Background:

Many adults with type 1 diabetes cannot self-manage their diabetes effectively and die prematurely with diabetic complications as a result of poor glucose control. Following the positive results obtained from a randomised controlled trial (RCT) by the Dose Adjustment For Normal Eating (DAFNE) group, published in 2002, structured training is recommended for all adults with type 1 diabetes in the UK.

Aim:

With evidence that blood glucose control is not always improved or sustained, we sought to determine factors explaining why some patients benefit from training more than other patients, identifying barriers to successful self-management, while developing other models to make skills training more accessible and effective.

Findings:

We confirmed that glycaemic outcomes are not always improved or sustained when the DAFNE programme is delivered routinely, although improvements in psychosocial outcomes are maintained. DAFNE courses and follow-up support is needed to help participants instil and habituate key self-management practices such as regular diary/record keeping. DAFNE graduates need structured professional support following training. This is currently either unavailable or provided ad hoc without a supporting evidence base. Demographic and psychosocial characteristics had minimal explanatory power in predicting glycaemic control but good explanatory power in predicting diabetes-specific quality of life over the following year. We developed a DAFNE course delivered for 1 day per week over 5 weeks. There were no major differences in outcomes between this and a standard 1-week DAFNE course; in both arms of a RCT, glycaemic control improved by less than in the original DAFNE trial. We piloted a course delivering both the DAFNE programme and pump training. The pilot demonstrated the feasibility of a full multicentre RCT and resulted in us obtaining subsequent Health Technology Assessment programme funding. In collaboration with the National Institute for Health Research (NIHR) Diabetes Research Programme at King’s College Hospital (RG-PG-0606-1142), London, an intervention for patients with hypoglycaemic problems, DAFNE HART (Dose Adjustment for Normal Eating Hypoglycaemia Awareness Restoration Training), improved impaired hypoglycaemia awareness and is worthy of a formal trial. The health economic work developed a new type 1 diabetes model and confirmed that the DAFNE programme is cost-effective compared with no structured education; indeed, it is cost-saving in the majority of our analyses despite limited glycated haemoglobin benefit. Users made important contributions but this could have been maximised by involving them with grant writing, delaying training until the group was established and funding users’ time off work to maximise attendance. Collecting routine clinical data to conduct continuing evaluated roll-out is possible but to do this effectively requires additional administrator support and/or routine electronic data capture.

Conclusions:

We propose that, in future work, we should modify the current DAFNE curricula to incorporate emerging understanding of behaviour change principles to instil and habituate key self-management behaviours that include key DAFNE competencies. An assessment of numeracy, critical for insulin dose adjustment, may help to determine whether or not additional input/support is required both before and after training. Models of structured support involving professionals should be developed and evaluated, incorporating technological interventions to help overcome the barriers identified above and enable participants to build effective self-management behaviours into their everyday lives.

Trial registration:

ClinicalTrials.gov NCT01069393.

Funding:

The NIHR Programme Grants for Applied Research programme.

Article history

The research reported in this issue of the journal was funded by PGfAR as project number RP-PG-0606-1184. The contractual start date was in October 2007. The final report began editorial review in July 2013 and was accepted for publication in April 2014. As the funder, the PGfAR programme agreed the research questions and study designs in advance with the investigators. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The PGfAR editors and production house have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report.

Declared competing interests of authors

Simon Heller has provided consultancy (for which the University of Sheffield has received payment) for Johnson & Johnson, who make blood glucose monitoring equipment, NovoNordisk and Eli Lilly who manufacture insulin. He has also given talks on behalf of NovoNordisk and Eli Lilly for which he has received payment. Gill Thompson is employed by Northumbria Healthcare NHS Foundation Trust (NHCFT) in the sole capacity of National Director – DAFNE Programme. Her salary is paid by NHCFT with funds provided by the DAFNE programme. Stephanie Amiel was an invited speaker at a pharmaceutical company-funded symposia (Eli Lilly and Company, Medtronic, Inc. and Abbott Laboratories). Her fees were paid to King’s College London and her expenses were paid. Candice Ward was paid personal fees as a member of the advisory board of Cellnovo and conference speaker fees by Animas® Corporation, Cellnovo and Medtronic, Inc. Candice Ward was involved in research collaborations/projects on the use of medical devices in type 1 diabetes within the Institute of Metabolic Science; funding paid to Cambridge University Hospitals NHS Foundation Trust for service costs.