactorial management intervention to address multimorbidity in early-onset T2D in adults (The M3 Research Programme), Award ID: NIHR201165; NIHR-funded PGfAR, Developing and evaluating a multifactorial intervention to improve cardiovascular outcomes in adults with type 2 diabetes and current or previous diabetic foot ulcers (MiFoot), Award ID: NIHR202021; NIHR-funded PGfAR, Scalable behavioural weight management programmes for the prevention and treatment of type 2 diabetes; Award ID: RP-PG-0216-20010, Astrazeneca-funded Knowledge exchange work, Systematic review of the direct and indirect costs of breast cancer; EU IMI2-funded grant, Hypo-RESOLVE. Grant agreement No 777460; NIHR-funded PDG, Screening for pre-clinical type 1 diabetes to prevent hospital admission and acute illness at diagnosis: determining the evidence for benefit, acceptability and elements relevant to cost evaluation; Award ID: NIHR203948, NIHR-funded HTA Clinical trials and evaluation, Dietary Approaches to the Management Of type 2 Diabetes (DIAMOND) cluster randomised trial; Award ID: NIHR132317, NIHR-funded HTA Commissioned. MATTS: MAjor trauma Triage Tool Study. Award ID: 17/16/04.

Nicole de Zoysa received grant funding from the CLEAR trial grant (NIH) www.isrctn.com/ISRCTN74214605, which was paid to her institution; a honoraria from ‘Diabetes Technology Network’ for training event https://abcd.care/dtn/about-dtn-uk; travel expenses to/from ‘Diabetes UK’ conference for delivering lecture.

Jane Speight received grants or contracts for the following studies: Breakthrough T1D: global summit to end diabetes stigma from diabetes Canada: secondary analysis of international diabetes stigma data; Diabetes Australia: consultation on revision of NDSS resources, MRFF TTRA: HypoPAST trial; Diabetes Victoria: consultation on revision of the Life! Program Curriculum in terms of behaviour change techniques, MRFF TTRA: LISTEN trial; NHMRC: PREDICT cohort studyNIHR: MiFOOT; JDRF (Australia): Australian T1D Screening Pilot, JDRF (USA): Australian T1D Screening Pilot; NHMRC: GooD4Mum, NIHR: M3 Programme; NHMRC: MaGDA-2. She receives royalties from licensing of person-reported outcome measures: HypoA-Q (as copyright holder) and from licensing of person-reported outcome measures: DSAS-1 and DSAS-2 (to research group, the ACBRD, as copyright holder). Consulting fees from VERTEX to serve of the Scientific Advisory Group for a multinational survey of adults with type 1 diabetes. Funding was received from the American Diabetes Association (2024), ISPAD (2024), EASD (2025) towards travel and accommodation expenses in respect of being an invited speaker at these international scientific meetings. Member of the Data Safety Monitoring Board for HARMON-E trial (Deakin University, Food & Mood Centre, Faculty of Health); Chair, International PsychoSocial Aspects of Diabetes (PSAD) Study Group, which serves as a reference group to the European Association for the Study of Diabetes in matters related to the psychological, social and behavioural aspects of diabetes.

Elizabeth Holmes-Truscott received grants or contracts from Diabetes Australia, Diabetes Victoria, Diabetes Canada, NHMRC, MRFF TTRA, and the Heart Foundation, all of which are paid to her institution [Australian Centre for Behavioural Research in Diabetes (ACBRD) provided by the collaboration between Diabetes Victoria and Deakin University]. She was an unpaid member of the Executive Committee of the PsychoSocial Aspects of Diabetes Study Group (2021–4), Behavioral Platform Lead (unpaid) for the Australian Centre for Accelerating Diabetes Innovations (ACADI), the University of Melbourne and Editor for Diabetes Medicine (Honorarium paid to institution).

Uffe Soholm was previously employed by Novo Nordisk A/S, prior to starting on this study (2022–3).

Debbie Cooke is a member of Trial Steering Committee for the PROTECT Trial, funded by the NIHR, ref NIHR150958. She is also Honorary Treasurer, of the Psychosocial Aspects of Diabetes Group.

Susan Michie is an unpaid founder and director of the Unlocking Behaviour Change Community Interest Company (unlockingbehaviourchange.org). Advisor to Godot Inc, a company applying behavioural science and AI to behaviour change.

