Type 2 diabetes remission project: Remission in Diabetes (REMI.D)

This North East T2D remission project REMI.D was a local delivery pilot funded by Sport England and designed with the potential to offer impact at scale (SportEngland, 2021). The guiding principles for the REMI.D project included (a) developing collaborations and partnerships with T2D experts both locally and nationally, (b) using and building on local assets, (c) offering a range of T2D remission dietary and physical activity interventions to address barriers to engagement and enable people living with T2D to take part and (d) increasing control for people with T2D over their health and lives.

A diabetes development group was convened in 2020 following the successful bid. This group brought together key local stakeholders from the local authorities (health improvement managers and public health practitioners), primary and secondary care (practice managers, practice nurses, consultant diabetologists/endocrinologists and diabetes dietitians), universities, NHS England commissioning, Diabetes UK, Sport England, Everyone Active and Active Partnerships.

Current trial data suggest that the most successful approaches to T2D remission are bariatric surgery or total diet replacement (TDR) using formula food products (Taylor et al., 2021). The majority of patients with T2D access non-surgical treatment for overweight and obesity (NHS, 2023c). The Diabetes Remission Clinical Trial (DiRECT), a TDR intervention, showed that after 5 years, almost one-quarter of participants remained in diabetes remission with an average weight loss of almost 9 kg (DUK, 2023b; Lean et al., 2018, 2019). However, the Diabetes UK position statement on T2D remission continues to recommend an individualised approach, recognising that people with T2D have achieved remission using various dietary interventions, including the Mediterranean (‘healthy’) diet, calorie-controlled (low-fat) diets, low-carbohydrate diets and TDR (DUK, 2021). Type 2 diabetes remission may be defined as an HbA1c <48 mmol/mol maintained without diabetes medications for at least 3 months (DUK, 2021; Nagi et al., 2019).

The REMI.D T2D remission project differed from the DiRECT trial in that in the REMI.D project, TDR formula food products were self-funded by participants and a structured physical activity component was also included. A choice of dietary and physical activity strategies was offered in an attempt to reduce barriers to engagement for patients living in an area of significant deprivation. Eligible patients were presented with a choice of three dietary options (a) formula food products TDR, (b) food-based TDR and (c) healthy lifestyle plan. The healthy lifestyle approach supported participants to set tailored goals based on other commonly used dietary strategies for the management of T2D: Mediterranean diet, portion-controlled (lower carbohydrate, higher protein and lower calorie) and/or lower glycaemic index foods. Similarly, there was a choice of three physical activity pathways (a) everyday life (walking, climbing stairs and getting off the bus early), (b) general practitioner (GP) referral (gym, swimming and chair-based exercises) and (c) social hub (activity indirectly through social activities and day trips).

The REMI.D project eligibility criteria (Data S1) followed the NHS England real-world implementation model for the delivery of a TDR-based intervention for people with T2D (NHS, 2023b). The REMI.D project planned that GPs and practice nurses, located within the two local authorities, would identify suitable patients with T2D for inclusion in the T2D remission project. The dietary interventions were to be delivered at the general practices with initial support from the project dietitian (a dietitian on secondment from NHS employment). Figure 1 summarises the T2D remission strategies offered at the beginning of 2020 (pre-COVID-19 pandemic).

The COVID-19 pandemic and the associated lockdowns meant that it was not possible to deliver these strategies. The REMI.D stakeholders made revisions to the intended T2D remission project in March 2022 (Figure 2), due to the loss of primary care stakeholder engagement (GP and practice nurses) during and following the COVID-19 pandemic (Finch, 2022). These changes resulted in the project dietitian taking sole responsibility for both the recruitment and the delivery of the dietary interventions, and the latter being relocated out of general practice.

Sixty-five patients were recruited to the REMI.D project by the project dietitian out of the proposed 200 patients. The decision to stop recruitment took into consideration the capacity of the project dietitian, the duration of the intervention (52 weeks) and the finite funding. Twenty of these patients participated in qualitative research exploring barriers and enablers to engagement with this T2D remission strategy. The descriptive statistics and qualitative research findings are under review for publication elsewhere.

The aim of this process evaluation was to learn from the reactive decisions taken by stakeholders which altered the REMI.D project in response to the COVID-19 pandemic.

Process evaluation

A process or implementation fidelity evaluation determines whether an intervention has been implemented as intended and may be conducted periodically throughout the life of a project (Carroll et al., 2007). Despite increasing awareness of the importance of fidelity in complex healthcare interventions over the past 20 years, the assessment and impact of fidelity is often under-reported (McGee et al., 2018). The latest UK Medical Research Council (MRC) and National Institute for Health Research (NIHR) framework (Figure 3) recognises the need for such evaluations to maximise the efficiency, use and impact of research (Skivington et al., 2021a, 2021b).

