MAKING REMISSION A REALITY: THE LATEST - FEATURE DIRECT TRIAL - Diabetes UK
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FEATURE
DIRECT TRIAL
MAKING REMISSION
A REALITY: THE LATEST
PHOTO: DIABETES UK
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FEATURE
DIRECT TRIAL
Just a few months after NHS England and Scotland revealed plans to
pilot Type 2 diabetes remission services, Dr Emily Burns, Research
Communications Manager at Diabetes UK, takes a look at just how
far we’ve come since the first DiRECT results in December 2017
Earlier results from 36% liver fat to 2%, as shown diabetes who already have a healthy
In Update this time last year, we in the figure. weight. Participants will be asked to
reported on the first-year results of the Despite this fat loss, only 45.6% consume 800 calories a day (from
landmark Diabetes Remission Clinical of the participants were able to achieve soups, shakes and non-starchy
Trial. DiRECT is looking at whether remission. Prof Taylor decided to study vegetables) for up to two weeks, while
Type 2 diabetes can be put into a subgroup of people taking part in being supervised by a medical team.
long-term remission using a structured DiRECT to see if there were any After this, they’ll be supported to
low-calorie diet weight management differences in metabolism or pancreas gradually return to eating normal food
programme, delivered through NHS function of the people who achieved and to keep off the weight they lost.
primary care. Professors Mike Lean, remission after 12 months, or They’ll be asked to repeat this cycle
from the University of Glasgow, and ‘responders’ (n=29) compared to of a low-calorie diet and weight loss
Roy Taylor, from the University of those who didn’t achieve remission, maintenance up to three times. After
Newcastle, showed that almost half or ‘non-responders’ (n=16). each cycle, the research team will
(45.6%) of those taking part in the Prof Taylor and his team found measure the amount of fat in the
programme were in remission after that the biggest difference between pancreas and liver, and establish at
12 months1. Remission was defined as the two groups of people lay within which point people may achieve Type 2
having an HbA1c of less than 48mmol/ their beta cells. After losing significant remission. This can give a greater insight
mol at 12 months, with at least two weight, the beta cells of people in into the biology behind Type 2 diabetes,
months without any Type 2 diabetes remission ‘rebooted’, and started and why it may develop in people
medication. to release the right amount of insulin who aren’t overweight.
The world had the first robust the body needs2. They even gradually
evidence that significantly restricting improved over time. There was no Counting the costs
calories, to lose around 15kg, followed change in the amount of insulin being Alongside understanding whether a
by long-term support from a healthcare made by the non-responders – their programme like DiRECT could help
professional to help keep the weight beta cells had not survived the stress people achieve remission of their Type 2
off, could result in the remission of of being surrounded by internal fat. diabetes, we need to know whether it’s
Type 2 diabetes. We’re still trying to work out why this economically feasible to deliver. We
is the case. One difference between the committed a further £300,000 towards
The biology of remission two groups is that responders had lived DiRECT so that participants could be
The chances of remission were closely with Type 2 diabetes for slightly less time followed for a further three years, and
linked to weight loss: nearly nine in 10 compared to non-responders (average to evaluate the cost-effectiveness
people were in remission if they lost of 2.7 years vs 3.8 years). But both of the programme.
15kg or more. This significant weight groups lost a similar amount of weight, Led by Prof Lean and a team of
loss resulted in a drop in fat in both the which in turn was linked to a similar health economists at the University of
liver and pancreas. One participant went reduction in levels of fat in the liver Glasgow, the analysis published in the
and pancreas. Lancet Diabetes and Endocrinology
100%
36% liver fat Overall, these findings add evidence found that a Type 2 diabetes remission
to the theory that shedding liver and programme in the NHS could cost
pancreas fat is a vital part of how to put around £1,067 per participant in its
Type 2 diabetes into remission. But this first year – or, factoring in the likelihood
research suggests it’s only effective if the of success, £2,564 for each case
beta cells can be ‘rebooted’ as a result of remission3.
of that weight loss. The team compared the treatment
costs of the two groups in DiRECT:
Unanswered questions those on the weight loss programme
Aside from understanding how remission (the intervention group), and those
2% liver fat works, there are still lots of unanswered receiving current standard NHS care
questions. Firstly, we want to find (the control group). They took into
an approach that works for as many account the cost of healthcare
people as possible. That includes people professional training, providing
of different ethnicities and people the low-calorie formula diet, review
who aren’t overweight. appointments with healthcare
Diabetes UK is funding Prof Taylor’s professionals and supporting literature.
