Carla Gianfrancesco

Background: Dose Adjustment For Normal Eating is a 5-day, group-based clinical education programme for adults with type 1 diabetes, training them in the complex self-management skills, enabling them to optimise both their glycaemic management and quality of life. Although Dose Adjustment For Normal Eating is associated with improvements in many aspects of diabetes management, including psychological outcomes, it has been challenging to maintain the biomedical improvements for longer term, which have remained well above the glucose levels recommended by National Institute for Health and Care Excellence. Objectives: We aimed to develop and evaluate Dose Adjustment For Normal Eating plus , an enhanced version of Dose Adjustment For Normal Eating, to enable improvements in glycaemic management (glycated haemoglobin) without compromising the quality of life. The objectives of the programme were to modify the existing Dose Adjustment For Normal Eating curriculum and evaluate it in a cluster randomised controlled trial. Design: This programme comprised four workstreams. The first three workstreams focused on redevelopment of the Dose Adjustment For Normal Eating intervention to become ‘Dose Adjustment For Normal Eating plus ’: involving revision of the curriculum for a 5-day, group-based programme, including relevant behaviour change techniques (workstream 1); development of a new structured, pro-active, follow-up programme to be delivered by Dose Adjustment For Normal Eating plus facilitators post course to support ongoing diabetes self-management (workstream 2); and development of a new technology interface to help glucose pattern recognition to inform improved self-management (workstream 3). We used mixed methods to review, develop and refine the Dose Adjustment For Normal Eating plus intervention (course, individual support and technological aspects). The intervention was piloted in three National Health Service specialist diabetes centres and was reviewed via two iterative waves before finalisation. Workstream 4 was a cluster randomised controlled trial using a pragmatic, parallel group (1 : 1) allocation design (Dose Adjustment For Normal Eating vs. Dose Adjustment For Normal Eating plus ), with concurrent process and health economic evaluations. The primary biomedical outcome was the between-group difference in glycated haemoglobin at 12 months. The primary psychological outcome was the between-group difference in the impact of type 1 diabetes on quality of life (using Audit of Diabetes-Dependent Quality of Life-15) at 12 months. Setting: The workstreams and the randomised controlled trial were undertaken in university and National Health Service specialist centres in England and Scotland. Participants: Four hundred and seventy-one adults aged ≥ 18 years with confirmed diagnosis of type 1 diabetes participated in the cluster randomised controlled trial, which was 144 fewer than planned and approximately 77% of the planned sample size. Intervention: Dose Adjustment For Normal Eating plus is a standardised 5-day educational course (described above), delivered 1 day per week over 5 weeks in groups, meeting face to face, followed by five individual support sessions over 12 months. An online platform supports the upload, visualisation, pattern recognition and review of glycaemic data for participants and clinicians. Trial outcome measures: In the cluster randomised controlled trial, the primary biomedical outcome was glycaemia, defined as glycated haemoglobin, at 12 months. The primary psychological outcome was the impact of diabetes on quality of life (assessed using the widely recognised scale, Audit of Diabetes-Dependent Quality of Life-15). Key secondary biomedical outcomes included rates and proportions of severe hypoglycaemia and diabetic ketoacidosis. Key secondary psychological outcomes included diabetes-specific distress, diabetes-specific positive well-being and fear of hypoglycaemia. Results: In the primary intention-to-treat population (309), mean glycated haemoglobin reduced from 9.1% to 8.2% (75.9–66.5 mmol/mol) in the Dose Adjustment For Normal Eating group and from 9.1% to 8.1% (75.6–65.1 mmol/mol) in the Dose Adjustment For Normal Eating plus group. The cluster randomised controlled trial showed no evidence of a between-group difference at 12 months in glycated haemoglobin {point estimate [95% confidence interval −0.014 (−0.284 to 0.255); p = 0.915]}, or diabetes-specific quality of life {point estimate [95% confidence interval 0.2 (−0.1 to 0.5); p = 0.21]}. At 12 months, significant between-group differences were observed, favouring Dose Adjustment For Normal Eating plus , in secondary psychological outcomes (diabetes-specific distress, diabetes-specific positive well-being and actions taken to avoid hypoglycaemia). Limitations: Due to trial-suspension during coronavirus disease, we recruited 471 adults to the cluster randomised controlled trial, 144 fewer than planned. Although this reduced overall statistical power, we showed that the difference in glycated haemoglobin between the groups was far below that we considered a meaningful clinical difference (0.5%). Recruitment also meant that more participants were using continuous glucose monitoring, both before and during the trial than we anticipated. This may have reduced additional benefit of the Dose Adjustment For Normal Eating plus intervention on glycated haemoglobin. The pandemic probably influenced diabetes self-management during the trial in both groups. Conclusions: Dose Adjustment For Normal Eating plus did not lead to greater falls in glycated haemoglobin at 12 months compared to Dose Adjustment For Normal Eating, but these falls were double those reported in previous Dose Adjustment For Normal Eating randomised controlled trials. Sixty-eight per cent of participants showed clinically relevant improved glucose levels. Those in Dose Adjustment For Normal Eating plus reported significant falls in diabetes distress, positive well-being and qualitative research reported positive experiences of Dose Adjustment For Normal Eating plus among participants and health professionals. Future work: In view of major improvements in diabetes distress and positive experiences in both participants and health professionals, the Dose Adjustment For Normal Eating executives, who co-ordinate the delivery of Dose Adjustment For Normal Eating courses, are planning to include key elements of Dose Adjustment For Normal Eating plus in future courses, particularly structured support to participants following the course and key elements of the curriculum. Study registration: This study is registered as IRAS: 235621 and ISRCTN: 42908016. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: RP-PG-0514-20013) and is published in full in Programme Grants for Applied Research ; Vol. 14, No. 21. See the NIHR Funding and Awards website for further award information.

