Impact case study database

NHS data indicate that 3.4 million people in the UK have T2D; for Scotland alone, there are ~260,000 affected individuals, with 17,000 new cases diagnosed annually. T2D was traditionally considered permanent and inevitably progressive; however, DiRECT showed that sustainable remission can be achieved through a weight-loss intervention delivered within primary care [3.2]. Within 1 year of the primary results, DiRECT had changed understanding, practice and policy at national and international levels.

The DiRECT intervention is adopted into UK policy and strategy

Following the DiRECT 1-year results [3.2], the Scottish Government recommended that

Counterweight-Plus be implemented within NHS Scotland as a core intervention for T2D remission (July 2018). This position is reflected both within the national obesity strategy delivery plan and the national T2D prevention, early detection and early intervention framework (‘the Framework’) [5.A]. The Framework was allocated GBP42 million to improve weight management services, offering Counterweight-Plus as ‘level 3’ (T2D patients) and ‘level 4’ (complex case management) interventions. The Framework also introduces and promotes the term ‘diabetes remission’ throughout its messaging. The Professional Advisor (Programme Lead) to the Framework said, “ DiRECT … has been one of the single most influential pieces of research to change and enhance dietetic practice and the weight management options/services in NHS Scotland for people with Type 2 Diabetes over the last decade*” [5.B]. By April 2019, all 14 NHS Scotland health boards were approved to implement this intervention among eligible patients over the next 5 years. Across Scotland, 500 patients were anticipated to begin in 2019–2020, supported by a GBP3 million budget and Scottish Government guidance that is wholly underpinned by the DiRECT studies [3.2,3.3] [5.B]. As a result, General Practitioners (GP) and other healthcare providers in Scotland can now refer newly diagnosed T2D patients to dietitians within local Weight Management Teams for assessment, which then support eligible patients on the Counterweight-Plus intervention [5.B].

In England, the NHS Long Term Plan launched in January 2019 used DiRECT [3.2] as sole evidence that T2D remission is achievable [5.C]. This pledged to implement an initial 2-year programme supporting low-calorie diets for obese people with T2D [5.C]. Following delay due to Covid-19 disruption, in September 2020, NHS England / NHS Improvement launched the NHS Low Calorie Diet (LCD) programme for 5,000 patients across ten large English Health and Social Care Partnership regions, citing the DiRECT trial and economic analysis [3.5] [5.D]. Independent of this programme, several other regions have trialled Counterweight-Plus for T2D, including North Tyneside, East Berkshire, Homerton (London), and a pilot in Wales with 90 places [5.O].

DiRECT is the largest research study ever supported by Diabetes UK, with T2D remission now representing a major strategic shift for the charity, as noted by the Director of Research: “ The results of the DiRECT study have resulted in a step-change in the understanding of type 2 diabetes and its treatment” [5.E1]. Remission is now one of four cross-organisational priorities for its 2020–2025 strategy [5.E2]. The charity has produced three remission resources web-pages for people with T2D and healthcare professionals (380,000 unique views, Jan 2019–Jun 2020) [5.E1] and an ‘information prescription’ for primary care staff to use with patients [5.E3].

The cost savings from national programmes are estimated to be considerable given that 28% of people with T2D who were approached about DiRECT opted to participate, with ~33% free of T2D and off all medications at 2 years. Antidiabetic drugs represent a fraction of the total healthcare costs of T2D, with inpatient care and medications for complications dominating the average per-patient costs. A revised calculation, based on health economic data [3.5], indicates a net monetary benefit per person of GBP2,517, based on a willingness to pay value of £20,000 per QALY [5.F]. For the 1,500 patients estimated to have been supported on the Counterweight-Plus intervention between 2018–2020, as provided by Counterweight Ltd alone [5.O], this delivers population health impact valued at GBP3.78 million.

Diabetes remission is recognised in practice and perception in the UK and internationally

While DiRECT was aimed at delivery in a UK primary care context, the intervention has been recognised, replicated and adopted internationally. T2D remission is now validated as a treatment endpoint internationally on the basis of DiRECT. The President of the International Diabetes Federation (IDF) said, “ the results of this study [DiRECT] are in my view one of the most important reports regarding management of type 2 diabetes in the last decade…As President of IDF, I travel frequently and speak at international conferences and in the last few months have spoken at meetings in the Middle East, South East Asia, India and also the World Diabetes Congress in Busan, South Korea. At each of these meetings, the topic of the DiRECT study and its seminal results has been a focus of wide interest and discussion” [5.G].

UK: In 2019, the UK Primary Care Diabetes Society and the Association of British Clinical Diabetologists issued a joint position statement emphasising the evidence to support achieving T2D remission and agree criteria for remission (based around the DiRECT criteria) [5.H1]. Primary care physicians now have a route to offer this as a treatment target. This position was also endorsed by DESMOND, the most widely used UK programme providing structured behavioural education to T2D patients [5.H2]. The DiRECT trial is also featured in ‘Hot Topics’ ( NB Medical Education) the leading UK provider of healthcare continuing professional develop-ment courses—widely delivered for annual GP updating in the UK and Australia. In 2019, the Medical Director, NB Medical Education, said “... since the publication of the DiRECT trial and the BMJ paper on diabetes remission, we will have taught approx. 20,000 GPs and practice nurses this topic in the UK alone, and it has been extremely well received as a topic” [5.I].