Lack of effective collaboration

Perception of change

Scalability of the intervention

While flexibility and agility are essential in any real-world setting research, it is for the stakeholders to judge the significance of the REMI.D project changes (Gordon, 2021). Here, the REMI.D stakeholders identified three challenges that called into question the viability of this T2D remission project (a) the novelty of intervention, (b) the referral pathway and (c) lack of primary care engagement.

Lack of effective collaboration

This T2D remission project required interprofessional collaboration, the perspectives of multiple stakeholders and effective teamwork across hierarchical organisational levels (Norris et al., 2017). Although the physical activity component of this project provided the funding for this project, the dietary intervention and the secondary care stakeholders were initially given more power and status. The DiRECT trial format, a primary care-based dietary intervention, was seen as the way to embed physical activity into a primary care-based T2D remission strategy (DUK, 2023b; Lean et al., 2019). A discussion around re-purposing the funding elsewhere in late 2022 resulted in a more open and honest dialogue between the local authorities and secondary care stakeholders and a renewed focus on the physical activity offer.

Differing stakeholder agendas and levels of engagement raised questions about implementation fidelity, for example, equal promotion of both dietary and activity elements from the outset of the intervention, and perceived resistance to exploration of an alternative digital delivery method. Norris et al. (2017) described three interrelated components of engagement (a) active participation and commitment from stakeholders; (b) shared stakeholder focus and decision-making around relevant change; and (c) two-way communication, early in the change process, where stakeholders felt heard and understood. Arguably more explicit project theory (detailing stakeholder roles and responsibilities) may have increased confidence within the diabetes development group around delivery priorities (dietary vs. physical activity) of the intervention (Skivington et al., 2021b).

Perception of change

The funder (Sport England) promoted a ‘test and learn’ approach to this pilot project. While clinical outcomes were important to the diabetes development group, Sport England was focused on creating blueprints for effective collaboration with healthcare professionals which would enable them to identify and tackle patient barriers to increasing physical activity. This flexibility and willingness to continue funding the T2D remission project despite major refinements to both recruitment and delivery methods enabled a primary care-based project to become a secondary care-based project post the COVID-19 pandemic. The question of whether the findings of this process evaluation would have influenced funding review decisions differently is unknown.

Other unanswered questions are how primary care practitioners felt about no longer being involved in the project post the COVID-19 pandemic, and whether practice nurses have time to take part in this type of T2D mission project. This evaluation project was unable to use and build on local assets within primary care, despite the attempts of the diabetes development group to re-engage with previously committed and new general practices. Stakeholders perceived a change in the preferences of primary care practitioners to one of signposting to, rather than delivery of, the REMI.D project. Practice nurses in Australia have previously shared the challenges faced when implementing a dietary intervention as part of their regular work practices, due to interruptions and concurrent commitments (Govindasamy et al., 2022).

Interestingly, co-production was absent from the project delivery. The term ‘co-production’ describes working in partnership by sharing power between people who draw on care and support (C4PC, 2020). The patient voice is part of the qualitative research arm of this project but was not represented in the diabetes development group. Stakeholder opinions about patient choices of dietary and physical activity interventions and changes post the COVID-19 pandemic were speculative.

Scalability of the intervention

The vision of scalable, successful dietary and physical activity interventions leading to T2D remission or delayed progression with deprescribing of diabetes medications is unlikely to be realised without a renewed commitment from primary care stakeholders. Uncertainty expressed by some stakeholders about the capability of nurses giving dietary advice and, in turn, the confidence of patients receiving it, may be resolved through knowledge and skills training. The planned behaviour change training for primary care was cancelled due to the onset of the COVID-19 pandemic. Rehackova et al. (2022) noted training provided for a specific dietary intervention was positively received by healthcare professionals (nurses and dietitians).

At the heart of this project was physical activity and the desire to influence physical inactivity associated with health inequalities in this ‘place’ (local authorities) by identifying and overcoming barriers to participation. While the physical activity professional was still able to work with the patients recruited and offer physical activity solutions, the demographic of patients taking part may have differed due to the project changes made; patients from more deprived areas may not have understood the significance of the REMI.D project following invitation by letter as opposed to referral by their GP or practice nurse, compared to those from affluent areas (Stokes et al., 2019). This change in the referral process may have negated an opportunity to reduce health inequalities locally.

A return to traditional dietetic-led one-to-one dietary interventions resulted in individually tailored diabetes patient care and potentially less scripted and scalable dietary strategies intended for use by practice nurses. Interestingly, Rehackova et al. (2022) recently concluded that a level of tailoring of interventions to patients in the DiRECT trial helped to sustain health behaviour modification. Achieving positive outputs by delivery in primary care in a reimagined way may still create an opportunity to secure ongoing local funding for this T2D remission model.