Type 2 diabetes in adults: management

Why the committee made the recommendations

The committee discussed how continuous glucose monitoring (CGM) could potentially be useful for many people with type 2 diabetes. They were aware of examples from current practice in which adults who have insulin-treated type 2 diabetes and use intermittently scanned CGM (isCGM) have had good outcomes. Because of the additional cost associated with CGM and the large number of adults with type 2 diabetes, the committee used both the evidence and their clinical experience to decide who would gain the most benefit from using CGM.

There was evidence that intermittently scanned CGM (isCGM) was cost effective for adults with type 2 diabetes using insulin, but no evidence for populations not using insulin, so the committee agreed to restrict their recommendations to that subpopulation.

People who have recurrent or severe hypoglycaemic events were identified as one of the groups likely to benefit most from isCGM, because hypoglycaemic events were considered to be one of the most important and concerning outcomes for adults with type 2 diabetes who are using insulin. The committee decided that the number of hypoglycaemic events was a more effective indicator of someone who would benefit from isCGM than specific HbA1c target values, because target values can vary between people. The evidence also indicated minimal effects of isCGM on HbA1c values.

The committee agreed that people with impaired hypoglycaemic awareness would also benefit from isCGM. However, they did not recommend specific methods for assessing impaired hypoglycaemic awareness. This is because validated methods for assessing impaired hypoglycaemic awareness in people with type 2 diabetes (such as the GOLD or Clarke scores) are not always available in primary care.

People who use insulin and have a condition or disability that restricts their ability to self-monitor blood glucose levels should also be offered isCGM. This is because having access to isGCM means they will no longer have to rely on others to monitor their diabetes, potentially increasing their independence. For people with learning disabilities, this recommendation is in line with similar guidance for type 1 diabetes set out in the NHS RightCare Pathway, which specifies reasonable adjustments for people with a learning disability who have diabetes.

People who are advised to self-measure using capillary blood glucose monitoring more than 8 times a day should also be offered isCGM. This is in line with the funding requirements for NHS England's flash glucose monitoring: national arrangements for funding of relevant diabetes patients. Although the funding requirements are specifically for people with type 1 diabetes, the committee thought that this criterion was also important for people with type 2 diabetes who have to monitor their blood glucose levels multiple times a day.

People who need help from a care worker or other healthcare professional to administer their insulin injections should also be offered isCGM, even if they only use once-daily insulin injections. isCGM will help care workers to record a person's blood glucose levels quickly. And for people who have multiple home care visits per day, blood glucose levels can be recorded at each visit. This will help them to adjust their insulin levels to reduce the risk of hypoglycaemic events between home visits. It may also reduce the number of hospital admissions for this group.

The committee discussed how short-term use of isCGM may still be useful for some people. It may help people to understand when they have hypoglycaemic episodes, which would help them to develop a more effective treatment plan.

There was no evidence that real-time CGM (rtCGM) was cost effective for people with type 2 diabetes, so the committee agreed it could not be recommended for all adults with type 2 diabetes (whether or not they used insulin). They noted, however, that prices of rtCGM have reduced over the past few years, and if this continues to happen there may come a time when it is no more expensive than isCGM. At this point, rtCGM would be an appropriate alternative for people who meet the criteria for isCGM.

The committee did not make a recommendation on using specific devices because CGM technologies are changing very quickly and this recommendation would soon be out of date. Local healthcare services are better placed to assess which devices are evidence-based and suitable for use at any given time.

The committee discussed how self-monitoring of blood glucose should still take place, albeit less frequently, even when a person is using CGM. The ability to self-monitor blood glucose levels allows people to ensure the accuracy of the CGM device. The committee also recommended keeping capillary blood glucose monitoring as a back-up for situations such as when the technology fails.

The committee decided to highlight that CGM should be provided by a team who have expertise in its use. To ensure that CGM is effective, healthcare professionals need to have the skills to interpret and communicate the data effectively. As well as healthcare professionals having a clear understanding of CGM, it is also crucial that people with type 2 diabetes who are using CGM have education about the technology. This will increase the likelihood that people will scan and report the results frequently, allowing people to understand and manage their diabetes effectively.

Although many people will choose CGM if offered, there are some people who either cannot be offered it or do not want to use it. Because it is still important for these people to monitor their blood glucose levels, the committee made a recommendation to reinforce the importance of offering capillary blood glucose monitoring instead.

The committee did not make a recommendation on how long CGM should be used because there was no evidence on this, and they did not want to stop people accessing CGM for short periods if they and their healthcare professional thought they could benefit from this. Using CGM for a short period of time may help some people to understand when they have hypoglycaemic episodes, thereby helping them to develop a more effective treatment plan.

