Dr Pam Brown provides seven key learning points for primary care from a consensus report on defining remission in diabetes
Read this article to learn more about:
- the definition and nature of remission in diabetes
- possible interventions and pathways that can achieve reversal of diabetes
- the benefits of pursuing and maintaining diabetes remission.
Read this article online at: GinP.co.uk/456683.article
Test and reflect multiple-choice questions on this topic are available on p.XX and online at: GinP.co.uk/XXXXXX.article
Type 2 diabetes is a major public health epidemic;1 rates of type 2 diabetes continue to rise across the UK and globally, and the personal and financial costs of the disease are huge.2 Studies attempting to demonstrate the feasibility of reducing blood glucose to the point where the criteria for a diagnosis of type 2 diabetes are no longer met have used a wide variety of nomenclature, including ‘cure’,3 ‘remission’,3 ‘reversal’,1 ‘resolution’,1 and ‘mitigation’.4 The glucose thresholds used to define this state vary between different countries and organisations,3,5 which can cause confusion and uncertainty as to whether people with type 2 diabetes have achieved a glucose level low enough, and for long enough, to qualify as ‘in remission’. A 2020 systematic scoping review6 identified 96 unique definitions of diabetes remission used since 2009, further highlighting the need for clarity. Examples of the two most commonly used definitions for diabetes remission are shown in Box 1.3,5
Box 1: Common definitions of diabetes remission3,5
In 2009, a consensus group of experts from the ADA defined diabetes remission as follows (with the patient no longer taking glucose-lowering medications in each case):3
- complete remission: HbA1c in the normal range and FPG <100 mg/dl (<5.6 mmol/l) for at least 1 year
- partial remission: HbA1c <6.5% (48 mmol/mol) or FPG 100–125 mg/dl (5.6–6.9 mmol/l) for at least 1 year
- prolonged remission: complete remission for at least 5 years.
The 2019 PCDS/ABCD position statement on remission included the following three criteria:5
- weight loss
- FPG <7 mmol/l or HbA1c <48 mmol/mol on two occasions separated by at least 6 months
- complete cessation of all glucose-lowering treatments.
ADA=American Diabetes Association; HbA1c =glycated haemoglobin; FPG=fasting plasma glucose; PCDS=Primary Care Diabetes Society; ABCD=Association of British Clinical Diabetologists
The joint Primary Care Diabetes Society (PCDS) and Association of British Clinical Diabetologists (ABCD) position statement describes diabetes remission as an achievable outcome in people with type 2 diabetes, and highlights the central role of weight loss and need for ongoing support to maintain remission.5 The Diabetes REmission Clinical Trial (DiRECT) study sought to clarify the weight loss needed to achieve remission of type 2 diabetes, proposing a weight loss goal of 15 kg.7 However, diabetes remission is not a specified goal in current clinical guidelines and management algorithms, which may reflect the lack of consensus on an agreed definition. The 2021 Consensus report: definition and interpretation of remission in type 2 diabetes8 collates the summary and conclusions of discussions between an international, multidisciplinary group, including representatives from the American Diabetes Association, the European Association for the Study of Diabetes, Diabetes UK, the Endocrine Society, the Diabetes Surgery Summit, and an oncologist. The authors stress that the report is based on expert opinion, and is designed to propose definitions and ways to assess glycaemia that facilitate the collection and analysis of data that may, in future, lead to clinical guidance.8 It is not intended to establish treatment guidelines, recommend when to pursue remission, or favour any specific intervention for achieving remission.8
This article will explore the implications of this consensus report for UK primary care, and share seven key actions around remission of diabetes.
1. Start to use the new consensus definition of remission
The consensus report agrees with previous guidance that ‘remission’—a word commonly used in cancer treatment—is the appropriate term, rather than ‘cure’, ‘resolution’, or ‘reversal’, because the improvement may not be permanent, and ongoing monitoring and support is required to reduce the risk of relapse.8
According to the consensus report, the recommended definition of remission is now:8
- glycated haemoglobin (HbA1c) less than 48 mmol/mol (less than 6.5%), measured by a standardised and quality-assured method when no longer taking any glucose-lowering medication
- maintenance of this HbA1c level for at least 3 months after discontinuation of any glucose-lowering medication.