Stephanie Amiel received grants or contracts from National Institutes of Health, USA, as a Funded investigator on the CLEAR study, and EU-IMI grant HypoRESOLVE Grant funding to King’s College London. She receives consulting fees from Vertex Pharmaceuticals as an Advisory Board member. She received a honorarium and expenses for chairing the Vertex symposium at EASD and a honorarium from Sanofi as Speaker at an educational symposium. She was Chair of Science and Research Advisory Committee, and is Chair, Study Management Group, UKIAb registry study, both for Diabetes UK.

David Hopkins receives grant funding from an EU Innovative Health Initiative Grant, Contract Number 945345; H2O: Health Outcomes Observatory, as Public lead for diabetes workstream across EU wide partnership. Funding received by his host institution (King’s College London). He receives consulting fees as Medical Advisor to the board of My Sugar Watch, a diabetes technology company. He was Chair of Council of Healthcare Professionals at the charity Diabetes UK from 2016 until June 2023, a honorary role supporting Diabetes UK leadership in providing healthcare professional views on policy, and was Chair of SE Thames Diabetes Physicians Group from 2016 to June 2023, a honorary role supporting continuing professional development and training for physicians working in the field of diabetes. He is the owner of Hoplon Ltd, a small-scale medical practice business in Jersey.

Lucy Yardley holds grants from the following studies: NIHR–PGfAR-funded, Supporting self care for eczema in the community, Award ID: RP-PG-0216-20007, NIHR-funded, NIHR Health Protection Research Unit in Evaluation and Behavioural Science, Award ID: NIHR207385, NIHR-funded, Blood borne viruses (BBV) opt out testing extension, Award ID: NIHR200877_BBV, NIHR-funded, The development and evaluation of prehab for elective and urgent cardiac surgery patients (BTC), Award ID: NIHR207502, NIHR-funded, Accessible results: enabling patients with diverse needs to access and understand their blood test results online, Award ID: NIHR159467, NIHR–PGfAR-funded, ARK Digitally Enabled Sustainable Implementation, Award ID: NIHR206517, NHS-funded Bristol, North Somerset and South Gloucestershire CCG, Participatory research fund, coproducing and optimising support for people experiencing homelessness during extreme weather events, Award ID: N/A, NHS-funded, Bristol, North Somerset and South Gloucestershire Integrated Care Board, How can vaccinations be delivered opportunistically in primary care and community settings in a way that is feasible, accessible, and acceptable, and leads to increased vaccine uptake in adults? Award ID: RCF 23/24-2SD, NIHR-funded, Improving primary care antibiotic prescribing to reduce antibiotic resistant urine infections: the IPAP-UTI programme, Award ID: NIHR204400, NIHR-funded, Senior Investigator Award, Award ID: NIHR205057, NIHR-HSDR funded, PHarmacy partnership using decision-making tools and near patient testing for Antimicrobial Stewardship for EveryDay practice IN primary care, Award ID: NIHR158312, NIHR-funded, Interventions to increase vaccine uptake: systematic review and component network meta-analysis to identify the most effective strategies, Award ID: NIHR135130, Wellcome Trust-funded, PhD Programme for Primary Care Clinicians, Award ID: 223501/Z/21/Z, Wellcome Trust – Elizabeth Blackwell Institute Research for Equality, Diversity and Inclusion in Health and Biomedicine-funded, cocreating public health messaging for high-risk populations during extreme weather events, Award ID: Prudence Trust-funded, Improving Adolescent mental health by automating and optimising remote treatment using STTAMP: Sleep Tracking and Treatment for Adolescent Mental health Problems, Award ID: PT-0041, NHS-funded, Opt out blood borne virus testing in emergency departments, Award ID: NIHR200877, NIHR-HSA-funded, Improving Monkeypox Advice, Award ID: NIHR200890, NIHR-funded Efficacy and Mechanism Evaluation, Rapid respiratory microbiological point-of-care-testing in primary care: a randomised controlled trial with internal pilot and qualitative and quantitative investigation of microbial, behavioural and antibiotic mechanisms (the RAPID-TEST RCT), Award ID: NIHR131758, NIHR-PGfAR-funded, Optimising the management of blood pressure following hypertensive pregnancy to reduce cardiovascular risk, Award ID: NIHR203283, NIHR-funded, Interventions to increase vaccine uptake: systematic review and component network meta-analysis to identify the most effective strategies, Award ID: NIHR135130, NIHR–SPCR-funded, Supporting targeting of antibiotics in primary care to combat antimicrobial resistance (STOP AMR): intervention development, Award ID: FR3 – 584, NIHR–PGfAR-funded, Developing and testing an on-line intervention to support self-management, improve outcomes and reduce antibiotic use in acne, Award ID: NIHR202852, Kennisprogramma Huisartsgeneeskunde ZonMw-funded, Effectiveness of analgesic ear drops as add-on treatment to oral analgesics in children with acute otitis media: a pragmatic randomised controlled trial, Award ID: 10060000000000, NIHR–PGfAR-funded, Reducing the impact of diabetic foot ulcers on patients and the health service: the REDUCE programme, Award ID: RP-PG-0618-20001, NIHR-funded Infrastructure, NIHR HPRU Behavioural Science and Evaluation at University of Bristol, Award ID: NIHR200877, NIHR–PGfAR-funded, Development and evaluation of an online FeNO-guided primary care asthma management intervention, Award ID: RP-PG-0618-20002, EPSRC-funded, Centre for Doctoral Training in Digital Health and Care, Award ID: EP/S023704/1, NIHR-funded, NIHR Applied Research Collaboration West (ARC West), Award ID: NIHR200181, NIHR–PGfAR-funded, Reducing Common infections in usual practice for recurrent respiratory tract infections, Award ID: RP-PG-0218-20005, NIHR–PGfAR-funded, Development and evaluation of a complex ePrescribing-based Antimicrobial Stewardship (ePAMS+) intervention for hospitals, Award ID: RP-PG-0617-20009, MRC-funded, Strategies to reduce the burden of antibiotic resistance in China, Award ID: MR/S013717/1, NIHR-funded, Senior Investigator, Award ID: NF-SI-0617-10079, NIHR–PGfAR-funded, Reducing and preventing Cognitive impairment iN older age groups (the RECON programme), Award ID: RP-PG-0615-20014, NIHR–PGfAR-funded, Supporting self care for eczema in the community, Award ID: RP-PG-0216-20007.

