Dr David Edwards explores recent NICE guidance on type 2 diabetes in adults and changes in approach to managing the condition and its complications
Read this article to learn more about:
- updates to NICE guidance on the management of type 2 diabetes in adults
- the importance of continuing education, advice, and patient-centred care
- stepwise drug treatment and managing complications.
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D iabetes has huge financial, health, and wellbeing considerations for the NHS, as well as for society and the individual. Around 3.5 million people in the UK have been diagnosed with diabetes, and it has been estimated that around 90% of people who are currently diagnosed with diabetes have type 2 diabetes (T2D).1,2
Type 2 diabetes is more common in people of African, African Caribbean, and South Asian origin; it is also being more frequently diagnosed in children, but it can affect people of all ages.1
Updated NICE guideline on type 2 diabetes in adults
The updated NICE guideline on Type 2 diabetes in adults: management (NICE Guideline [NG] 28)1 was published in December 2015; see Boxes 1 and 2, below. It can be read in conjunction with (but should not be confused with) NICE NG18 on type 1 and type 2 diabetes in children and young people.3 NICE NG28 updates and replaces NICE Clinical Guideline (CG) 87.4 Although the full version of NG28 extends to nearly 350 pages,5 the NICE guideline contains an overview and can be easily searched and digested in bitesized pieces. There is also a version of the guideline written for the public.
This article aims to summarise the main changes made in NG281 to the updated and replaced 2009 guideline.4
The need for an update
An update to the 2009 guideline4 was prompted in part by new pharmacological developments including safety concerns, new research evidence, new indications, the use of licensed combination therapy, and the potential impact of drugs coming off patent.
Scope and remit
NICE Guideline 28 is intended for use by healthcare professionals (HCPs) dealing with adults with T2D, commissioners and providers of diabetic services, and finally (but importantly) adults with T2D, together with their families and carers.1
This guideline covers the care and management of type 2 diabetes in adults (aged 18 years and over). It focuses on patient education, dietary advice, tackling cardiovascular risk, managing blood glucose levels, and identifying and managing long-term complications. A list of the main areas with new or updated recommendations is shown in Box 3, below.
Box 3: Summary of areas with new or updated guidance in NICE Guideline 281
The updated guideline NG28 includes new recommendations on:
- individualised care
- managing blood glucose levels:
- HbA1c measurement and targets
- bbself-monitoring of blood glucose
- drug treatment
- blood pressure management
- antiplatelet therapy
- managing complications.
NICE. Type 2 diabetes in adults: management. NICE Guideline 28. NICE, 2015.
Reproduced with permission
Priorities for implementation
NICE has identified the following priority areas for implementation:
- patient education
- dietary advice
- blood pressure management
- blood glucose management
- drug treatment.
The text below covers updates to these priority aspects and other key aspects included in the guideline recommendations.
Particular consideration should be given to the broader social and healthcare needs of older patients with T2D. This demographic is likely to have complex comorbidities and drug treatments. It is essential that individual needs and preferences are considered so that people can make informed decisions about their holistic management.
The HCP needs to assess the patient’s risks from polypharmacy, and their ability to benefit from long-term interventions if their life expectancy is reduced; this is especially important where there is multimorbidity.
At review, it is necessary to reassess the person’s needs and circumstances and consider whether to stop any ineffective medicines.1
Patients, carers, and family members should be offered structured education at and around the time of diagnosis, together with annual reviews explaining that continuing education is an integral part of T2D care. This education needs to be evidence-based, enrich knowledge and skills in self-management, and be targeted to the individual. The material needs to be written down, delivered by trained, competent educators appropriate to the patient’s age and needs, independently assessed, and regularly audited.1
The personalised diabetes management plan should include a combination of dietary, physical activity, weight, and lifestyle advice.1
Blood pressure management
If lifestyle advice does not reduce blood pressure (BP) to below 140/80 mmHg (130/80 mmHg if eye, kidney, or cerebrovascular damage is present) then medication should be added, BP monitored every 1–2 months, and therapy intensified as necessary. New advice in NICE NG28 includes:1
- do not combine an ACE inhibitor with an angiotensin II-receptor antagonist to treat hypertension.
- if the person’s blood pressure is not reduced to the individually agreed target with first-line therapy, add a calcium-channel blocker or a diuretic (usually a thiazide or thiazide-related diuretic). Add the other drug (that is, the calcium-channel blocker or diuretic) if the target is not reached with dual therapy.
NICE has now added this advice:1
- do not offer antiplatelet therapy (aspirin or clopidogrel) for adults with type 2 diabetes without cardiovascular disease
- for guidance on the primary and secondary prevention of cardiovascular disease in adults with type 2 diabetes, see the NICE guidelines on cardiovascular disease6 and myocardial infarction7.
Blood glucose management
Blood glucose management involves measurement, targets, self-monitoring of blood glucose, and drug treatment.