Notably, this definition of remission requires HbA1c to be less than 48 mmol/l for a shorter duration than the 6 months advocated by the previous PCDS/ABCD position statement used in the UK.5,8 Therefore, it may be the case that more people currently living with diabetes will now meet the definition, and can be coded accordingly.
Determining remission when HbA1c is an unreliable measure
In some people, HbA1c can be influenced by factors that make it unsuitable for diagnosing remission of type 2 diabetes, including variant haemoglobin, differing glycation rates, and alterations to the survival of erythrocytes.8 Local laboratories will be able to provide advice on when it is best to use an indicator other than HbA1c for diagnosis and monitoring. In these cases, continuous glucose monitoring (CGM) can be used to measure mean 24-hour glucose levels, and from this an HbA1c equivalent to the mean glucose, called an ‘estimated HbA1c’ or ‘glucose management indicator’, can be calculated.8 If this is less than 6.5% (48 mmol/mol), it can be used to confirm remission.8 This technique will usually require assistance from secondary care.
A fasting plasma glucose (FPG) level of less than 7 mmol/l can also be used to confirm remission if other methods are unsuitable,8 but use of the plasma glucose level 2 hours after a 75-g oral glucose challenge is not recommended by the consensus report because bariatric surgery may alter response to glucose load.8
Given that FPG and CGM readings change more rapidly than HbA1c, it is not necessary to wait 3 months after treatment is discontinued to check for remission but, because these readings are more variable, the report recommends that testing should be repeated to confirm remission or relapse.8
Cessation of pharmacotherapy before testing
All drug therapy with specific effects on glucose lowering should have been stopped for at least 3 months before the biochemical test to confirm remission, irrespective of whether the drug was being used for type 2 diabetes or for other reasons (for example, use of glucagon-like peptide-1 receptor agonists for weight loss).8 This ensures that any effects on HbA1c have dissipated, and that the retrospective measurement period (about 12 weeks) has been free of drug treatment.8 Lifestyle and behaviour changes aimed at weight loss and maintenance should continue. In addition, weight-loss drugs, which may have indirect effects on improving glucose levels via weight loss, can be continued in the 3 months preceding biochemical testing.8
Intervals between HbA1c tests
The consensus report sets out the initial interval before HbA1c tests can confirm remission, as shown in Table 1.8 Once remission has been confirmed, testing should be repeated after at least 3 months—and at least at 12-monthly intervals thereafter to detect ongoing remission or relapse to type 2 diabetes.8
|Intervention[A]||Interval required before testing of HbA1c can reliably evaluate the response||Subsequent measurements of HbA1c to document continuation of remission|
At least 3 months after cessation of any pharmacotherapy
No more often than every 3 months, and at least annually
At least 3 months after the procedure and 3 months after cessation of any pharmacotherapy
At least 6 months after beginning the intervention and 3 months after cessation of any pharmacotherapy
[A] Note: Documentation of remission should include a measurement of HbA1c just before intervention
|HbA1c =glycated haemoglobin|
Adapted with permission from Riddle M, Cefalu W, Evans P et al. Consensus report: definition and interpretation of remission in type 2 diabetes. Diabetes Care 2021; 44 (10): 2438–2444.
2. Discuss remission with patients in diabetes consultations
Now that there is a growing evidence base that type 2 diabetes remission is achievable with significant weight loss of 10–15 kg, we owe it to people living with diabetes to discuss remission as a management option, particularly in the first 6 years or so after diagnosis, and in people who are not yet taking insulin. Although the DiRECT study and NHS remission pilots restricted recruitment to those who were diagnosed in the previous 6 years,7,9 other studies have shown that people who have lived longer with type 2 diabetes and those who are on insulin can still achieve remission.10,11
When discussing remission, it is important to know whether a remission pilot or service is available in your local area and, if not, how to access weight-management services that can help support patients to achieve the significant weight loss needed for remission. A leaflet that summarises the dietary options and weight-loss targets that may achieve type 2 diabetes remission will assist with informed decision making around remission (for an example, see bit.ly/3qP0Phw). If your practice is in a remission pilot site catchment area, you will have the opportunity to participate in training to help optimise these conversations and support people to decide if remission is something they wish to pursue.
