Since the first National Diabetes audit in 2004, the annual data collection has increased in size and breadth and has become one of the pillars of assessing the quality of care of patients with Diabetes in England and Wales, both in primary and secondary care. Over the years, it has grown to encompass a number of work streams including the inpatient, pregnancy, foot, insulin pump and transition from children to adult audits. It is designed to ensure that all patients diagnosed with diabetes are recorded on a register (sub divided into Type 1 and Type 2) and to measure the percentage of people receiving the nine NICE care processes, the percentage of people reaching NICE defined targets, the rate of acute and long term complications. Its purpose is to assess local practice against NICE guidance, identify shortfalls in practice that are priorities for improvement and compare an areas servicewith local peers. The data for the 2015/ 2016 audit allows analysis down to CCG and practice level, comparing results to the previous year’s iteration.  Several facts have emerged from this year’s audit. Encouragingly, participation has increased to 82.4% from 57.3% in 2014/15. The progressive rise in patients offered structured education continues to increase despite inconsistent recording of attendance. There continues to be a large variation among CCGs and local health boards, specialist and GP services for T1 and T2 diabetes, a situation not explained by case mix and with patients aged <65 performing worst. A drop in BMI and urinary albumin/ creatinine ratio measurements from earlier audits have not recovered. Encouragingly people with learning difficulties have similar care processes and target results compared to people without learning difficulties.

Clearly reducing the significant variability in care that exists should be the one of the main action points but other recommendations include attempts to improve the access to and recording of structured education attendance and in particular addressing the age related quality issues that have emerged. Allowing patients access to their practice results would also go some way in empowering them to address individual care issues.

Dr. Mark Freeman

The financial problems facing the NHS have been well documented especially at a time of rising demand from an ageing population with multiple comorbidities including diabetes, the epidemiology of which is well known. The national diabetes and care programme, linked to the sustainability and transformation plans seeks to direct funding towards elements of diabetes care which will improve outcomes. Bids from CCGs or groups of CCGs are invited for funding to develop a number of work streams. Specifically, improving the uptake of structured education by the newly diagnosed. Uptake for this is only 5.7% and, given the evidence to support its effectiveness in promoting glycaemic control there is potential that cost savings will offset the increased availability. Improving the achievement of the NICE recommended targets for HbA1c, cholesterol and BP and driving down variation across different CCGs is another area to be funded. Clearly the impact of improving these parameters on long term complications has a powerful evidence base but the national diabetes audit does show a significant degree of variation across the country not just explained by differences between the populations. Reducing amputations by improving the timeliness of referrals from primary care to a multi-disciplinary foot team will also be funded. Given the significant morbidity and mortality associated with this implication, reducing frequency and severity of ulceration will reduce hospital admissions and the  long term costs of amputations. Cost savings will significantly exceed the cost of putting multidisciplinary foot care teams in place. The fourth funding stream is to increase the provision of diabetes in patient specialist nurses. This revolves around the evidence for DSNs reducing the length of stay for in patients with diabetes, again the cost of putting them in place being exceeded by savings.

As expected, the funding available does come with caveats including the link between bids and STPs and that it is available for 2017/18 and provisionally for 2018/19. There is also a complex framework to follow during the process. Whilst any extra funding for diabetes is welcome, there is the potential to fragment services further depending on the success of these bids.

Dr Mark Freeman

2016 has seen the publication of two large type 2 diabetes (T2DM) cardiovascular safety outcome trials (CVOTs) which showed benefit of glucagon-like receptor-1 agonists (GLP-1RAs). The LEADER study compared once-daily liraglutide with placebo in over 9,000 patients treated for a median of 3.8 years and showed statistically significant superiority in the primary end-point of a composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke. The SUSTAIN 6 study was a smaller (3,297 patients), shorter (104 weeks) pre-license analysis of once-weekly semaglutide versus placebo. Using the same primary end-point, it demonstrated superiority, albeit in an analysis which was not pre-specified; for this reason, a further much larger CVOT of injected semaglutide is anticipated.

