HbA1c measurement and targets

Self-monitoring of capillary blood glucose

These recommendations relate to self-monitoring by capillary blood glucose monitoring.

1.6.12.

Take the Driver and Vehicle Licensing Agency (DVLA)’s Assessing fitness to drive: a guide for medical professionals into account when offering self-monitoring of capillary blood glucose levels for adults with type 2 diabetes. [2015, amended 2022]

1.6.13.

Do not routinely offer self-monitoring of capillary blood glucose levels for adults with type 2 diabetes unless:

• the person is on insulin or
• there is evidence of hypoglycaemic episodes or
• the person is on oral medication that may increase their risk of hypoglycaemia while driving or operating machinery or
• the person is pregnant or is planning to become pregnant (see the NICE guideline on diabetes in pregnancy). [2015, amended 2022]

1.6.14.

Consider short-term self-monitoring of capillary blood glucose levels in adults with type 2 diabetes, reviewing treatment as necessary:

• when starting treatment with oral or intravenous corticosteroids or
• to confirm suspected hypoglycaemia. [2015, amended 2022]

1.6.15.

Be aware that adults with type 2 diabetes who have acute intercurrent illness are at risk of worsening hyperglycaemia. Review treatment as necessary. [2015]

1.6.16.

If adults with type 2 diabetes are self-monitoring their capillary blood glucose levels, carry out a structured assessment at least annually. The assessment should include:

• the person’s self-monitoring skills
• the quality and frequency of testing
• checking that the person knows how to interpret the blood glucose results and what action to take
• the impact on the person’s quality of life
• the continued benefit to the person
• the equipment used. [2015, amended 2022]

Continuos glucose monitoring

1.6.17.

Offer intermittently scanned continuous glucose monitoring (isCGM, commonly referred to as ‘flash’) to adults with type 2 diabetes on multiple daily insulin injections if any of the following apply:

• they have recurrent hypoglycaemia or severe hypoglycaemia
• they have impaired hypoglycaemia awareness
• they have a condition or disability (including a learning disability or cognitive impairment) that means they cannot self-monitor their blood glucose by capillary blood glucose monitoring but could use an isCGM device (or have it scanned for them)
• they would otherwise be advised to self-measure at least 8 times a day.
  For guidance on continuous glucose monitoring (CGM) for pregnant women, see the NICE guideline on diabetes in pregnancy. [2022]

1.6.18.

Offer isCGM to adults with insulin-treated type 2 diabetes who would otherwise need help from a care worker or healthcare professional to monitor their blood glucose. [2022]

1.6.19.

Consider real-time continuous glucose monitoring (rtCGM) as an alternative to isCGM for adults with insulin-treated type 2 diabetes if it is available for the same or lower cost. [2022]

1.6.20.

CGM should be provided by a team with expertise in its use, as part of supporting people to self-manage their diabetes. [2022]

1.6.21.

Advise adults with type 2 diabetes who are using CGM that they will still need to take capillary blood glucose measurements (although they can do this less often). Explain that is because:

• they will need to use capillary blood glucose measurements to check the accuracy of their CGM device
• they will need capillary blood glucose monitoring as a back-up (for example when their blood glucose levels are changing quickly or if the device stops working).
  Provide them with enough test strips to take capillary blood glucose measurements as needed. [2022]

1.6.22.

If a person is offered rtCGM or isCGM but cannot or does not want to use any of these devices, offer capillary blood glucose monitoring. [2022]

1.6.23.

Ensure CGM is part of the education provided to adults with type 2 diabetes who are using it (see the section on education). [2022]

1.6.24.

Monitor and review the person’s use of CGM as part of reviewing their diabetes care plan (see the section on individualised care). [2022]

1.6.25.

If there are concerns about the way a person is using the CGM device:

• ask if they are having problems using their device
• look at ways to address any problems and concerns to improve their use of the device, including further education and emotional and psychological support. [2022]

1.6.26.