Regular measurement of HbA1c is necessary to assess the effectiveness of the chosen treatment. NICE NG28 recommends that adults with T2D should have their HbA1c levels measured at:1
- 3–6-monthly intervals (tailored to individual needs), until the HbA1c is stable on unchanging therapy
- 6-monthly intervals once the HbA1c level and blood glucose lowering therapy are stable
NICE NG28 places emphasis on involving the patient with decisions about their individual HbA1c target. Lifestyle advice and drug treatment should be offered to adults with T2D to support them in achieving and maintaining their HbA1c target.
NICE NG28 recommends that adults whose diabetes is managed by lifestyle and diet, or by lifestyle and diet combined with a single drug not associated with hypoglycaemia should be supported to aim for an HbA1c level of 48 mmol/mol (6.5%). Adults on a drug that is associated with hypoglycaemia should be supported to aim for an HbA1c level of 53 mmol/mol (7.0%).
If HbA1c levels are not adequately controlled by a single drug and rise to 58 mmol/mol (7.5%) or higher:1
- advice about diet, lifestyle, and treatment adherence should be reinforced, and
- the person should be supported to aim for an HbA1c level of 53 mmol/mol (7.0%), and
- drug treatment should be intensified.
Practitioners should consider relaxing the target HbA1c level on an individual basis, particularly for people who are older or frail, or for whom intensive management would not be safe or appropriate.1
Self-monitoring of blood glucose
NICE NG28 recommends that self-monitoring of blood glucose should only be offered to adults with T2D if:1
- the person is on insulinor
- there is evidence of hypoglycaemic episodesor
- the person is on oral medication that may increase their risk of hypoglycaemia while driving or operating machineryor
- the person is pregnant, or is planning to become pregnant. For more information, see the NICE guideline on diabetes in pregnancy.8
There have been several changes to the older guideline4 that have now been included in NG28.1 These enable HCPs to decide how to use medications in a stepwise fashion known as ‘intensification’. Intensification allows for a structured approach in utilising oral and injectable medications. Practitioners should bear in mind the individual needs, preferences, and circumstances of the patient, and targets and treatment should be adjusted accordingly.
Standard-release metformin should be offered as initial treatment. If standard-release metformin is not tolerated then modified-release metformin can be tried.1
If metformin in any form is not tolerated or is contraindicated then a dipeptidyl peptidase-4 (DPP-4) inhibitor (DPP-4i), pioglitazone, or a sulfonylurea (SU) can be used first line. Pioglitazone is associated with an increased risk of heart failure, bladder cancer, and bone fracture. Known risk factors for these conditions, including increased age, should be carefully evaluated before treatment; safety and efficacy should be reviewed after 3–6 months.1
If the HbA1c rises to 58 mmol/mol (7.5%), then first intensification (dual therapy) can commence. The patient should be supported to aim for an HbA1c of 53 mmol/mol (7.0%).1
In adults who can take metformin, dual therapy should consist of metformin with:1
- a DPP-4i or
- an SU or
- pioglitazone or
- a sodium glucose co-transporter 2 inhibitor (SGLT-2i).
When metformin is contraindicated or not tolerated dual therapy should consist of:1
- a DPP-4i and pioglitazone or
- a DPP-4i and an SU or
- pioglitazone and an SU.
With second intensification the choice of agents is similar but the HCP needs to check the licences for their use in combination. Similarly, patients should be supported to aim for an HbA1c level of 53 mmol/mol (7.0%).1
For patients who can take metformin, consider:1
- triple therapy with:
- metformin, a DPP-4i, and an SU or
- metformin, pioglitazone, and an SU or
- metformin, canagliflozin, empagliflozin, and either pioglitazone or an SU or
- insulin-based treatment.
For adults with T2D in whom metformin is contraindicated or not tolerated, insulin-based treatment should be considered at second intensification (see section below on Insulin-based treatments).1
A glucagon-like peptide-1 (GLP-1) receptor antagonist can be used as triple therapy with metformin and an SU in patients who:1
- have a BMI of 35 kg/m2 or higher (culturally adjusted where necessary) and where psychological and medical problems are associated with obesity
- have a BMI lower than 35 kg/m2 where weight loss would benefit other significant co-morbidities associated with obesity or where insulin therapy may have significant occupational implications.
NICE NG28 recommends continuing GLP-1 receptor antagonist only if the person with T2D has had a beneficial metabolic response (HbA1c reduction of 11 mmol/mol [1%] and a weight loss of 3% or more of initial body weight in 6 months).1
Insulin-based treatment can be considered at second intensification. NICE NG28 includes new and updated recommendations on:1
- using a structured programme when starting insulin therapy
- continuing to offer metformin to people without contraindications or intolerance
- starting insulin therapy from a choice of insulin types and regimens:
- neutral protamine hagedorn [NPH] insulin once or twice daily
- in some circumstances, consider:
- starting both NPH insulin and short-acting insulin
- using insulin detemir or insulin glargine as an alternative to NPH insulin
- pre-mixed [biphasic] preparations that include short-acting insulin analogues
- when to consider switching from NPH insulin to insulin detemir or insulin glargine
- monitoring adults with T2D on the different insulin types and regimens.