Not everyone will want to actively pursue remission, but everyone with type 2 diabetes (particularly those with a recent diagnosis) should know enough about remission to make an informed choice.
3. Learn about different routes to remission
Professor Roy Taylor emphasises that anyone developing type 2 diabetes has exceeded their ‘personal fat threshold’;12 that is, they are storing more fat than their personal fat stores can accommodate, causing fat from diet and liver manufacture to accumulate at ectopic sites, including the muscles, liver, and pancreas, and resulting in lipotoxicity, insulin resistance, and damage to pancreatic beta cells. In many individuals, weight loss can help to achieve remission,12 particularly in the early years of type 2 diabetes. Even unintentional weight loss, as is commonly seen in frail elderly individuals, can result in remission. It is important to identify remission, so that medication can be stopped or optimised.4
To achieve the significant weight loss required to attain remission, more intensive dietary or lifestyle changes are required than those needed to achieve small amounts of weight loss. In the DiRECT study,7 46% of the intervention group overall, and 86% of those achieving the target weight loss of 15 kg or more, achieved remission at 12 months. The intervention itself consisted of:
- withdrawal of antidiabetic and antihypertensive drugs
- 3–5 months of total diet replacement (TDR), consisting of approximately 850 calories per day
- food reintroduction and ongoing support to 12 months.
In contrast, the LookAHEAD study used a more moderate calorific reduction to 1200–1800 calories per day using a low-fat, relatively high-carbohydrate diet. In this study, overall, only 11.5% achieved either partial or complete remission by US definitions at 1 year, with rates of up to 21% among those who achieved significant weight loss.13
Low- or very-low-carbohydrate diets may induce weight loss, but are also thought to aid people in achieving remission levels of glycaemia by providing a much decreased glucose load.4 Some authors have therefore suggested that reduced glycaemia without weight loss should be termed ‘type 2 diabetes mitigation’ rather than remission,4 because the improvements may be dependent on continuation of the restricted diet.
It is important to individualise dietary discussions, as no one diet will suit everyone. Remission maintenance will depend on helping people to choose a realistic dietary approach. The same lifestyle changes that aid weight loss and remission will be beneficial for type 2 diabetes and other chronic health conditions,4 so even if remission is not achieved, it is possible that a number of other outcomes would still be worth the effort—for example:
- reduction in glucose-lowering medication
- tighter glycaemic control
- improved symptoms
- possible reduced risks of cardiovascular disease, obesity, and cancer.
Increasing physical activity is not a prerequisite for remission and, in the TDR phase of the DiRECT study, participants were encouraged not to change or increase their activity.7 However, physical activity can counteract insulin resistance, and will aid weight maintenance in the longer term.14
The evidence base for interventions supporting remission in people with type 2 diabetes is expanding; see Box 2 for a brief summary of the interventions.1,7,11,15–25
Box 2: Interventions with evidence for type 2 diabetes remission1,7,11,15–25
Low-calorie diet and TDR
In a low-calorie diet TDR phase, commercially available complete meal replacement soups and shakes (or home-made soups or porridge), providing around 850 calories per day, replace all meals for 3–5 months.7
TDR should be followed with stepped food reintroduction and ongoing support to maintain lower weight;7 remission correlates with weight loss achieved.7 Similar programmes are available from commercial weight-loss organisations (for example, Cambridge, Lighter Life, and Counterweight Plus), but people with type 2 diabetes on medication need support from primary or secondary care to decrease medications.