Commissioners, providers and healthcare professionals should address inequalities in CGM access and uptake by:

• monitoring who is using CGM
• identifying groups who are eligible but who have a lower uptake
• making plans to engage with these groups to encourage them to consider CGM. [2022]

Choosing drug treatments

We have produced a visual summary to provide an overview of the recommendations and additional information to support medicines choice.

1.7.1.

Discuss with adults with type 2 diabetes the benefits and risks of drug treatment and the options available. Base the choice of drug treatments on:

• the person’s individual clinical circumstances, for example comorbidities, contraindications, weight, and risks from polypharmacy
• the person’s individual preferences and needs
• the effectiveness of the drug treatments in terms of metabolic response and cardiovascular and renal protection
• safety and tolerability of the drug treatment
• monitoring requirements
• the licensed indications or combinations available
• cost (if 2 drugs in the same class are appropriate, choose the option with the lowest acquisition cost). [2015, amended 2022]
  See the NICE guideline on shared decision making and the section on safety of medicines for diabetes before and during pregnancy in the NICE guideline on diabetes in pregnancy.

Rescue therapy at any phase of treatment

1.7.2.

If an adult with type 2 diabetes is symptomatically hyperglycaemic, consider insulin (see the section on insulin-based treatments) or a sulfonylurea, and review treatment when blood glucose control has been achieved. [2015]

First-line drug treatment

Also see the visual summary on first-line drug treatment for an overview of the recommendations and additional information to support medicines choice.

For adults with type 2 diabetes and chronic kidney disease, follow recommendations on SGLT2 inhibitors in the section on chronic kidney disease in this guideline.

1.7.3.

Offer standard-release metformin as first-line drug treatment to adults with type 2 diabetes. [2015]

1.7.4.

Assess the person’s cardiovascular status and risk to determine whether they have chronic heart failure or established atherosclerotic cardiovascular disease or are at high risk of developing cardiovascular disease.

See the recommendations on using risk scores and QRISK2 to assess cardiovascular disease risk in adults with type 2 diabetes in NICE’s guideline on cardiovascular disease: risk assessment and reduction, including lipid modification. [2022]

1.7.5.

Based on the cardiovascular risk assessment for the person with type 2 diabetes:

• If they have chronic heart failure or established atherosclerotic cardiovascular disease, offer an SGLT2 inhibitor with proven cardiovascular benefit in addition to metformin.
• If they are at high risk of developing cardiovascular disease, consider an SGLT2 inhibitor with proven cardiovascular benefit in addition to metformin. [2022]

1.7.6.

When starting an adult with type 2 diabetes on dual therapy with metformin and an SGLT2 inhibitor as first-line therapy, introduce the drugs sequentially, starting with metformin and checking tolerability. Start the SGLT2 inhibitor as soon as metformin tolerability is confirmed. [2022]

1.7.7.

Gradually increase the dose of standard-release metformin over several weeks to minimise the risk of gastrointestinal side effects in adults with type 2 diabetes. [2015]

1.7.8.

If an adult with type 2 diabetes experiences gastrointestinal side effects with standard-release metformin, consider a trial of modified-release metformin. [2015]

1.7.9.

For first-line drug treatment in adults with type 2 diabetes, if metformin is contraindicated or not tolerated:

• If they have chronic heart failure or established atherosclerotic cardiovascular disease, offer an SGLT2 inhibitor with proven cardiovascular benefit.
• If they are at high risk of developing cardiovascular disease, consider an SGLT2 inhibitor with proven cardiovascular benefit. [2022]

1.7.10.

For first-line drug treatment in adults with type 2 diabetes, if metformin is contraindicated or not tolerated and if they are not in either of the groups in recommendation 1.7.9, consider:

• a DPP-4 inhibitor or
• pioglitazone or
• a sulfonylurea or
• an SGLT2 inhibitor for people who meet the criteria in NICE’s technology appraisal guidance on canagliflozin, dapagliflozin and empagliflozin as monotherapies or ertugliflozin as monotherapy or with metformin for treating type 2 diabetes. [2015, amended 2022]

1.7.11.