Background: Integrating digital dietary assessment within dietetic care could save time and reduce costs, at the same time as increasing patient engagement. The present study explores the feasibility of implementing a web‐based dietary assessment tool, myfood24 (https://www.myfood24.org), into routine healthcare.Methods: This mixed methods feasibility study recruited dietitians and patients from a National Health Service (NHS) hospital outpatient setting. Patients completed and shared three online 24‐h dietary recalls in advance, which were used as a dietary assessment by dietitians. Recruitment data were collected and questionnaires on technology, usability, and acceptability were completed. Patient interviews and focus groups with dietitians were conducted.Results: Eleven dietitians working in allergy, bariatrics, diabetes, oncology, general, renal, infectious diseases, and coeliac services took part with 39 patients. Recruitment rates were highest in bariatrics and lowest in renal and oncology.Compared to other studies, completion rates were good, with 29 (74.4%) completing three recalls despite lower technology readiness and software usability scores than in similar studies. Illness and difficulty with technology were reasons for non‐completion. Opportunity to receive nutritional feedback from the tool and share this with a dietitian motivated patients to complete the record accurately. Consultation times were shortened in approximately one‐third of appointments and a higher proportion of time was spent on nutritional education compared to usual practice. However, mean preparation time increased by 13 min per appointment because dietitians found nutritional analysis reports difficult to interpret.Conclusions: It is feasible to introduce a digital dietary assessment tool into NHS dietetic practice. However, further development is needed to ensure that the tool is suitable for healthcare.

The last 20 years have witnessed a marked change in approaches to the management of type 1 diabetes in the UK. This is exemplified by National Institute of Health and Care Excellence (NICE) guidance which acknowledges that reaching and maintaining target glucose depends on people with type 1 diabetes effectively implementing flexible intensive insulin therapy. The guidance emphasizes that successful self‐management requires the acquisition of complex skills and is best achieved by participation in high‐quality structured education. Controlled trials and other research have shown that programmes teaching self‐management can lower glucose levels while reducing hypoglycaemia, improve psychological outcomes and are highly cost‐effective. An important principle of successful programmes is therapeutic education in which learning becomes a partnership between the professional and the person with diabetes who learns to fit diabetes into his/her everyday life. Other recommended elements of programmes include a written curriculum, group teaching by a professional multidisciplinary team and quality assurance. Yet many participants struggle post‐course to implement and maintain skills, and overall HbA_1c levels, particularly in the UK, remain far from target. Recent studies have identified the barriers to sustained effective self‐management and concluded that even high‐quality programmes generally lack critical components. These include incorporating evidence from behaviour change research, exploiting the promise of new technologies in reducing the burden of self‐management, and providing structured professional support once people have completed the training. Studies are currently underway to evaluate structured training courses which have added these elements and examine whether they can lower glucose to levels closer to target without impairing quality of life.