Qatar: Building on the success of DiRECT, in 2018 the DIADEM-1 study replicated DiRECT in 13 Middle Eastern and North African countries (61% remission rate at 12 months) [5.J1]. Qatar subsequently revised its T2D treatment strategy to include remission clinics. The Director of the Qatar National Obesity Treatment Centre said, “ This initiative, supported by evidence from DiRECT and DIADEM-1, will be linked to the national diabetes screening programme in Qatar… Seeing DiRECT findings translated into the UK NHS has supported the plans for establishment of clinics in Qatar. It is expected that the clinics will be fully operational by May 2021” . The DiRECT and DIADEM-1 findings and interventions formed the basis of the Qatar National Diabetes Prevention Programme , which has been awarded USD25 million to address different stages of T2D [5.J2]

US and Europe: In 2018, the DiRECT trial was described in detail in the Consensus Report of the American Diabetes Association and the European Association for the Study of Diabetes, which identified, for the first time, remission of T2D as a clinical management target [5.K].

Australia: The Vice President of the IDF (Australia) said, “ The DiRECT study has already impacted clinical advice in Australia” [5.L]. The Australian Diabetes Society updated its T2D management algorithm to include intensive weight loss for remission (2020), with DiRECT referred to in the 2020 edition of the Royal Australian College of General Practitioners (RACGP) handbook. In September 2020, the University of Sydney began a DiRECT replication study. “ We expect to observe similar results which in turn will lead to this intervention becoming standard practice for newly diagnosed T2D and inclusion in national management guidelines” [5.L].

Improved patient health and wellbeing

Within the DiRECT study, patients on the intervention reported a greater improvement in quality of life at 12 and 24 months than those on standard care [3.2, 3.3]. Patients also described that the intervention had transformed their lives. For example: " When doctors told me that my pancreas was working again, it felt fantastic, absolutely amazing! I don’t think of myself as a diabetic anymore. I get all my diabetes checks done, but I don’t feel like a diabetic. I am one of the lucky ones to have gone into remission" – Isobel, the first participant in DiRECT; “ By the end of it, my 16 tablets a day went down to zero, my blood pressure which was sky high went back to normal. I felt 10 years younger" − Tony, in remission following Counterweight-Plus [5.M].

The outcomes of implementation are yet to be fully realised due to the 12-month timeframe of the intervention and pause of national services during the 2020 Covid-19 pandemic. An outcomes dataset has yet to be integrated across the Scottish Framework; however, early data from the East of Scotland Partnership (NHS boards Fife, Borders and Lothian) indicate that in Fife 77 people had enrolled, with median weight loss of 17.3 kg (15% body weight) in women and 22.9 kg (17.9% body weight) in men, sufficient to induce T2D remission [5.N1]. The number of Scottish patients coded as in T2D remission in the Scottish SCI-Diabetes registry was 245 in 2017 when DiRECT completed [5.N2]; however, by October 2020 remissions had risen to 2,321 [5.N2]. Outcome data are not yet available for the NHS England LCD programme, but 500 people had been referred to the programme by 31 December 2020 [5.D]. East Berkshire’s small pilot, completed in 2020, saw an average weight loss of 11.5 kg and half of participants achieving T2D remission [5.O].

New commercial benefits

Counterweight Ltd. has been a key partner in delivering Counterweight-Plus. The DiRECT results led to a new investor purchasing the rights to Counterweight Ltd., and incorporating a new company in March 2018, re-structured around Counterweight-Plus for T2D remission. The new CEO of the company said, “ Without DiRECT, Counterweight Ltd would not now exist, nor would we have been in a position to raise any funds” [5.O]. Counterweight Ltd. has seven employees and outsources services to a network of Counterweight-trained dietitians; during the DiRECT trial, 70 dietitians and nurses were trained to support patients on Counterweight-Plus, with a further 150 trained since 2018. Counterweight have increased sales fivefold, from <100 Counterweight-Plus users per year prior to DiRECT (as a weight-loss plan) to ~500 per year since DiRECT (as a T2D remission plan), including patients in NHS Scotland, dietetic services in England and Wales, and those working with independent dietitians [5.O].

The NHS LCD programme has commissioned four UK-based commercial operators to deliver the programme across the 10 sites in England: ICS Health; Oviva UK; Momenta; and Reed Wellbeing [5.D]. Oviva UK (a digital health provider) and ICS Health had pre-existing programmes to support T2D remission, based on DiRECT. In 2019, Oviva UK launched a low-calorie TDR-based 12-month intervention with digital delivery through an NHS Digital approved smart-phone app (Oviva Diabetes 800), available through GP referral. Their Clinical Director said, “ Oviva have taken all of the research from the DiRECT trial, and similar research across the world, and built a year-long intervention called Oviva Diabetes 800”. Following a pilot, since January 2020 the programme has supported 52 people [5.P1]. ICS Health supported NHS North West London to deliver their ‘Diabetes REWIND’ programme, created in response to DiRECT findings, which launched in February 2020 with capacity for 350 participants per month [5.P2].