Louise Holland is employed by Northumbria Healthcare NHS Foundation Trust as director of DAFNE.

No other authors have declared disclosures of interest.

Copyright and credit statement

Every effort has been made to obtain the necessary permissions for reproduction, to credit original sources appropriately and to respect copyright requirements. However, despite our diligence, we acknowledge the possibility of unintentional omissions or errors and we welcome notifications of any concerns regarding copyright or permissions.

Publications

Breckenridge JP, Gianfrancesco C, de Zoysa N, Lawton J, Rankin D, Coates E. 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 2018;4:120. https://doi.org/10.1186/s40814-018-0314-4

Campbell F, Lawton J, Rankin D, Clowes M, Coates E, Heller S, et al. 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 2018;18:898. https://doi.org/10.1186/s12913-018-3655-z

Eissa MR, Good T, Elliott J, Benaissa M. Intelligent Data-driven model for diabetes diurnal patterns analysis. IEEE J Biomed Health Inform 2020;24:2984–92. https://doi.org/10.1109/jbhi.2020.2975927

Heller SR, Gianfrancesco C, Taylor C, Elliott J. 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 2020;37:545–54. https://doi.org/10.1111/dme.14268

Zaitcev A, Eissa MR, Hui Z, Good T, Elliott J, Benaissa M. A deep neural network application for improved prediction of HbA1c in type 1 diabetes. IEEE J Biomed Health Inform 2020;24:2932–41. https://doi.org/10.1109/jbhi.2020.2967546

Coates E, Amiel S, Baird W, Benaissa M, Brennan A, Campbell MJ, et al. Protocol for a cluster randomised controlled trial of the DAFNE. BMJ Open 2021;11:e040438. https://doi.org/10.1136/bmjopen-2020-040438

Hamilton K, Stanton-Fay SH, Chadwick PM, Lorencatto F, de Zoysa N, Gianfrancesco C, et al. Sustained type 1 diabetes self-management: specifying the behaviours involved and their influences. Diabet Med 2021;38:e14430. https://doi.org/10.1111/dme.14430

