Improving management of type 1 diabetes in the UK: the Dose Adjustment For Normal Eating (DAFNE) programme as a research test-bed. A mixed-method analysis of the barriers to and facilitators of successful diabetes self-management, a health economic analysis, a cluster randomised controlled trial of different models of delivery of an educational intervention and the potential of insulin pumps and additional educator input to improve outcomes

Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE) ABSTRACT ObjeCtive To compare the effectiveness of insulin pumps with multiple daily injections for adults with type 1 diabetes, with both groups receiving equivalent training in flexible insulin treatment. PartiCiPantsAdults with type 1 diabetes who were willing to undertake intensive insulin treatment, with no preference for pumps or multiple daily injections. Participants were allocated a place on established group training courses that taught flexible intensive insulin treatment ("dose adjustment for normal eating," DAFNE). The course groups (the clusters) were then randomly allocated in pairs to either pump or multiple daily injections.interventiOns Participants attended training in flexible insulin treatment (using insulin analogues) structured around the use of pump or injections, followed for two years. Main OutCOMe MeasuresThe primary outcomes were a change in glycated haemoglobin (HbA1c) values (%) at two years in participants with baseline HbA1c value of ≥7.5% (58 mmol/mol), and the proportion of participants achieving an HbA1c value of <7.5%. Secondary outcomes included body weight, insulin dose, and episodes of moderate and severe hypoglycaemia. Ancillary outcomes included quality of life and treatment satisfaction. results 317 participants (46 courses) were randomised (156 pump and 161 injections). 267 attended courses and 260 were included in the intention to treat analysis, of which 235 (119 pump and 116 injection) had baseline HbA1c values of ≥7.5%. Glycaemic control and rates of severe hypoglycaemia improved in both groups. The mean change in HbA1c at two years was −0.85% with pump treatment and −0.42% with multiple daily injections. Adjusting for course, centre, age, sex, and accounting for missing values, the difference was −0.24% (−2.7 mmol/mol) in favour of pump users (95% confidence interval −0.53 to 0.05, P=0.10). Most psychosocial measures showed no difference, but pump users showed greater improvement in treatment satisfaction and some quality of life domains (dietary freedom and daily hassle) at 12 and 24 months. COnClusiOnsBoth groups showed clinically relevant and long lasting decreases in HbA1c, rates of severe hypoglycaemia, and improved psychological measures, although few participants achieved glucose levels currently recommended by national and international guidelines. Adding pump treatment to structured training in flexible intensive insulin treatment did not substantially enhance educational benefits on glycaemic control, hypoglycaemia, or psychosocial outcomes in adults with type 1 diabetes. These results do not support a policy of providing insulin pumps to adults with poor glycaemic control until the effects of training on participants' level of engagement in intensive self management have been determined. trial registratiOn Current Controlled Trials ISRCTN61215213.

OBJECTIVE To develop and pilot a novel intervention addressing motivational and cognitive barriers to avoiding hypoglycemia in people with type 1 diabetes and persistent impaired awareness of hypoglycemia (IAH) despite training in flexible insulin therapy. RESEARCH DESIGN AND METHODS A 6-week intervention using motivational interviewing and cognitive behavioral techniques was designed. Diabetes educators were trained and supported in its delivery to 23 people with IAH (Gold score ‡4). RESULTS Twelve months postcourse, hypoglycemia awareness had improved (P < 0.001). Median (range) rates of severe hypoglycemia (SH) fell from 3 (0-104) to 0 (0-3) per person per year (P < 0.0001) and moderate from 14 (0-100) to 0 (0-18) per person per 6 weeks (P < 0.001). Worry and behavior around hyperglycemia improved. HbA 1c was unchanged. CONCLUSIONS A pilot intervention targeting motivation and cognitions around hypoglycemia engaged patients with resistant IAH and recurrent SH and was associated with significant improvement, supporting the hypothesis that these factors underpin problematic hypoglycemia. Hypoglycemia and fear of hypoglycemia remain major barriers to achieving optimal glucose control and quality of life for people with type 1 diabetes. Structured education in flexible insulin therapy (e.g., the U.K.'s Dose Adjustment for Normal Eating [DAFNE]) and/or use of insulin pump therapy reduces severe hypoglycemia (SH) (1), but some continue to experience impaired awareness of hypoglycemia (IAH) with high rates of SH, their problematic hypoglycemia resistant to intervention. We hypothesized that many such people have motivational and cognitive barriers to hypoglycemia avoidance and resolution of IAH. We designed and piloted an intervention using motivational interviewing and cognitive behavioral theory targeting these barriers.

myfood24 is an online 24 hr dietary recall tool developed for nutritional epidemiological research. Its clinical application has been unexplored. This mixed methods study explores the feasibility and usability of myfood24 as a food record in a clinical population, women with gestational diabetes (GDM). Women were asked to complete five myfood24 food records, followed by a user questionnaire (including the System Usability Scale (SUS), a measure of usability), and were invited to participate in a semi-structured interview. Of the 199 participants, the mean age was 33 years, mean booking body mass index (BMI) 29.7 kg/m2, 36% primiparous, 57% White, 33% Asian. Of these, 121 (61%) completed myfood24 at least once and 73 (37%) completed the user questionnaire; 15 were interviewed. The SUS was found to be good (mean 70.9, 95% CI 67.1, 74.6). Interviews identified areas for improvement, including optimisation for mobile devices, and as a clinical management tool. This study demonstrates that myfood24 can be used as an online food record in a clinical population, and has the potential to support self-management in women with GDM. However, results should be interpreted cautiously given the responders’ demographic characteristics. Further research to explore the barriers and facilitators of uptake in people from ethnic minority and lower socioeconomic backgrounds is recommended.