Low-carbohydrate and very low-carbohydrate-diets
Restricted-carbohydrate diets are now included in the ADA and Diabetes UK dietary guidelines for the prevention and management of type 2 diabetes.15,16 A recent systematic review and meta-analysis, which included some unpublished data, demonstrated that low-carbohydrate diets (<26% calories as carbohydrate, <130 g carbohydrate per day) or very low-carbohydrate diets (<10% of calories as carbohydrate, <50 g carbohydrate/day) were associated with 32% remission at 6 months due to significant weight loss and improved insulin resistance.11
However, the fidelity of the diet’s carbohydrate content within the individual studies can be challenged, and the long-term sustainability of low-carbohydrate diets is uncertain. Carbohydrate restriction may reduce glycaemia into the remission range by decreasing glucose load.1
Unprocessed, whole-food, largely plant-based diet
Significant weight loss can be achieved by reducing the amount of energy-dense food eaten, or, alternatively, the energy density of foods in the diet which allows greater volumes to be eaten.17 A diet of low-energy density, unprocessed whole foods such as fruits, vegetables, wholegrains, and legumes, combined with greatly reduced amounts—or an absence—of energy-dense foods such as animal produce, dairy, and fats, can be satiating and low in calories.17 Such diets allow people to eat as much as they wish, thus avoiding hunger while maintaining lower calorific intake and weight.18 Weight reduction may be slower than with other methods depending on the habitual diet being replaced, but because new eating habits are established, it may be easier to maintain. Weight loss rather than diabetes remission was the primary goal in most of these studies, but the BROAD study showed that a whole-food, plant-based diet can achieve diabetes remission.19
Bariatric or metabolic surgery results in significant weight loss, and is a recognised route to type 2 diabetes remission.20 Before surgery, a very-low calorie diet is used to shrink liver fat, and make laparoscopic surgery safer. Reduced dietary intake is required immediately after surgery and, in the long term, smaller portion sizes should be used. Combined with gut remodelling, this contributes to decreased calorific intake, changes in gut hormones,20 alterations in the microbiome,20 and changes in bile acid signalling,21 and very rapid improvement in glucose levels is often achieved early after surgery, before significant weight loss.22 Remission rates at 5 years in the STAMPEDE study23 using a glycaemic threshold of <6% (42 mmol/mol) were 29% with RYGB and 23% with sleeve gastrectomy, versus 5% remission in controls.
Although the anatomical changes achieved with surgery are permanent, and ongoing weight loss and maintenance contribute to improved diabetes control or remission, relapse can still occur.23 The Swedish Obese Subjects Study reported 10-year remission rates of 36% with RYGB, down from 72% at 2 years after surgery.24 Although operative mortality is low, complications are more common (up to 21%).1,25 Bariatric and metabolic surgery are unlikely to be scalable to deliver significant levels of remission.
TDR=total diet replacement; ADA=American Diabetes Association; STAMPEDE=Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently; RYGB=Roux-en-Y gastric bypass
4. Understand when pursuing remission is not recommended
Caution is required in those with high HbA1c values because rapidly lowering their HbA1c, whether to induce remission or improve glycaemic control, may result in worsening of microvascular complications, including diabetic retinopathy.8 For this reason, the consensus report warns against trying to achieve rapid HbA1c reduction in people with retinal changes beyond microaneurysms (more than background retinopathy).8 Retinal screening should be arranged if sudden HbA1c reduction occurs in known retinopathy.8
People treated with sodium–glucose co-transporter-2 (SGLT-2) inhibitors should not follow very low-carbohydrate, ketogenic diets because these are likely to increase the risk of diabetic ketoacidosis, which is otherwise low when using these drugs.26
5. Explore your local pathway for access to remission or weight-management programmes
Remission pilot programmes using TDR are ongoing across 10 sites in England and in the other UK nations,9 although many of these have been disrupted by the pandemic (see Box 3).9,27–29 When discussing remission in our clinics, it is important that we know whether there is access to a local remission service and how this operates, if there is no remission service available and a patient wishes to pursue remission, be aware of the support that can be provided, for example, through referral to a local nutrition and dietetic department or weight-management service.