This study examines nutritional intakes in Gestational diabetes mellitus piloting the myfood24 tool, to explore frequency of meals/snacks, and daily distribution of calories and carbohydrates in relation to glycaemic control. A total of 200 women aged 20–43 years were recruited into this prospective observational study between February 2015 and February 2016. Diet was assessed using myfood24, a novel online 24-h dietary recall tool. Out of 200 women 102 completed both ≥1 dietary recalls and all blood glucose measurements. Blood glucose was self-measured as part of usual care. Differences between groups meeting and exceeding glucose targets in relation to frequency of meal/snack consumption and nutrients were assessed using chi-squared and Mann–Whitney tests. Women achieving a fasting glucose target p = 0.04) and three snacks (10% vs. 4%: p = 0.06) per day, compared with two or less; and in relation to evening snacks, consumed a higher percentage of daily energy (6% vs. 5%: p = 0.03) and carbohydrates (8% vs. 6%: p = 0.01). Achieving glycaemic control throughout the day was positively associated with snacking (p = 0.008). Achieving glucose targets was associated with having more snacks across the day, and may be associated with frequency and distribution of meals and nutrients. A larger study is required to confirm this.

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.

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.

Myfood24 is a comprehensive self-completed online 24-hour dietary recall tool currently used for nutritional assessments in epidemiological research. However, its clinical application has been unexplored. This mixed methods prospective observational study explores the acceptability and usability of myfood24 in a clinical population, women with gestational diabetes (GDM). Women were recruited at their first diabetes antenatal clinic appointment. To assess acceptability and usability, they were asked to complete five 24-hour dietary recalls using myfood24 over two weeks and a user experience questionnaire; with a subset invited to participate in a one-to-one semi-structured interview. Of the 199 participants, mean maternal age was 33 years, mean booking BMI 29.7kg/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. Usability of myfood24 was measured using the System Usability Scale (SUS) and found to be good (mean 70.9, 95%CI 67.1, 74.6). Interviews identified several areas for improvement, including optimising its use for mobile devices. myfood24 appears to be acceptable and have potential to support self-management and behaviour change for women with GDM but requires adaptation to record blood glucose results alongside real-time tracking of diet.

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.

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.

Aims and objectives: To explore patients' experiences of, views about and need for, social support after attending a structured education programme for type 1 diabetes.Background: Patients who attend structured education programmes attain short‐term improvements in biomedical and quality‐of‐life measures but require support to sustain self‐management principles over the longer term. Social support can influence patients' self‐management practices; however, little is known about how programme graduates use other people's help.Design: This study was informed by the principles of grounded theory and involved concurrent data collection and analysis. Data were analysed using an inductive, thematic approach.Methods: In‐depth interviews were undertaken postcourse, six and 12 months later, with 30 adult patients with type 1 diabetes recruited from Dose Adjustment for Normal Eating courses in the United Kingdom.Results: Patients' preferences for social support from other people ranged from wanting minimal involvement, to benefiting from auxiliary forms of assistance, to regular monitoring and policing. New self‐management skills learnt on their courses prompted and facilitated patients to seek and obtain more social support. Support received/expected from parents varied according to when patients were diagnosed, but parents' use of outdated knowledge could act as a barrier to effective support. Support sought from others, including friends/colleagues, was informed by patients' domestic/employment circumstances.Conclusion: This study responds to calls for deeper understanding of the social context in which chronic illness self‐management occurs. It highlights how patients can solicit and receive more social support from family members and friends after implementing self‐care practices taught on education programmes.Relevance to clinical practice: 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.