Before starting an SGLT2 inhibitor, check whether the person may be at increased risk of diabetic ketoacidosis (DKA), for example if:

• they have had a previous episode of DKA
• they are unwell with intercurrent illness
• they are following a very low carbohydrate or ketogenic diet. [2022]

1.7.12.

Address modifiable risks for DKA before starting an SGLT2 inhibitor. For example, for people who are following a very low carbohydrate or ketogenic diet, they may need to delay treatment until they have changed their diet. [2022]

1.7.13.

Advise adults with type 2 diabetes who are taking an SGLT2 inhibitor about the need to minimise their risk of DKA by not starting a very low carbohydrate or ketogenic diet without discussing it with their healthcare professional, because they may need to suspend SGLT2 inhibitor treatment. [2022]

Reviewing drug treatments

1.7.14.

When reviewing or considering changing treatments for adults with type 2 diabetes, think about and discuss the following with the person:

• how to optimise their current treatment regimen before thinking about changing treatments, taking into account factors such as:

  —

  adverse effects

  —

  adherence to existing medicines

  —

  the need to revisit advice about diet and lifestyle

  —

  prescribed doses and formulations

• stopping medicines that have had no impact on glycaemic control or weight, unless there is an additional clinical benefit, such as cardiovascular or renal protection, from continued treatment (see the note below on off-label use)
• whether switching rather than adding drugs could be effective
• the considerations about treatment choice in recommendation 1.7.1. [2022]
  In February 2022, using ertugliflozin to reduce cardiovascular risk when blood glucose is well controlled was off-label. See NICE’s information on prescribing medicines.
  Also see the recommendations on medication review in the NICE guideline on medicines optimisation and on reviewing medicines and supporting adherence in the NICE guideline on medicines adherence.

1.7.15.

For adults with type 2 diabetes who start taking an SGLT2 inhibitor before they are 40 because they have an elevated lifetime risk of cardiovascular disease, do not stop the SGLT2 inhibitor when they turn 40 even if their QRISK2 score is below 10%. Only stop the SGLT2 inhibitor if the person’s circumstances have changed and the SGLT2 inhibitor is no longer appropriate. [2022]

Adding an SGLT2 inhibitor at any stage after first-line treatment has been started

1.7.16.

For adults with type 2 diabetes at any stage after they have started first-line treatment:

• If they have or develop chronic heart failure or established atherosclerotic cardiovascular disease, offer an SGLT2 inhibitor with proven cardiovascular benefit in addition to current treatment or replace an existing drug with the SGLT2 inhibitor.
• If they are or become at high risk of developing cardiovascular disease, consider adding an SGLT2 inhibitor with proven cardiovascular benefit to current treatment or replacing an existing drug with the SGLT2 inhibitor.
  Take into account the person’s current treatment regimen and preferences and make a shared decision about switching treatments or adding an SGLT2 inhibitor, as appropriate (also see recommendations 1.7.12 and 1.7.13 on starting an SGLT2 inhibitor). [2022]
  In February 2022, using ertugliflozin to reduce cardiovascular risk when blood glucose is well controlled was off-label. See NICE’s information on prescribing medicines.

Treatment options if further interventions are needed

Also see our visual summary on treatment options if further interventions are needed for an overview of the recommendations and additional information to support medicines choice.

1.7.17.

Introduce drugs used in combination therapy in a stepwise manner, checking for tolerability and effectiveness of each drug. [2015]

1.7.18.

For adults with type 2 diabetes, if monotherapy has not continued to control HbA1c to below the person’s individually agreed threshold for further intervention, consider adding:

• a DPP-4 inhibitor or
• pioglitazone or
• a sulfonylurea or
• an SGLT2 inhibitor for people who meet the criteria in NICE’s technology appraisal guidance on canagliflozin in combination therapy, ertugliflozin as monotherapy or with metformin, or dapagliflozin or empagliflozin in combination therapy. [2015, amended 2022]

1.7.19.