6. Review ‘type 2 diabetes in remission’ and remove ‘diabetes resolved’ coding
‘Diabetes mellitus in remission’ or ‘type 2 diabetes in remission’ codes should already be in use, and people in this population should receive a diabetes review at least annually that includes an HbA1c test to confirm that they are still in remission.8 During the COVID-19 pandemic, ensuring that people currently in remission have their HbA1c measured will have been a lower priority than managing those with significant hyperglycaemia to reduce their risks, so many people in remission are likely to be overdue for review. When there is spare capacity in practice systems, these should be scheduled.
In addition, it is important to run a search for the two ‘diabetes resolved’ codes to check that these have not been used historically, which may result in people being erroneously removed from the diabetes register and no longer considered for reviews. There may also be some overlap in coding, with some people having both a remission and a resolved code. When removing the resolved codes, take care to leave an appropriate audit trail, so that it is clear when and why this has been removed.
Discuss how to amend coding when someone previously in remission relapses again with your computer system user group and local colleagues. It is important to agree whether the person should be coded as having new type 2 diabetes, but practices are likely to want to ensure that the original diagnosis date is still clear. There is no guidance on this in the consensus report.
7. Ensure that long-term follow up continues
Weight gain, stress from daily life, other illnesses, poor sleep, drugs that cause weight gain, an inability to maintain healthy lifestyle changes, or dietary lapse (if using a low-carbohydrate diet to achieve remission) can all result in a relapse of type 2 diabetes in people who have previously achieved remission. Lifestyle changes reduce the underlying causative factors of type 2 diabetes, making longer-term remission more likely, but ongoing monitoring is still needed.8
Even if remission is maintained and relapse does not occur, the risk and progression of microvascular and macrovascular complications (retinopathy, nephropathy, neuropathy, and cardiovascular disease) may continue.8 The 2021 consensus report reminds us that there is no evidence that any of the usual diabetes assessments can safely be discontinued once people are in remission.8 Diabetic retinopathy screening must continue, as should attendance at a diabetic eye clinic for those who have previously been referred, even if remission is achieved.8 Also, annual foot checks, blood pressure and weight measurements, and assessments of renal function and HbA1c should carry on.8
The consensus report reiterates guidance from the previous ABCD/PCDS position statement that at least annual measurement of HbA1c is required for those in remission, and that systems for recall should already be in place,5,8 although it is possible that these have been disrupted during the pandemic. People who have recently achieved remission may initially prefer more frequent HbA1c checks, and these can be carried out every 3–6 months, and can be motivational in terms of encouraging weight maintenance or further weight loss. Early identification of weight regain and any impact on glycaemia may prompt remedial action, as occurred in the DiRECT study, where short courses of TDR rescue therapy and/or orlistat were available.30
The consensus report’s authors did not feel able to say whether drugs such as metformin should be used to help maintain remission and prevent relapse, but they were clear that, where drug treatment is used, ongoing or new remission cannot be confirmed.8 Treatment with SGLT-2 inhibitors for chronic stable heart failure with reduced ejection fraction or to slow progression of chronic kidney disease will have glucose-lowering effects (if the estimated glomerular filtration rate is sufficiently high).8 These provide important benefits and may be continued, but it will not be possible to confirm remission.8
What are the practical benefits of striving for remission for people with diabetes?
Receiving a diagnosis of type 2 diabetes can have a significant impact on mental health, and knowing that diabetes remission has been achieved through self-management can have a very positive effect. Even if remission is not attained, making lifestyle changes and achieving significant weight loss can have a beneficial effect on mood, physical function, and other chronic diseases. Benefits will therefore accrue for the majority of people living with type 2 diabetes.
The consensus report—and the evolving evidence base for remission and its associated benefits—should reinvigorate our efforts to routinely discuss remission, refer people who wish to pursue it to weight management and remission pathways as they become available, and support more people to achieve remission, particularly those early in the course of their type 2 diabetes journey. We can optimise our use of the resources available locally, and work closely with dietetic and weight management colleagues and our own practice teams, to actively help people achieve ‘double-digit’ weight loss to facilitate remission. In addition, the clear definition of remission in the report provides clarity for our coding and conversations.