Holmes-Truscott E, Cooke DD, Hendrieckx C, Coates EJ, Heller SR, Speight J. 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;38:e14524. https://doi.org/10.1111/dme.14524

Stanton-Fay SH, Hamilton K, Chadwick PM, Lorencatto F, Gianfrancesco C, de Zoysa N, et al. The DAFNEplus programme for sustained type 1 diabetes self-management: intervention development using the Behaviour Change Wheel. Diabet Med 2021;38:e14548. https://doi.org/10.1111/dme.14548

Eissa MR, Benaissa M, Good T, Hui Z, Gianfrancesco C, Ferguson C, Elliott J. Analysis of real-world capillary blood glucose data to help reduce HbA_1c and hypoglycaemia in type 1 diabetes: evidence in favour of using the percentage of readings in target and coefficient of variation. Diabet Med 2022;40:e14972. https://doi.org/10.1111/dme.14972

Heller S. Handing control to the patient – structured education in diabetes. Br J Diabetes 2022;22:S44–7. https://doi.org/10.15277/bjd.2022.363

Zaitcev A, Eissa MR, Hui Z, Good T, Elliott J, Benaissa M. Automatic inference of hypoglycemia causes in type 1 diabetes: a feasibility study. Front Clin Diabetes Healthc 2023;4:1095859. https://doi.org/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;41:e15309. https://doi.org/10.1111/dme.15309

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;41:e15375. https://doi.org/10.1111/dme.15375

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;41:e15371. https://doi.org/10.1111/dme.15371

Holmes-Truscott E, Schipp J, Cooke DD, Hendrieckx C, Coates EJ, Heller SR, Speight J. Perceptions of adults with type 1 diabetes toward diabetes-specific quality of life measures: a survey-based qualitative exploration. Health Qual 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, et al; 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;10:154. https://doi.org/10.1186/s40814-024-01576-3

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;42:e70078. https://doi.org/10.1111/dme.70078

Annual Meeting EASD, 2025. Søholm U, Thuraisingam S, Holmes-Truscott E, de Zoysa N, Cooke D, Heller S, Speight J. for the DAFNEplus Study Group: HbA1c and diabetes-specific quality of life changes following structured type 1 diabetes education: exploratory latent profile analysis in the DAFNEplus trial. 61st Annual Meeting of the European Association for the Study of Diabetes (EASD); 2025.

Papers in preparation

Conference presentations

UK Society for Behavioural Medicine Annual Scientific Meeting Cardiff 2016. Kathryn Dennick, From DAFNE to DAFNEplus: applying a nominal group technique to optimise a diabetes self-management programme using insights from behaviour change science.

British Psychological Society Diabetes Psycho-Social Study Day, Oxford 2017. Nicole de Zoysa, Bringing behaviour change science into the re-design of DAFNE (structured education for type 1 diabetes).

International Society for Pharmacoeconomics and Outcomes Research, Glasgow 2017. Alan Brennan, Expected value of sample information for individual level simulation models to inform stop/go decision making by public research funders: a methodology for the Dafneplus diabetes education cluster RCT.

UK Society for Behavioural Medicine Annual Scientific Meeting, Liverpool 2017. Stephanie Stanton-Fay, Using the behaviour change wheel to refine a self-management programme for type 1 diabetes: developing DAFNEplus.

79^th Scientific Sessions of the American Diabetes Association, San Francisco, 2019. Jane Speight. Quantifying the impact of type 1 diabetes on quality of life: findings of the YourSAY:QoL study.

ISPOR Europe, Copenhagen 2019. Dan Pollard, A health economic and decision modelling analysis plan for an integrated database of over 100 clinical trials measuring hypoglycaemic attacks for people with diabetes: a HEDMAP for hyporesolve.

International Clinical Trials Methodology Conference, Edinburgh 2024. Elaine Scott/Dan Beever, Maximising involvement opportunities in intervention development: reflections from a diabetes education research programme.

Diabetes UK Professional Conference, Glasgow 2025. Heller et al., DAFNEplus – results from the programme.

Cochrane Colloquium Seoul, 2016. Fiona Campbell, Horizon scanning: a new horizon for Cochrane. An example of using horizon scanning to enhance the value of systematic review Accepted, but not presented.

Disclaimers

This article presents independent research funded by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, CCF, PGfAR or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, the PGfAR programme or the Department of Health and Social Care.