Background High‐quality nutrition education is recommended as an essential component of diabetes care. In the UK, there has been a gradual shift of inter‐professional boundaries with respect to providing nutritional care for people with type 2 diabetes. Only a minority now regularly receive advice from a dietitian. Instead, increased demands for nutrition education are being absorbed by practice nurses. The present study seeks to explore this situation through the views of practice nurses on the services that they provide and the issues they face. Methods A qualitative approach using semi‐structured interviews was employed. Practice nurses were recruited using purposive sampling, and nine were interviewed. Data were analysed using the Framework Method. The Theoretical Domains Framework from the COM‐B (‘capability’, ‘opportunity’, ‘motivation’ and ‘behaviour’) model of behaviour change, as increasingly employed to explore the behaviour of healthcare professionals, was used to further frame the findings. Results Practice nurses reported that ongoing diabetes nutrition education only took place at annual review appointments and was limited to 5–10 min. They described how they are expected to take on a more advanced role in diabetes nutrition education than they can provide and are becoming increasingly isolated in this role as a result of a lack of time, practical and informational support, and training standards and provision. Conclusions A range of service improvements led by dietitians, which focus on strengthening the working environment and enhancing professional support available for practice nurses who provide diabetes nutrition education, could improve quality of care and health outcomes in people with diabetes within current time restraints.

Aims: Sustained engagement in type 1 diabetes self-management behaviours is a critical element in achieving improvements in glycated haemoglobin (HbA1c) and minimising risk of complications. Evaluations of self-management programmes, such as Dose Adjustment for Normal Eating (DAFNE), typically find that initial improvements are rarely sustained beyond 12 months. This study identified behaviours involved in sustained type 1 diabetes self-management, their influences and relationships to each other. Methods: A mixed-methods study was conducted following the first two steps of the Behaviour Change Wheel framework. First, an expert stakeholder consultation identified behaviours involved in self-management of type 1 diabetes. Second, three evidence sources (systematic review, healthcare provider-generated 'red flags' and participant-generated 'frequently asked questions') were analysed to identify and synthesise modifiable barriers and enablers to sustained self-management. These were characterised according to the Capability-Opportunity-Motivation-Behaviour (COM-B) model. Results: 150 distinct behaviours were identified and organised into three self-regulatory behavioural cycles, reflecting different temporal and situational aspects of diabetes self-management: Routine (e.g. checking blood glucose), Reactive (e.g. treating hypoglycaemia) and Reflective (e.g. reviewing blood glucose data to identify patterns). Thirty-four barriers and five enablers were identified: 10 relating to Capability, 20 to Opportunity and nine to Motivation. Conclusions: Multiple behaviours within three self-management cycles are involved in sustained type 1 diabetes self-management. There are a wide range of barriers and enablers that should be addressed to support self-management behaviours and improve clinical outcomes. The present study provides an evidence base for refining and developing type 1 diabetes self-management programmes.This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Health professionals including diabetes specialist nurses and dietitians should explore: patients' access to and preferences for social support; how patients might be encouraged to capitalise on social support postcourse; and new ways to inform/educate people within patients' social networks.

BackgroundRandomised controlled trials (RCTs) of complex interventions often begin with a pilot phase to test the proposed methods and refine the intervention before it is trialled. Although the Medical Research Council (MRC) recommends regular communication between the practitioners delivering the intervention and the researchers evaluating it during the pilot phase, there is a lack of practical guidance about how to undertake this aspect of pre-trial work. This paper describes a novel structured process for collaborative working, which we developed to iteratively refine a complex intervention prior to an RCT. We also describe an in-built qualitative study to learn lessons about how this approach could be used by future study teams.MethodsThis work forms part of a broader research programme to develop and trial a complex intervention for people with type 1 diabetes, called DAFNEplus. The intervention is being piloted in three National Health Service (NHS) diabetes centres in two waves, with refinements being incrementally implemented between each wave in response to real-time, collective learning (combining practitioner experience, process evaluation data and patient and public involvement via an advisory group). A structured ‘Collaborative Working Group’ (CWG) process, comprising monthly teleconferences and four strategically timed face-to-face meetings, is being used to identify and respond systematically to emerging implementation challenges and research findings. The group involves 25 members of the study team, including the multi-disciplinary practitioners delivering the intervention, the research teams conducting the process evaluation, the study manager and Chief Investigator. An in-built qualitative study comprising documentary analysis of meeting materials, discourse analysis of meeting transcripts, reflexive note taking, and thematic analysis of focus groups and interviews with CWG members is being undertaken to explore how the CWG works and how its processes and procedures might be improved.DiscussionThe CWG process offers a potential model for collaborative working in future pre-trial pilot phases and intervention development studies that operationalises MRC guidance to progressively develop a complex intervention and foster shared ownership through genuine collaboration. The findings from the qualitative study will provide insight into how to best support collaborative working to achieve optimal intervention design.