- Remission is now defined internationally and in the UK as an HbA1c of <48 mmol/mol (<6.5%), which persists for at least 3 months after all glucose-lowering treatment has been stopped8
- If HbA1c is an unreliable marker of glucose level in an individual, then an eHbA1C of <48 mmol/mol (<6.5%) calculated from 24-hour CGM values, or an FPG of <7.0 mmol/l (126 mg/dl), can be used as alternatives; because these measurements change more rapidly, they can be measured at an earlier stage after medication is stopped, but should be repeated to confirm remission or relapse8
- Testing to confirm remission should occur at least 3 months after all medication has been stopped, at least 3 months after bariatric surgery, or 6 months after sustained lifestyle changes have been implemented8
- Remission rates correlate with weight loss, with a 15-kg weight loss goal in the DiRECT study; however, weight loss is not part of the definition of remission in the consensus report7,8
- Remission can be achieved using bariatric surgery, low-calorie diets, or low-/very-low-carbohydrate diets; because the latter may not change the underlying processes, relapse is likely if the diet lapses unless significant weight loss has already occurred
- Not everyone with type 2 diabetes will want to pursue remission, but everyone with type 2 diabetes, particularly those with a recent diagnosis, should know enough about remission to be able to make an informed choice
- Those who want to pursue remission should be offered appropriate support, ideally including access to a dietitian, and understand that remission cannot be guaranteed—but that, even if not achieved, weight loss and lifestyle changes will have health benefits
- Diabetic review, including HbA1c, renal function, BP, and weight measurements, and a foot check, should be carried out at least annually in those in remission, and retinopathy screening and hospital eye service care should continue at the recommended intervals.8
HbA1c =glycated haemoglobin; eHbA1c =estimated HbA1c; CGM=continuous glucose monitoring; FPG=fasting plasma glucose; BP=blood pressure
Box 3: Remission across the UK9,27–29
Eight percent of the Welsh population aged >16 years are currently living with diabetes (more than 209,000 people), 90% of whom have type 2 diabetes.28 An all-Wales remission pilot in 90 people with type 2 diabetes began in January 2020 to test the real-world implementation of delivering TDR within the Cardiff and Vale, Hywel Dda, Betsi Cadwaladr, and Aneurin Bevan University Health Boards, led by Catherine Washbrook-Davies, All-Wales Dietetic lead for Diabetes (Adults). The pilot mirrors the DiRECT study methods, and participants are supported for 12 months by a dietitian. Implementation was delayed due to the COVID-19 pandemic but, to date, all patients have been recruited. As of the end of March 2021, 74 patients had commenced TDR, 43 had completed food reintroduction, and 16 patients were in the weight loss-maintenance phase. HbA1c results were available for 33 people at the end of TDR: 27% (n=9) had an HbA1c <42 mmol/mol, 52% (n=17) had reduced their HbA1c to the pre-diabetes range (42–47 mmol/mol), and only 21% (n=7) were in the type 2 diabetes range. The mean weight loss for each phase so far is 12.6 kg after TDR, 15.7 kg after food reintroduction, and 17.4 kg at the end of weight maintenance (12 months; unpublished data obtained via personal communication). Further data collection is ongoing, and qualitative evaluation is being undertaken to gain insight into the patient experience of their diabetes remission journey. Funding has been made available from the All Wales Diabetes Implementation Group to roll out the programme across Wales by direct referral of appropriate patients from GP practices. Following staff and patient feedback, a menu of dietary approaches to support weight loss and diabetes remission, combined with 12-month support, should be available from January 2022.