GLP-1RAs are currently administered by subcutaneous injection and, although this is a very simple procedure, it does act as a barrier to their early inclusion in therapy algorithms. Indeed, in the NICE T2DM guideline, published in December 2015, this class of anti-diabetes therapy is restricted to the pre-insulin segment and only after failure of triple oral therapy. However, there is rapid progress being reported in this field. In December 2016, vTv Therapeutics Inc. announced positive data from a phase 2 study evaluating TTP273, an oral small molecule GLP-1RA. TTP273 demonstrated a statistically significant reduction in HbA1c with negligible incidence of nausea and vomiting, the most common side-effects of GLP-1RA administration. A trend towards weight loss was also observed.

The development of an oral version of semaglutide is even more advanced. This once-daily GLP-1RA is currently going through an extensive phase 3 programme, having demonstrated impressive reductions of both HbA1c (of almost 2.0%) and weight (up to 6.5Kg) in the phase 2 trials. The pre-license CVOT of oral semaglutide, known as PIONEER 6 is due to recruit its first patients in January 2017.

So, there is the prospect of oral GLP-1RAs, with superior CV profiles to established anti-diabetes therapies. And these follow-on from the results of the EMPA-REG OUTCOME study which showed CV superiority of oral empagliflozin over placebo, once again using the primary end-point used in LEADER and SUSTAIN 6. Moreover, this sodium-glucose 2 transporter (SGLT2) inhibitor also dramatically reduced heart failure admissions, something not seen with GLP-1RAs. A caveat for all three studies is that only patients at extremely high-risk of CV disease were included and so their generalisablity to all patients with T2DM has yet to be demonstrated. More studies, currently on-going, will help address this question (e.g. the CANVAS study of canagliflozin, due to publish in 2017).

The EMPA-REG OUTCOME data has, however, led the FDA to approve a new indication for empagliflozin ‘to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease’. The 2017 American Diabetes Association Guidelines will include a new recommendation ‘to consider the use of empagliflozin in people with type 2 diabetes and established cardiovascular disease to reduce the risk of cardiovascular death’. And other national guidelines, such as those of the Canadian Diabetes Association, have already made changes based on these data.

The question remains as to how these developments will be integrated into guidance in the UK. The 2015 NICE update came over six years after its previous iteration and it almost didn’t include any reference to the SGLT inhibitors, despite the first of them being licensed for use in the EU in 2012. The full guideline assessment by NICE is clearly too slow, something acknowledged by the agency when Clinical Guideline 28 was launched, however, the process for early updating has not been disclosed. The therapy landscape is rapidly changing and this issue needs to be addressed.

Professor Steve Bain

In 2015, Public Health England commissioned four sets of questions on NatCen’s British Social Attitudes (BSA) survey, one of which focused on obesity. The BSA is an authoritative, high quality source of data on views of the British public which has been performed annually since 1983. It uses random probability sampling to yield a representative sample of adults aged 18 years and older who live in private households. The majority of questions are asked by an interviewer face-to-face in the form of a Computer Assisted Personal Interview, while a smaller number are answered by respondents in a self-completion booklet.

“Attitudes to obesity” is the publication of the obesity findings from the 2015 survey, presenting new findings on attitudes towards obesity and what might be done to reduce its prevalence. Despite appreciating some of the health risks, people tended not to recognise obesity when present, especially in men. Obesity was typically regarded as a problem for individuals and health care professionals rather than society in general. Furthermore, those who are obese were often stigmatised.

The findings are particularly relevant to type 2 diabetes (T2DM) since obesity is widely seen as the driver behind the T2DM ‘epidemic’. Regarding obesity as individual issue, implies that people are personally responsible for their plight and this is then extrapolated to blame following a diagnosis of T2DM. In this environment, the political imperative to allow for new ‘expensive’ treatments to be made available to people with T2DM is low. Indeed, a new definition of ‘expensive’ comes into play, where the individual per-person drug cost is subsumed by the population cost because of the large numbers involved. On this basis, one can argue that people with T2DM are discriminated against, compared with other conditions such as cancer, heart disease and liver disorders.

Fortunately, the survey showed significant support for actions aimed at reducing levels of obesity. We need to make sure that our patients with T2DM can also tap into this support.

Professor Steve Bain