Despite the positive recommendations on CGM, the committee were concerned that existing health inequalities may still lead to lower uptake of CGM in some groups of people. To address this, the committee made a recommendation outlining actions for commissioners, providers and healthcare professionals.

The committee highlighted the importance of routinely reviewing a person's use of CGM. This will establish whether it is providing clinical benefits and whether the monitor is being used correctly. Making people aware that their use of CGM will be continually reviewed is important so they know it is not a guaranteed long-term option.

The committee also made a recommendation for research on using routinely collected real-world data to assess the effectiveness and cost effectiveness of CGM. They agreed that this has the potential to show the direct effects of the technology used by people with type 2 diabetes instead of interpreting it through the results of clinical trials. Increased monitoring of routine healthcare data including registries and audits would ensure that findings from a broader population are captured.

How the recommendations might affect practice

The recommendations are likely to increase the number of adults with type 2 diabetes who are offered CGM, particularly those who have issues with hypoglycaemia. This will have associated cost implications:

Return to recommendations

Why the committee made the recommendations

How the recommendations might affect practice

The recommendations to offer SGLT2 inhibitors with metformin to adults with type 2 diabetes and chronic heart failure or established atherosclerotic cardiovascular disease at first-line treatment (or if they are already taking metformin monotherapy) are expected to lead to a change in practice and increase the number of people taking SGLT2 inhibitors at the beginning of their treatment. This is also expected to be the case for people with a high risk of developing cardiovascular disease, as this category is expected to cover a large proportion of adults with type 2 diabetes. In current practice, these people would not be offered combination therapy with an SGLT2 inhibitor until additional treatment is needed to control their HbA1c to below their individually agreed threshold for intervention, and then only if they met the criteria in the relevant NICE technology appraisals for being prescribed an SGLT2 inhibitor. Overall, this recommendation is expected to greatly increase the number of people taking SGLT2 inhibitors and is likely to have a substantial resource impact.

The number of adults with type 2 diabetes and chronic heart failure or established atherosclerotic cardiovascular disease or a high risk of developing cardiovascular disease who cannot tolerate metformin, or for whom metformin is contraindicated, are expected to be relatively low. The new recommendations are likely to see a change in practice as more people start taking an SGLT2 inhibitor, and this will likely be associated with a resource impact.

The recommendations about how to begin combination therapy, factors to check before a person starts on an SGLT2 inhibitor, and topics to cover in a conversation with the person, are not expected to significantly increase consultation time or be a change in practice because these should already form part of the prescribing process. Checking that the person is not at increased risk of DKA when they are prescribed an SGLT2 inhibitor should help reduce the number of people who experience DKA and thereby reduce unnecessary hospital admissions.

Return to recommendations

Why the committee made the recommendations

The committee agreed that when changes to treatment are being considered it is important to review existing treatment options first. Stopping medications that have not worked, for example, in controlling blood glucose or weight loss, and optimising current treatments may remove the need to prescribe additional drugs. However, some drugs, such as SGLT2 inhibitors, may be continued because they provide additional cardiovascular protective benefits. In particular, there might be reasons, such as problems with adherence or adverse effects, that might make existing treatments less effective or ineffective. Addressing these might mean that adding a new drug is unnecessary.

The list of factors to think about as part of optimisation is not exhaustive but includes those that the committee thought were particularly important. The committee agreed that it is important to revisit advice about diet and lifestyle because part of this discussion is to ensure the person is supported with both non-pharmacological and pharmacological interventions to improve their current health and prognosis.

Reviews should also take into account a person's current clinical circumstances (as detailed in recommendation 1.7.1 on choosing drug treatments). This will help ensure that appropriate treatment options are considered if the person's clinical situation has changed: for example, if it has improved because of weight loss or if they have developed chronic heart failure or atherosclerotic cardiovascular disease.

When people with an elevated lifetime risk of cardiovascular disease turn 40, their cardiovascular risk may appear to drop when it is assessed using QRISK2. However, this is due to switching from assessing lifetime risk to a 10-year risk calculation rather than an actual decrease in cardiovascular risk. SGLT2 inhibitor treatment should not be stopped for this reason alone.

Based on the evidence and the economic model, the benefits of SGLT2 inhibitors were not confined to first-line treatment for people with elevated cardiovascular risk or chronic heart failure or established atherosclerotic cardiovascular disease. To ensure that people who are already on drug therapy (including those people who have started first-line treatment, and those people who are further along the treatment pathway and are taking dual or triple therapy) for type 2 diabetes can have an SGLT2 inhibitor if their level of cardiovascular risk is sufficiently high or they have chronic heart failure or established atherosclerotic cardiovascular disease, the committee included a separate recommendation on SGLT2 inhibitors for these people. As explained in the rationale for recommendations on first-line treatment, the committee specified SGLT2 inhibitors with proven cardiovascular benefits.

