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. HbA1c 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.

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.

Randomised 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. This 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. The 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.