For adults with type 2 diabetes, if dual therapy with metformin and another oral drug has not continued to control HbA1c to below the person’s individually agreed threshold for further intervention consider either:

• triple therapy by adding a DPP-4 inhibitor, pioglitazone or a sulfonylurea or an SGLT2 inhibitor for people who meet the criteria in NICE’s technology appraisal guidance on canagliflozin in combination therapy, dapagliflozin in triple therapy, empagliflozin in combination therapy, or ertugliflozin with metformin and a dipeptidyl peptidase-4 inhibitor or
• starting insulin-based treatment (see the section on insulin-based treatments). [2015, amended 2022]

1.7.20.

In adults with type 2 diabetes, if metformin is contraindicated or not tolerated and dual therapy with 2 oral drugs has not continued to control HbA1c to below the person’s individually agreed threshold for intervention, consider insulin-based treatment (see the section on insulin-based treatments). [2015, amended 2022]

1.7.21.

If triple therapy with metformin and 2 other oral drugs is not effective, not tolerated or contraindicated, consider triple therapy by switching one drug for a GLP-1 mimetic for adults with type 2 diabetes who:

• have a body mass index (BMI) of 35 kg/m² or higher (adjust accordingly for people from Black, Asian and other minority ethnic groups) and specific psychological or other medical problems associated with obesity or
• have a BMI lower than 35 kg/m² and:

  —

  for whom insulin therapy would have significant occupational implications or

  —

  weight loss would benefit other significant obesity-related comorbidities. [2015, amended 2022]

1.7.22.

Only continue GLP-1 mimetic therapy if the adult with type 2 diabetes has had a beneficial metabolic response (a reduction of at least 11 mmol/mol [1.0%] in HbA1c and weight loss of at least 3% of initial body weight in 6 months). [2015]

1.7.23.

For adults with type 2 diabetes, only offer combination therapy with a GLP-1 mimetic and insulin along with specialist care advice and ongoing support from a consultant-led multidisciplinary team. [2015]

Insulin-based treatments

1.7.24.

For adults with type 2 diabetes starting insulin therapy, provide a structured programme using active insulin dose titration that encompasses:

• injection technique, including rotating injection sites and avoiding repeated injections at the same point within sites
• continuing telephone support
• self-monitoring
• dose titration to target levels
• dietary advice
• the DVLA’s Assessing fitness to drive: a guide for medical professionals
• managing hypoglycaemia
• managing acute changes in plasma glucose control
• support from an appropriately trained and experienced healthcare professional. [2015]

1.7.25.

For adults with type 2 diabetes starting insulin therapy, continue to offer metformin for people without contraindications or intolerance. Review the continued need for other blood glucose lowering therapies. [2015]

1.7.26.

Start insulin therapy for adults with type 2 diabetes from a choice of the following insulin types and regimens:

• Offer neutral protamine Hagedorn (NPH) insulin injected once or twice daily according to need.
• Consider starting both NPH and short-acting insulin (particularly if the person’s HbA1c is 75 mmol/mol [9.0%] or higher), administered either:

  —

  separately or

  —

  as a pre-mixed (biphasic) human insulin preparation.

• Consider, as an alternative to NPH insulin, using insulin detemir or insulin glargine if:

  —

  the person needs help from a carer or healthcare professional to inject insulin, and use of insulin detemir or insulin glargine would reduce the frequency of injections from twice to once daily or

  —

  the person’s lifestyle is restricted by recurrent symptomatic hypoglycaemic episodes or

  —

  the person would otherwise need twice-daily NPH insulin injections in combination with oral glucose-lowering drugs.

• Consider pre-mixed (biphasic) preparations that include short-acting insulin analogues, rather than pre-mixed (biphasic) preparations that include short-acting human insulin preparations, if:

  —

  the person prefers injecting insulin immediately before a meal or

  —

  hypoglycaemia is a problem or

  —

  blood glucose levels rise markedly after meals. [2015]

1.7.27.