This recommendation also takes into account that adults with type 2 diabetes may develop these conditions (or an increase in their risk) over time. If that happens, an SGLT2 inhibitor could then be of benefit to them. The committee agreed that it was very important to highlight that it may be more appropriate to replace an existing therapy with an SGLT2 inhibitor than to add to it, depending on the person's circumstances. This is because they were aware that treatment optimisation as detailed in recommendation 1.7.14 is not always carried out in practice.

How the recommendations might affect practice

The recommendation about reviewing drug treatment is not expected to be a change in practice or to need substantial additional resources because these conversations should already take place. However, the wider use of SGLT2 inhibitors in people who are already being treated for type 2 diabetes and who have or develop high cardiovascular risk or chronic heart failure or established atherosclerotic cardiovascular disease is expected to lead to an increase in resource use.

Return to recommendations

Why the committee did not make any new recommendations in 2022

The committee did not make any new recommendations on further treatment options. They agreed that for later stages of treatment, separate recommendations were not needed for people at high risk of developing cardiovascular disease or with chronic heart failure or established atherosclerotic cardiovascular disease. This was for several reasons.

Firstly, the evidence and the economic model continued to show that an SGLT2 inhibitor was likely to be the most cost-effective option for these people. Secondly, the recommendations they had made on first-line treatment using an SGLT2 inhibitor (either with metformin, or alone if metformin is contraindicated or not tolerated) and for switching or adding this drug at later stages meant that these people would be able to access an SGLT2 inhibitor without adding this consideration to the existing 2015 recommendations.

Finally, the alternative treatment options for people with and without increased cardiovascular risk remained the same for later treatment stages. Therefore, the committee agreed to retain the existing 2015 recommendations for treatment options if further interventions are needed, without making any changes based on cardiovascular risk.

To simplify treatment options, the committee merged recommendations for people in whom metformin is contraindicated or not tolerated into the existing 2015 recommendations where possible, and added the NICE technology appraisals as bullet points to the relevant existing recommendations.

The evidence reviewed in this update was limited to the cardiovascular benefits of GLP‑1 mimetics and the committee agreed that this was only generalisable to people with a high risk of developing cardiovascular disease or with chronic heart failure or established atherosclerotic cardiovascular disease. As for first-line treatment, GLP-1 mimetics as a class were not cost-effective options for later stages of treatment, and there was too much uncertainty in the clinical and cost effectiveness to support recommending injectable semaglutide (see the rationale and impact section on first-line drug treatment).

The committee did not look at clinical- and cost-effectiveness evidence for the use of GLP‑1 mimetics to control blood glucose levels. As a result, the committee were unable to update the 2015 GLP‑1 mimetic recommendations in this update. However, the committee were concerned that, as written, the 2015 recommendation on GLP1‑mimetics would mean that people taking newer drugs with proven cardiovascular benefit, such as SGLT2 inhibitors, would have to switch to a combination of metformin, a sulfonylurea and a GLP‑1 mimetic. They agreed that this might be clinically inappropriate and not in keeping with current clinical practice, so they amended recommendation 1.7.21 to remove the requirement for this specific combination of treatment options. The rest of the recommendation and the other recommendations for GLP‑1 mimetics were out of scope for this update, so the criteria for accessing a GLP‑1 mimetic remain unchanged. These recommendations set tight limits on who should be offered a GLP‑1 mimetic, based on the lack of cost effectiveness of this treatment for most people in the 2015 guideline.

How the recommendations might affect practice

Since no new drug options have been added to later stages of treatment, these recommendations are not expected to lead to an increase in resource impact over that detailed above for starting drug treatment with metformin and an SGLT2 inhibitor, or an SGLT2 inhibitor alone, or for people who are already on drug therapy when an SGLT2 inhibitor is or becomes appropriate based on their cardiovascular risk.

Removing the previous restriction limiting the use of GLP‑1 mimetics to combination therapy with metformin and a sulfonylurea may increase the use of GLP‑1 mimetics at later stages of the treatment pathway by making additional combinations of triple therapy that include GLP‑1 mimetics available to eligible people. However, these drugs are already widely used in some areas and this change may bring the guideline into line with current practice.

Return to recommendations

Why the committee made the recommendations

Biosimilars have the potential to offer the NHS considerable cost savings. To gain approval for use, biosimilar medicines have to be shown to be safe and as effective as the original reference medicine, and have the same quality. Based on this understanding, the committee noted it was appropriate when starting a new prescription of an insulin where a biosimilar is available, to use the one with the lowest cost.