The Scottish Diabetes Survey 2019 reported that 274,442 people were living with type 2 diabetes in Scotland,29 which equates to around 5% of the population. In 2018, the Scottish Government published a national framework for type 2 diabetes, with associated funding to support health boards with its implementation.30 One of the care pathways within this framework is the type 2 diabetes remission programme. The ambition in Scotland is to scale up a TDR programme based on the DiRECT protocol to be delivered at a national level as a 2-year intervention for people newly diagnosed with type 2 diabetes.30 The COVID-19 pandemic has affected the delivery timescale; however, all 14 territorial health boards in Scotland and one special health board, The State Hospital, have successfully established their pathway. They have recruited specialist dietitians to deliver the programme, and referral routes are in place using Counterweight Plus as a Once for Scotland intervention. The creation of a data-collection tool for type 2 diabetes prevention, remission, and weight management will allow progress of more than 100 patients already enrolled in treatment to be reported in greater detail in 2022. Simultaneously, a significant development in digital delivery of type 2 diabetes remission will begin. In collaboration with the Scottish Government’s Technology Enabled Care Team, the professional advisers on the framework are working with national expert dietetic and multiprofessional leads to co-design and co-create a remote health pathway for type 2 diabetes remission in NHS Scotland using the Inhealthcare platform. This pathway will enable self-management, self-monitoring, and asynchronous communication between patients and clinicians, supporting self-management as close to home as possible. It is hoped that the extended services and new remission pathway will improve access to remission programmes and allow other evidence-based dietetic therapies—such as low-carbohydrate diets—to be included, allowing for more individualised interventions to facilitate remission for those with type 2 diabetes.
The NHS in England launched a pilot of a low-calorie diet programme in September 2020, and recently announced a further expansion its coverage. The 12-month programme consists of 3 months of TDR followed by ongoing behavioural support.9 As of September 2021, 2200 eligible referrals had been received; of these, 73% went on to commence TDR, with a completion rate of 90%. The mean weight loss at 3 months—the end of the TDR phase—was 13.5 kg; this was maintained at 6 months (unpublished data obtained via personal communication). Eligibility criteria were based on DiRECT, adapted pragmatically for the real world. They included: age 18–65 years; duration of type 2 diabetes of ≤6 years; HbA1c of 43–87 mmol/mol on diet alone, or 48–87 mmol/mol on drug therapy; BMI of ≥27 mg/kg2 (≥25 mg/kg2 if Black, Asian, or from a minority ethnic group).9 The programme is designed to generate minimal work for general practice, and is delivered by commercial providers, with different approaches being piloted including group and one-to-one delivery.
A pilot programme run by the South Eastern Health and Social Care Trust at Ulster Hospital is underway, with 50 patients currently on a TDR programme based on the DiRECT trial. The programme is delivered via a partnership between primary and secondary care—GPs refer motivated patients electronically to Ulster Hospital, where a consultant at the Ulster Hospital Diabetes Hub is responsible for centralised medication adjustments and review while the patient is on the programme. The model is working well, and the programme has strong support from both primary and secondary care, with significant numbers of patients being appropriately referred from GPs. Feedback from patients has been captured via a recent Diabetes UK Focus Group, with positive comments including ‘It’s the best thing you will ever do’. Attendance rate for the Zoom sessions is 86%, with a dietitian responsible for operational delivery. The average age of referred patients is 47 years, and their average BMI is 43 mg/kg2. Initial weight change outcomes are extremely encouraging, with a 14% weight reduction at the end of the TDR phase (at 10 weeks) and 15% weight reduction at the end of food reintroduction (13 weeks). There are also very positive reductions in HbA1c, and positive data in relation to blood pressure reductions and liver function (unpublished data obtained via personal communication). The remission programme is seen as part of an integral prevention and remission pathway alongside the Northern Ireland Diabetes Prevention Programme. The Northern Ireland Regional Diabetes Network has a working group focusing on new models of care for a type 2 diabetes pathway, and it is hoped that there will be an agreement on remission education. Details of roll-out and availability of remission programmes across the country after March 2022 are currently uncertain.
TDR=total diet replacement; DiRECT=Diabetes REmission Clinical Trial; HbA1c =glycated haemoglobin; BMI=body mass index
Dr Pam Brown
Editor-in Chief, Diabetes and Primary Care; GP with an interest in diabetes, obesity, and lifestyle medicine; Tutor, University of Warwick/iHeed global Diabetes Diploma; Guidelines in Practice editorial advisory consultant for diabetes and obesity
I am grateful to Ashif Ali, Chirag Bakhai, Laurie Eyles, Lesley Hamilton, Lara Jackson, Brian Kennon, Harry MacMillan, Jacqueline Walker, Catherine Washbrook-Davies, and Jason White for contributing information on remission pilots and plans for the individual nations.