Consider switching to insulin detemir or insulin glargine from NPH insulin in adults with type 2 diabetes:

• who do not reach their target HbA1c because of significant hypoglycaemia or
• who experience significant hypoglycaemia on NPH insulin irrespective of the level of HbA1c reached or
• who cannot use the device needed to inject NPH insulin but could administer their own insulin safely and accurately if a switch to one of the long-acting insulin analogues was made or
• who need help from a carer or healthcare professional to administer insulin injections and for whom switching to one of the long-acting insulin analogues would reduce the number of daily injections. [2015]

1.7.28.

Monitor adults with type 2 diabetes who are on a basal insulin regimen (NPH insulin, insulin detemir or insulin glargine) for the need for short-acting insulin before meals (or a pre-mixed [biphasic] insulin preparation). [2015]

1.7.29.

Monitor adults with type 2 diabetes who are on pre-mixed (biphasic) insulin for the need for a further injection of short-acting insulin before meals or for a change to a basal-bolus regimen with NPH insulin or insulin detemir or insulin glargine, if blood glucose control remains inadequate. [2015]

1.7.30.

When starting an insulin for which a biosimilar is available, use the product with the lowest acquisition cost. [2021]

1.7.31.

Ensure the risk of medication errors with insulins is minimised by following the Medicines and Healthcare products Regulatory Agency (MHRA) guidance on minimising the risk of medication error with high strength, fixed combination and biosimilar insulin products, which includes advice for healthcare professionals when starting treatment with a biosimilar. [2021]

1.7.32.

When people are already using an insulin for which a lower cost biosimilar is available, discuss the possibility of switching to the biosimilar. Make a shared decision with the person after discussing their preferences. [2021]

For guidance on using insulin in combination with SGLT2 inhibitors, see:

• the section on drug treatment
• NICE’s technology appraisal guidance on canagliflozin, dapagliflozin, and empagliflozin in combination therapy.

Insulin delivery

1.7.33.

For guidance on insulin delivery for adults with type 2 diabetes, see the section on insulin delivery in the NICE guideline on type 1 diabetes. [2015]

Periodontitis

1.8.1.

Advise adults with type 2 diabetes at their annual review that:

• they are at higher risk of periodontitis
• if they get periodontitis, managing it can improve their blood glucose control and can reduce their risk of hyperglycaemia. [2022]

1.8.2.

Advise adults with type 2 diabetes to have regular oral health reviews (their oral healthcare or dental team will tell them how often, in line with the NICE guideline on dental checks: intervals between oral health reviews). [2022]

1.8.3.

For guidance for oral healthcare and dental teams on how to provide oral health advice, see the NICE guideline on oral health promotion. [2022]

1.8.4.

For adults with type 2 diabetes who have been diagnosed with periodontitis by an oral healthcare or dental team, offer dental appointments to manage and treat their periodontitis (at a frequency based on their oral health needs). [2022]

Gastroparesis

1.8.5.

Think about a diagnosis of gastroparesis in adults with type 2 diabetes who have erratic blood glucose control or unexplained gastric bloating or vomiting, taking into account possible alternative diagnoses. [2009, amended 2015]

1.8.6.

For adults with type 2 diabetes who have vomiting caused by gastroparesis, explain that:

• there is no strong evidence that any available antiemetic therapy is effective
• some people have had benefit with domperidone, erythromycin or metoclopramide
• the strongest evidence for effectiveness is for domperidone, but prescribers must take into account its safety profile, in particular its cardiac risk and potential interactions with other medicines. [2015]
  In December 2015, the use of erythromycin was off-label. See NICE’s information on prescribing medicines.

1.8.7.