Additionally, people may be using an insulin for which a lower cost biosimilar is available. In such cases, the committee recommended discussing with people the possibility of switching to the biosimilar. This could happen at the person's routine review. They also agreed that switching to the biosimilar should be carefully planned, taking into consideration the dose-switching protocols, monitoring and the person's concerns about switching from their existing regimen, and a shared decision reached. Healthcare professionals should also refer to the summary of product characteristics for further information when considering switching to biosimilars.

Return to recommendations

Why the committee made the recommendations

Strong evidence from well-conducted randomised controlled trials showed that SGLT2 inhibitors reduced the risk of chronic kidney disease (CKD) progression, mortality and cardiovascular events in adults with type 2 diabetes and CKD.

Economic modelling for people with an albumin-to-creatinine ratio (ACR) above 30 mg/mol at baseline showed that SGLT2 inhibitors were likely to be both more effective and cost saving in this group compared with standard treatment.

People with a baseline ACR of 3 mg/mmol to 30 mg/mmol will experience fewer cardiovascular events and events relating to CKD progression than people with a higher ACR. Because of this, SGLT2 inhibitors would prevent fewer events for this group in absolute terms, even if the relative effect was the same. Economic modelling showed that SGLT2 inhibitors were still likely to be both more effective and cost saving in people with a baseline ACR of between 3 mg/mol and 30 mg/mol compared with standard treatment. However, there was more uncertainty around the clinical and cost effectiveness in this group than in people with a baseline ACR over 30 mg/mmol. Because of this, SGLT2 inhibitors may not be suitable for everyone with a baseline ACR of between 3 mg/mmol and 30 mg/mmol, and the committee made a different recommendation for this group.

There was no evidence specifically looking at the effectiveness of SGLT2 inhibitors for people with a baseline ACR of less than 3 mg/mol, so the committee made a recommendation for research for this group.

The committee cautioned that SGLT2 inhibitors are not suitable for everyone and should only be used within their marketing authorisation.

Some ethnic groups have a higher risk of micro- and macrovascular complications and so may benefit more from SGLT2 inhibitors. However, no evidence was found that stratified data by ethnicity. To address this gap, the committee made a recommendation for research.

For an explanation of why the committee recommended angiotensin receptor blockers (ARBs) and angiotensin-converting enzyme (ACE) inhibitors, see the section on pharmacotherapy in NICE's guideline on chronic kidney disease.

How the recommendations might affect practice

The recommendations will lead to a significant change in practice, since SGLT2 inhibitors will be prescribed more widely. This will result in a substantial cost impact. The committee noted, however, that there was likely to be a long-term cost saving from reduced downstream treatment costs, as SGLT2 inhibitors slow CKD progression and reduce the number of cardiovascular and end-stage renal events.

Return to recommendations

Why the committee made the recommendations

The evidence showed that people with diabetes are at increased risk of periodontitis, and that non-surgical periodontal treatment can improve diabetes control. However, in the committee's experience, people with diabetes are often unaware of this and may not be having regular oral health reviews. To address this, the committee recommended routinely discussing the risk of periodontitis at annual reviews, alongside eye disease and foot problems.

The evidence also showed that periodontal treatment is cost effective for people with type 2 diabetes, assuming improvements in HbA1c are maintained. This was tested with health economic modelling in a range of different scenarios. There were some scenarios where periodontal treatment was not cost effective, but the committee did not think these scenarios reflected real-world practice.

How the recommendations might affect practice

For oral healthcare professionals, the long-term impact of the recommendations is uncertain. The recommendations specify that people should follow existing NICE guidelines on oral health. However, the recommendations may also increase awareness of periodontitis, leading to a possible short-term increase in the number of oral health reviews. Any increase in the number of oral health reviews will potentially impact on services, as NHS dental services already have capacity issues.

A short-term increase in the number of oral health reviews will also lead to a short-term increase in costs. However, there is likely to be a larger long-term reduction in costs from the improvement to oral health and diabetes control.

Oral healthcare and dental teams will need clear advice on what they need to do for people with diabetes. They will need clear care pathways to improve quality of care and service delivery, in line with the NHS England commissioning standard on dental care for people with diabetes.

Many people do not have regular oral health reviews, even if they are eligible for free NHS dental care. People are eligible for free dental care if they are:

The recommendations may encourage more people with diabetes to have regular oral health reviews. Combined with proactive engagement and enhanced support for people with diabetes, this may broaden access to dental and oral healthcare and help to reduce oral health inequalities.

Return to recommendations