LIVERPOOL — The impressive rates of type 2 diabetes remission achieved in the DiRECT study will need more resources for training and long-term follow-up if they are to be rolled out beyond the pilot studies currently underway, warned UK clinicians at the Diabetes UK Professional Conference.
The researchers also showed data indicating that the programme, which involves rapid weight loss with a calorie-restricted liquid diet, followed by gradual food reintroduction and weight loss maintenance, may even be cost effective compared with standard care for a patient with type 2 diabetes.
The Diabetes Remission Clinical Trial (DiRECT) study involved almost 300 patients from 49 GP practices in Scotland and the North East of England, with half assigned to the intervention, known as the Counterweight-Plus programme, plus usual care, and the remainder to usual care alone.
As reported by Medscape News UK, two-year data, also presented at the meeting, demonstrated that 36% of patients attained remission of their type 2 diabetes and sustained it for 24 months.
Moreover, the degree of weight loss was important, with 64% of patients who lost at least 10kg over the study period in remission at the end of follow-up.
Discussing how to implement findings more widely, members of the study team underlined in a dedicated session at the meeting how the availability of training for more dieticians and resources for long-term follow-up will be essential if that kind of sustained weight loss is to be achieved.
Education will also play an important role, and to those ends, Diabetes UK announced the launch of a tool to help healthcare professionals talk to patients about the possibility of remission.
Remission Information Prescription
The Remission Information Prescription, which was developed by healthcare professionals, scientists and patients, adds to similar tools produced by the charity to help support patients to manage their condition and avoid complications.
Alison Barnes, a diabetes specialist dietitian at Newcastle University who is part of the DiRECT team, described the guide as “simple” and “straightforward”.
She added in a news release: “I’m very excited about the positive impact this will have.”
Efforts to make the Counterweight-Plus programme more widely available will be aided by cost-effectiveness calculations given in a poster presented at the meeting by Yiqiao Xin, Institute of Health and Wellbeing, University of Glasgow.
The study took 1-year implementation costs and outcomes for the programme from DiRECT and compared them not only with the cost of usual care in the study but also the typical annual cost of managing type 2 diabetes in the NHS.
The findings, which are also published The Lancet Diabetes and Endocrinology, indicated that the first year of delivering Counterweight-Plus, including dietitian training, could be in the region of £240 less per patient than the average annual cost to the NHS of standard care.
Speaking to Medscape Medical News, Prof Roy Taylor, professor of medicine and metabolism, Newcastle University, who co-led the DiRECT study, noted that moves to implement DiRECT in the NHS have so far been surprisingly quick.
“The movement by Public Health England has been remarkably rapid,” he said. “I can’t think of any other situation where a study has produced one year results and several pilots in different areas have been announced.”
Prof Taylor continued: “I believe, with the 2-year data, the pace will be accelerated. So I think Public Health England are responding very well so far.”
He emphasised, however, that there is a “need to see long-term support built in to the care”, adding: “For people who are in the post-diabetes state that’s so important to recognise.
“Their GPs need to be funded for 3-month visits to supervise it better and help with rescue plans, if necessary.”
Prof Taylor said: “That’s an area where we still need to press, but this is a fluid matter and I am engaged now in talking with Public Health England.
“Hopefully we’ll be able to bring this together.”
He said that the rates of remission are “something that we in the NHS and in NHS England are particularly interested in to see if we can reproduce in live environments.”
Alongside piloting the interventions from DiRECT, Prof Valabhji said that the NHS will be piloting DROPLET (Doctor Referral of Overweight People to a Low-Energy Treatment), which tested a low-energy total diet replacement programme to reduce weight in obese individuals.
He said that both studies “have shown proof of concept that this can work in randomised controlled trial settings.”
For their analysis, Yiqiao Xin and colleagues determined the set-up and running cost of the Counterweight-Plus programme, as well as the costs associated with anti-diabetic and antihypertensive medications and routine healthcare, such as primary and community care, and hospitalisations.