To treat vomiting caused by gastroparesis in adults with type 2 diabetes:

• consider alternating the use of erythromycin and metoclopramide
• consider domperidone only in exceptional circumstances (if domperidone is the only effective treatment) and in accordance with MHRA guidance on domperidone. [2015]
  In December 2015, the use of erythromycin was off-label. See NICE’s information on prescribing medicines.

1.8.8.

If gastroparesis is suspected, consider referring adults with type 2 diabetes to specialist services if:

• the differential diagnosis is in doubt or
• the person has persistent or severe vomiting. [2009]

Painful diabetic neuropathy

1.8.9.

For guidance on managing painful diabetic peripheral neuropathy in adults with type 2 diabetes, see the NICE guideline on neuropathic pain in adults. [2015]

Autonomic neuropathy

1.8.10.

Think about the possibility of contributory sympathetic nervous system damage in adults with type 2 diabetes who lose the warning signs of hypoglycaemia. [2009, amended 2015]

1.8.11.

Think about the possibility of autonomic neuropathy affecting the gut in adults with type 2 diabetes who have unexplained diarrhoea that happens particularly at night. [2009, amended 2015]

1.8.12.

For adults with type 2 diabetes and autonomic neuropathy who are taking tricyclic drugs and antihypertensive drug treatments, be aware of the increased likelihood of side effects such as orthostatic hypotension. For guidance on safe prescribing of antidepressants (such as tricyclic drugs) and managing withdrawal, see NICE’s guideline on medicines associated with dependence or withdrawal symptoms. [2009]

1.8.13.

For adults with type 2 diabetes who have unexplained bladder-emptying problems, investigate the possibility of autonomic neuropathy affecting the bladder. [2009]

1.8.14.

In managing autonomic neuropathy symptoms, include specific interventions indicated by the manifestations (for example, for abnormal sweating or nocturnal diarrhoea). [2009]

Diabetic foot problems

1.8.15.

For guidance on preventing and managing foot problems in adults with type 2 diabetes, see the NICE guideline on diabetic foot problems. [2015]

Chronic kidney disease

1.8.16.

For adults with chronic kidney disease (CKD) and type 2 diabetes, offer an angiotensin receptor blocker (ARB) or an angiotensin-converting enzyme (ACE) inhibitor (titrated to the highest licensed dose that the person can tolerate) if albumin-to-creatinine ratio (ACR) is 3 mg/mmol or more, as recommended in the section on pharmacotherapy for CKD in adults, children, and young people with related persistent proteinuria in the NICE guideline on chronic kidney disease. [2021]

1.8.17.

For adults with type 2 diabetes and CKD who are taking an ARB or an ACE inhibitor (titrated to the highest licensed dose that they can tolerate), offer an SGLT2 inhibitor (in addition to the ARB or ACE inhibitor) if:

• ACR is over 30 mg/mmol and
• they meet the criteria in the marketing authorisation (including relevant estimated glomerular filtration rate [eGFR] thresholds).
  In November 2021, not all SGLT2 inhibitors were licensed for this indication. See NICE’s information on prescribing medicines. [2021]

1.8.18.

For adults with type 2 diabetes and CKD who are taking an ARB or an ACE inhibitor (titrated to the highest licensed dose that they can tolerate), consider an SGLT2 inhibitor (in addition to the ARB or ACE inhibitor) if:

• ACR is between 3 and 30 mg/mmol and
• they meet the criteria in the marketing authorisation (including relevant eGFR thresholds).
  In November 2021, not all SGLT2 inhibitors were licensed for this indication. See NICE’s information on prescribing medicines. [2021]

1.8.19.

For guidance on dapagliflozin for adults with CKD, see NICE’s technology appraisal guidance on dapagliflozin for treating chronic kidney disease. [2022]

1.8.20.

For further guidance on managing kidney disease in adults with type 2 diabetes, see the NICE guideline on chronic kidney disease. [2015]

Erectile dysfunction

1.8.21.

Offer men with type 2 diabetes the opportunity to discuss erectile dysfunction as part of their annual review. [2015]

1.8.22.