ReTUNE study, safely testing a low- The team also factored in the costs of
0%
calorie diet in people with Type 2 any routine healthcare during the 12
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Being part of DiRECT
Lesley Slaughter is a community The person that stands out to participants. One programme isn’t
dietitian in Stirling, and is one me is my very first DiRECT patient, going to fit everyone, despite how
of the healthcare professionals who achieved a HbA1c of less than desperately you want it to work
involved in DiRECT. She has 48mmol/mol after 12 weeks, and for them.
helped many participants through was in remission at one year. He is For the people taking part,
the study, from introducing the still in remission nearly four years there’s also that fear of the
low-calorie soups and shakes, later. The impact this has had on unknown about the programme.
through to providing support to his life is incredible. Anyone who You would sometimes hear they’d
re-introduce normal food and, achieves remission after years been told it was just a fad and
importantly, maintain weight loss. of taking prescribed medications were being put off taking part.
“I approached DiRECT with the is amazing. But when more DiRECT results
same apprehension and caution are published, I hope that
as any other dietitian would. This
is something which, until then,
The success of feedback will disappear.
The success of DiRECT has
I would never have recommended DiRECT has to be, to be, in part, due to the level of
to my patients, never mind deliver in part, due to the support people received during
it. But part of what I really enjoy
about dietetics is that our practice level of support the programme. The total diet
replacement is only one piece of
is constantly changing as new people received the jigsaw – the change in behaviour
research is published. So to be and habits takes a long time.
involved in a piece of research In my experience, the participants The learning for me has
like this was exciting. who are most successful at staying been absolutely huge and I feel
It was all brand new – for me in remission are those who are fortunate to have had the research
and for the people coming along. monitoring. So weighing themselves team on hand. They’ve been an
There was a mixture of emotions frequently, continuing to monitor incredible support. I think that
PHOTO: ADOBE STOCK
– nerves, excitement, caution, their dietary intake using a diary or learning with practitioners could
determination. They might be an app. Reintroducing healthy food be shared, so when thinking
thinking, “How will this be is difficult – that idea of handing about delivering something like
different to things I’ve tried in the back control on food choices this in the future, there’s a pool
past? Will I be able to do this?” was a bit overwhelming for some of us willing to share.”
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FEATURE
DiRECT TRIAL
months, including primary care, costs of new, promising, remission healthy blood glucose levels lead to a
community care, hospitalisations, and interventions like DiRECT. The second- lower risk of diabetes complications.
anti-diabetes and anti-hypertensive year results of the DiRECT study are • We know that remission isn’t possible
medications. eagerly anticipated, as the case for for everyone. But if you’re overweight,
The cost of the 12-month remission-centred Type 2 diabetes there are real benefits to losing weight.
programme, allowing for savings for care as an option for some individuals Fewer medications, and lower blood
reduced drug and medical needs, was depends upon a thorough pressure, blood glucose levels and
£1,067. By the end of the first 12 understanding of the longer-term cholesterol: all risk factors for diabetes
months of the DiRECT study, 46% of benefits. complications.
participants were in remission. Taking “If people can remain in remission, • We recommend that people with
this likelihood of achieving remission into and therefore reduce their risk of Type 2 diabetes maintain a healthy
account, the team estimated that each developing serious diabetes-related weight through regular physical activity
case of remission would cost £2,564. complications in the future, the cost and a balanced diet. This means
The most recent, comprehensive savings to the NHS could be significant. choosing less red or processed meat,
analysis in 20104, cited the cost of Costs aside, remission from Type 2 – and more fruit and vegetables,
treating and managing Type 2 diabetes and the possibility of living free of the wholegrains, fish, pulses and nuts.