They focused specifically on the first year of delivering the programme and compared it with the costs accrued over the same period in the control group.
In terms of delivery, the specialist training for dieticians and practice nurses in Counterweight-Plus was £300 per practitioner. With 33 practitioners trained, that gave an overall cost of £9900.
In addition, the practice nurses and dieticians spent 16 hours each of their working time to be trained in the programme, which, at £42 per hour, cost the NHS a total of £22,176.
Annualising the overall set-up cost of £32,076 over five years, the researchers calculated that the total set-up cost per patient of the intervention in DiRECT was £48.
With the practice nurse or dietician visits, the liquid food sachets and the Counterweight-Plus booklets, the team determined that the running costs for the first year was £1175 per patient, or a total of £1223 for delivering and implementing the programme.
When the researchers compared the programme costs with routine care, they found that the intervention was associated with per patient reductions in the cost of diabetes-related GP visits of £17, as well as reductions in the cost of outpatient visits, again at £17.
There was also a reduction in non-diabetes related practice nurse visits in the intervention arm, at a mean difference per patient of £6 compared with usual care.
These were partly offset, however, by an increase in the cost of hospital admissions, at a mean relative cost increase with the intervention of £30 per patient.
The intervention was associated with significant reductions in the cost of anti-diabetes drugs, at a mean difference versus usual care of £120 per patient, as well as more modest reductions in antihypertensive drug costs, at a mean difference of £14 per patient.
The net cost for delivering the intervention and the associated routine NHS costs was therefore £1913 per patient versus £846 for controls, or an incremental cost of £1067 per patient.
When restricted to the 41.6% of patients who achieved remission with the intervention at one year over and above those in the control arm, the incremental cost of the intervention per one year of remission was £2564.
This compares with a current annual disease management cost to the NHS for type 2 diabetes of £2801.
The researchers therefore conclude: “With multiple medical gains expected, as well as immediate social benefits for patients, there is a case for shifting resources within diabetes care budgets to offer to support to patients to attempt remission.”
Not Just About Low-Calorie Diet
During the session on making DiRECT a reality in clinical practice, Louise McCombie, a dietitian and research associate, University of Glasgow, said that the headlines around the DiRECT typically focus on the low-calorie diet used at the start of the intervention.
However, she highlighted that that makes up only a small proportion of the entire Counterweight-Plus intervention, which lasts for 2 years and is highly dependent on practitioner support.
She said that implementation not only relies on the training of dieticians and practice nurses by specialist dieticians but also requires ongoing mentoring and feedback, as well as access to specialist physicians.
There is a significant time commitment required from practitioners, with patients having fortnightly appointments during the total diet replacement and food replacement phases and four-weekly appointments during weight loss maintenance.
During each phase of the intervention, from initial screening for suitability right through to weight loss maintenance, the care delivered to patients is highly individualised, with regular progress update and the setting of expectations.
Louise McCrombie said that, to minimise weight gain and help patients adopt a “new normality,” practitioners need to develop skills to help achieve long term change from the outset, which relies on ongoing support.
She said that, together, this constitutes a “paradigm shift in the dietetic management of type 2 diabetes” that will be “welcomed” by patients who are aiming for remission.
Moreover, she underlined that DiRECT is a starting point for the “prevention agenda,” which will involve continuous learning and improvements to build on its foundation.
In a second presentation, Wilma Leslie, a research nurse also at the University of Glasgow, looked at feedback the DiRECT team had received from GPs on the implementation of DiRECT.
She said that, prior to implementation, GPs had not been without concerns, particularly over the withdrawal of antidiabetic and antihypertensive medications prior to starting the total diet replacement.
In addition, practices had expressed concerns over the potential time and resource burden of DiRECT, especially as not all practices had dieticians available, and scepticism over the formula low energy diet that was used.