Assess, educate and support men with type 2 diabetes who have problematic erectile dysfunction, addressing contributory factors such as cardiovascular disease as well as possible treatment options. [2015]

1.8.23.

Consider a phosphodiesterase-5 inhibitor to treat problematic erectile dysfunction in men with type 2 diabetes. Initially choose the drug with the lowest acquisition cost and take into account any contraindications. [2015]

1.8.24.

After discussion, refer men with type 2 diabetes to a service offering other medical, surgical or psychological management of erectile dysfunction if treatment (including a phosphodiesterase-5 inhibitor, as appropriate) has been unsuccessful. [2015]

Eye disease

1.8.25.

When adults are diagnosed with type 2 diabetes, refer them immediately to the local eye screening service. [2009, amended 2020]

1.8.26.

Encourage adults to attend eye screening, and explain that it will help them to keep their eyes healthy and help to prevent problems with their vision. Explain that the screening service is effective at identifying problems so that they can be treated early. [2009]

1.8.27.

Arrange emergency review by an ophthalmologist for:

• sudden loss of vision
• rubeosis iridis
• pre-retinal or vitreous haemorrhage
• retinal detachment. [2009]

1.8.28.

Refer to an ophthalmologist in accordance with the UK National Screening Committee criteria and timelines for any large sudden unexplained drop in visual acuity. [2009, amended 2020]

1. The effects of stopping or switching drug treatments to control blood glucose levels

In adults with type 2 diabetes, what are the effects of stopping and/or switching drug treatments to control blood glucose levels, and what criteria should inform the decision? [2015]

2. Non-metformin-based drug treatment combinations to control blood glucose levels

In adults with type 2 diabetes, what treatment combinations (for example, glucagon-like peptide-1 [GLP-1] mimetics and insulin combination therapy with meglitinides) are most effective when initial drug treatment with non-metformin monotherapy fails to adequately control blood glucose levels? [2015]

3. Drug treatment for when blood glucose levels are inadequately controlled by 3 oral antidiabetic drugs or insulin combinations

When blood glucose levels are inadequately controlled by 3 oral antidiabetic drugs and/or insulin combinations, which blood glucose lowering therapies should be used to control blood glucose levels? [2015, amended 2021]

4. Self-monitoring of blood glucose levels

What is the optimal frequency for self-monitoring of blood glucose in adults with type 2 diabetes? [2015]

1. Effectiveness of SGLT2 inhibitors for different ethnic groups

What is the clinical and cost effectiveness of SGLT2 inhibitors in adults with type 2 diabetes and chronic kidney disease, stratified across different ethnic groups? [2021]

2. Effectiveness of SGLT2 inhibitors for adults with a urine albumin-to-creatinine ratio (ACR) below 3 mg/mmol

What is the clinical and cost effectiveness of SGLT2 inhibitors in adults with type 2 diabetes, chronic kidney disease and a urine ACR of less than 3 mg/mmol? [2021]

3. Long-term outcomes associated with blood glucose lowering agents

In adults with type 2 diabetes, what are the long-term effects of blood glucose lowering therapies such as dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium–glucose cotransporter-2 (SGLT2) inhibitors and meglitinides? [2015]

4. Using routinely collected real-world data to assess the effectiveness of continuous glucose monitoring

Based on routinely collected real-world data, what is the effectiveness and cost effectiveness of CGM devices to improve glycaemic control in adults with type 2 diabetes? [2022]

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:

• It may save the NHS time, because healthcare professionals do not have to meet people who are using CGM as often as people who use capillary blood glucose monitoring.
• There should be fewer hypoglycaemic events to manage.
  The committee did not expect a significant resource impact related to education and monitoring for the CGM devices.

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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.

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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.

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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.

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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.

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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.

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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:

• pregnant
• mothers with babies under 1 year old
• on low income benefits, or under 20 and dependent on someone who is receiving low income benefits
• having treatment in an NHS hospital by the hospital dentist.

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.

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