across the whole UK population – condition – has to be the preferred • We recommend that people who are
coincidentally – at £2,564 (£2,810 if option for people and clinicians alike.” in remission still attend their annual
allowing for inflation). However, it is Bridget Turner, Director of Policy and health checks, to check that their
important to note that this figure Campaigns at Diabetes UK, said: “The Type 2 diabetes hasn’t returned
includes the treatment of serious first-year results of DiRECT were very and they haven’t developed
complications and covers all stages encouraging and, while we don’t any complications.
of Type 2 diabetes throughout a yet have all the answers, this
person’s lifetime, which this new economic study, and its findings,
analysis does not. are particularly timely.
The DiRECT remission programme, “We’re delighted that, thanks to a
delivered within NHS primary care, growing body of evidence – including
is therefore relatively inexpensive when that from DiRECT – NHS England and REFERENCES:
compared with the serious and Scotland have committed to exploring 1 Lean ME, Leslie WS, Barnes AC et
expensive complications of Type 2 the potential of intensive lifestyle al (2018). Primary care-led weight
diabetes, which remission might avoid. interventions as an option which may management for remission of
As we continue the study we will learn lead to remission for more people with Type 2 diabetes (DiRECT): an
more about the balance of financial Type 2 diabetes near to diagnosis. open-label cluster-randomised
costs and benefits for this approach. “We hope this economic analysis trial. The Lancet 391 (10120),
These findings support the case will help to inform the set-up and 541–551. https://doi.org/10.1016/
for considering weight reduction delivery of more pilots – with appropriate S0140-6736(17)33102-1.
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for some people to put their Type 2 the future.” Zhyzhneuskaya S et al (2018).
diabetes into remission. remission of human Type 2
Professor Andrew Briggs, Health Advice for you in diabetes requires decrease in liver
Economist at the University of Glasgow, the clinic and pancreas fat content but is
explains: “This intervention is relatively Do you see patients who have put their dependent upon capacity for beta
inexpensive when compared to Type 2 diabetes into remission? Or cell recovery. Cell Metabolism 28
managing Type 2 diabetes, and we perhaps people who would like to? (4),547-556.e3. https://
anticipate that there will be cost savings Last year’s news from NHS England doi:10.1016/j.cmet.2018.07.003
further down the line. If people can stay and Scotland, who have both 3 Xin Y, Davies A, McCombie L et al
in remission and therefore reduce their committed to piloting remission (2018). Within-trial cost and 1-year
chances of developing diabetes programmes, is exciting. But what cost-effectiveness of the DiRECT/
complications, the cost savings to happens in the meantime? Diabetes Counterweight-Plus weight-
the NHS could be substantial. UK has developed an Information management programme to
“We can’t know this for certain yet. Prescription, together with healthcare achieve remission of type 2
Which is why the long-term follow-up professionals and people with Type 2 diabetes. The Lancet Diabetes &
of these participants – alongside those diabetes, to support you to have Endocrinology pii: S2213-8587(18),
accessing any NHS remission pilots conversations with your patients about 30346-2. doi: 10.1016/S2213-
in the near future – is very important. what remission really means. Alongside 8587(18)30346-2
However, these findings are encouraging, this, here are Diabetes UK’s top [Epub ahead of print]
and – in our view – begin to make messages: 4 Hex N, Bartlett C, Wright D et al
the case for shifting resources to offer • Remission is when a person with (2012) Estimating the current and
remission-based models of care Type 2 diabetes has healthy blood future costs of type 1 and type 2
in the future.” glucose levels for the long term, diabetes in the UK, including
Dr Elizabeth Robertson, Director without any diabetes medications. direct health costs and indirect
of Research at Diabetes UK, said: “It is • Remission can be life-changing. societal and productivity costs.
critical that we understand the real world No more diabetes medications, and Diabetic Medicine 29 (7), 855–862
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