Useful resources for patients
- Taylor R. Life without diabetes: the definitive guide to understanding and reversing your type 2 diabetes. London: Short Books Ltd, 2019.
- Newcastle University. Reversing type 2 diabetes and ongoing remission. go.ncl.ac.uk/diabetes-reversal
Implementation actions for STPs and ICSs
written by Dr David Jenner, GP, Cullompton, Devon
The following implementation actions are designed to support STPs and ICSs with the challenges involved in implementing new guidance at a system level. Our aim is to help you to consider how to deliver improvements to healthcare within the available resources.
- Agree andadopt a local standard for ‘diabetes in remission’ based on the new consensus statement from ABCD and PCDS
- Ask GP practices to replace any ‘diabetes resolved’ codes with ‘diabetes in remission’ codes
- Ensure all patients with diabetes in remission are still offered annual checks as if they had diabetes, and remain on the register
- Explain to patients that although their diabetes is in remission their risk of developing microvascular and macrovascular complications remains higher than those who have never had diabetes
- Continue to promote active weight management for those who have achieved remission of diabetes, as relapse is likely with any subsequent significant weight gain.
STP=sustainability and transformation partnership; ICS=integrated care system; ABCD=Association of British Clinical Diabetologists; PCDS=Primary Care Diabetes Society
- Hallberg S, Gershuni V, Hazbun T, Athinarayanan S. Reversing type 2 diabetes: a narrative review of the evidence. Nutrients 2019; 11 (4): 766.
- NICE. Diabetes—type 2: how common is it? NICE Clinical Knowledge Summary. Available at: cks.nice.org.uk/topics/diabetes-type-2/background-information/prevalence/ (accessed 13 January 2022).
- Buse J, Caprio S, Cefalu W et al. How do we define cure of diabetes? Diabetes Care 2009; 32 (11): 2133–2135.
- Brown A, McArdle P, Taplin J et al. Dietary strategies for remission of type 2 diabetes: a narrative review. J Hum Nutr Diet 2021; 1–14.
- Nagi D, Hambling C, Taylor R. Remission of type 2 diabetes: a position statement from the Association of British Clinical Diabetologists (ABCD) and the Primary Care Diabetes Society (PCDS). Br J Diabetes 2019; 19 (1): 73–76.
- Captieux M, Prigge R, Wild S, Guthrie B. Defining remission of type 2 diabetes in research studies: a systematic scoping review. PLoS Med 2020; 17 (10): e1003396.
- Lean M, Leslie W, Barnes A et al. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet 2018; 391 (10120): 541–551.
- Riddle M, Cefalu W, Evans P et al. Consensus report: definition and interpretation of remission in type 2 diabetes. Diabetes Care 2021; 44 (10): 2438–2444.
- NHS England website. Low calorie diets to treat obesity and type 2 diabetes. www.england.nhs.uk/diabetes/treatment-care/low-calorie-diets/ (accessed 13 January 2022).
- Hallberg S, McKenzie A, Williams P et al. Effectiveness and safety of a novel care model for the management of type 2 diabetes at 1 year: an open-label, non-randomized, controlled study. Diabetes Ther 2018; 9 (2): 583–612.
- Goldenberg J, Day A, Brinkworth G et al. Efficacy and safety of low and very low carbohydrate diets for type 2 diabetes remission: systematic review and meta-analysis of published and unpublished randomized trial data. BMJ 2021; 372: m4743.
- Taylor R, Holman R. Normal weight individuals who develop type 2 diabetes: the personal fat threshold. Clin Sci (Lond) 2015; 128 (7): 405–410.
- Gregg E, Chen H, Wagenknecht L et al. Association of an intensive lifestyle intervention with remission of type 2 diabetes. JAMA 2012; 308 (23): 2489–2496.
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