When the researchers surveyed a sample of GPs from the 23 that were assigned to the structured weight management programme, they found that the 10 respondents were, universally, extremely satisfied with their participation in DiRECT.
GPs did not find it particularly challenging to fit the intervention into their routine practice, and most practices found its implementation to be extremely easy.
As it turned out, the stopping of antidiabetic and antihypertensive medication was not challenging to any great degree, and GPs on average rated the effort required to keep patients in the programme as expected.
In their comments, the GPs emphasised the importance of dietetic support in managing the impact of the programme on practice workload.
The intervention also led to changes in how GPs managed their other patients with type 2 diabetes, putting more focus on early lifestyle changes and encouraging weight loss early on.
For the future, the GPs said that they will require greater provision of dietetic input in the community and more resources for all phases of the intervention, and would like to perform therapeutic trials of medication withdrawal before enrolling patients.
In the post-presentation discussion, Louise McCrombie said that a practitioner in DiRECT typically dealt with between 5 and 10 patients in each practice.
She added, however, that there is “an enthusiasm around instead…diabetes remission hubs so that, for the person referred into a specialist service, that could be provided by a dietitian.”
She pointed out that, the problem with small numbers in primary care is that practices are very busy and “the Quality and Outcomes Framework still doesn’t recognise weight plans as something that should be remunerated, so there are challenges around fitting it into practice.”
When asked about the possibly of delivering DiRECT to groups of patients, rather than singly, Louise McCrombie emphasised that it can be “highly positive as long as the group selection and the group management is appropriate.”
In addition, she underlined that, while there has been a great deal of interest in digital support apps to help with weight loss management, she was “not sure what the evidence is to say whether they’re successful or not.”
A more difficult issue, at least in some parts of the UK, is having adequate finances to fund the education of dieticians in the Counterweight-Plus programme.
Louise McCrombie said that, in Scotland, there was “enthusiasm…around refocusing dietetic resource into this very exciting study and that has resulted in quite significant funding from the Scottish Government to give more support for people undertaking such programmes”.
However, session co-chair Dr Raquel Delgado, diabetes GP lead at Hounslow Clinical Commissioning Group (CCG) Clinical Diabetes Network in London, said that the approach would be different in England.
She explained that, to secure funding in her area, “you’re probably looking at CCGs commissioning a provider to deliver that education to primary care and the community dieticians.”
She added: “I don’t know where else the funding will come from, unless it comes from Health Education England and they can provide some?”
Finally, a largely unrecognised area for patients embarking on programmes such as Counterweight-Plus, but one that can be critical in their participation, is that of their family and social network.
Joseph McSorley, who was on the DiRECT trial, said that, outside of the practice staff, he looked to his family and knowledgeable friends and contacts, such as personal trainers, to provide encouragement and advice.
At that point, Prof Taylor got up out of the audience to underline that “the input and position of the spouse is absolutely critical.”
He added: “Throughout all the work, it’s been necessary to get people to engage their spouse, their friends, their significant others in the decision of whether or not to do this.”
Prof Taylor noted: “We have to recognise this, and certainly forewarn the spouses about it because it’s something that has to be battled through.”
“It’s well worthwhile but this is an aspect of weight management that perhaps hasn’t received enough attention.”
DiRECT is funded by Diabetes UK as a Strategic Research Initiative, with support in kind from Cambridge Weight Plan. The current economic analysis was funded by a separate Project Grant from Diabetes UK.
Michael E. J. Lean reports personal fees from Counterweight Ltd, paid to the University of Glasgow, for medical advisory consultancy, and advisory board and speaking fees from Novo Nordisk. Andrew Briggs reports personal fees for consultancies from Novo Nordisk, Bristol-Myers Squibb, and GSK. All other authors declare no competing interests.
Diabetes UK Professional Conference: P185 and DiRECT: Making it a reality. Presented 6 March.
Lancet Diabetes Endocrinol 2019; 7: 169–172. Paper.