NICE technology appraisals
Helpfully, NICE has produced technology appraisals (TAs) for the following agents:
- SGLT-2 inhibitors, canagliflozin (TA3159), dapagliflozin (TA28810), and empagliflozin (TA33611)
- NICE Guideline 28 incorporates recommendations about the GLP-1 agonists, exenatide and liraglutide.1
These can be accessed using the URL www.nice.org.uk/ followed by the TA code (e.g. TA28810). This enables the HCP and patient to make holistic prescribing choices.
NICE has published separate recent guidelines for each of the following complications:
NICE NG28 makes changes to the 2009 guideline4 regarding other complications, as detailed below.
NICE implementation tools1
NICE has developed the following tools to support the implementation of NICE Guideline 28 on Type 2 diabetes in adults—management:
- Educational resource
- algorithm for blood glucose lowering therapy in adults with type 2 diabetes
- Tailored education support
- patient decision aid and user guide
- Baseline assessment
- baseline assessment tool
- Costing report
- resource impact report
- Research recommendations
- research recommendations information
- ‘Do not do’ recommendations.
Tools to help professionals with implementation and audit are available in the NG28 resources section
Use of domperidone should be exercised with caution due to concerns about its safety profile, cardiac risks, and drug interactions. It should be explained to adults with T2D who have vomiting caused by gastroparesis that there is not strong evidence that any antiemetic therapy is effective; the strongest evidence is for domperidone, but the guideline recommends using it only in ‘exceptional circumstances’.1
This problem is common in men with diabetes. The wording of several recommendations in NICE NG28 has been revised as follows:1
- offer men with type 2 diabetes the opportunity to discuss erectile dysfunction as part of their annual review
- 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
- consider a phosphodiesterase-5 inhibitor to treat problematic erectile dysfunction in men with type 2 diabetes, initially choosing the drug with the lowest acquisition cost and taking into account any contraindications
- following 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.
These revisions to the recommendations promote holistic care of the man and encouraging the patient, his partner, and HCP to fine-tune lifestyle and comorbidity management.
A couple of amendments to the phrasing have also been made to the sections on autonomic neuropathy, as follows:1
- think about the possibility of contributory sympathetic nervous system damage for adults with type 2 diabetes who lose the warning signs of hypoglycaemia
- 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.
Diabetic eye disease
The guideline remains mainly unchanged from 2009 apart from the need to refer to an ophthalmologist a patient with diabetes who has ‘any large, sudden, unexplained drop in visual acuity’.1 Inclusion of the modifiers ‘large’ and ‘sudden’ ensure that significant ophthalmic disorders are diagnosed.
NICE NG28 covers the care and management of type 2 diabetes in adults (aged 18 and over). It focuses on patient education, dietary advice, managing cardiovascular risk and blood glucose levels, and identifying and managing long-term complications. By encouraging patients (and their partners) to become involved with their condition, it will hopefully enable patients to have better diabetic control and reduce or delay the onset of long-term complications, which is the expensive aspect of diabetes management.
- NICE NG28 on T2D in adults (Dec 2015) updates and replaces the previous NICE guideline (CG87, 2009)
- There is a separate NICE Guideline for children and young adults with type 1 and 2 diabetes (NG18)
- NICE NG28:
- is intended for use by HCPs; commissioning organisations, patients, their carers and families
- covers the care and management of T2D in adults (aged 18 and over)
- focuses on patient education, dietary advice, tackling cardiovascular risk, managing blood glucose levels, and identifying and managing long-term complications
- Increased emphasis is placed upon individualised care and patient education
- Encouragement is given to empower the patient, family, and carers into self-help management, particularly where lifestyle issues are concerned
- Many of the recommendations in the new guideline involve managing blood glucose levels by intensification of drug treatments in a stepwise fashion
- Some of the medical complications now have their own NICE guideline
- painful diabetic neuropathy
- diabetic foot problems
- diabetic kidney disease
- NICE has published TAs for the following medications: canagliflozin,9 dapagliflozin,10 empagliflozin11 (NG28 includes recommendations on exenatide and liraglutide)
- There have been changes to the wording of recommendations about other medical complications (i.e. gastroparesis, erectile dysfunction, autonomic neuropathy, and diabetic eye disease).
NG=NICE Guideline; T2D=type 2 diabetes; HCPs=healthcare professionals; TAs=technology appraisals
GP commissioning messages
written by Dr David Jenner, GP, Cullompton, Devon
- NICE NG28 provides updated recommendations on the management of T2D in adults, and includes multiple new recommendations about pharmacotherapies:
- many of the new anti-diabetic agents (e.g. DPP-4 and SGLT-2 inhibitors) are recommended at an earlier stage of treatment
- CCGs should:
- adapt their formularies to reflect the new recommendations from NG28
- be aware that the new anti-diabetic agents (e.g. DPP-4 and SGLT-2 inhibitors) are of relatively high acquisition cost compared with older therapies (e.g. metformin, sulfonylureas). Formularies should also show the rapidly changing prices of these anti-diabetic drugs
- consider contracting GP practices to initiate insulin therapy as a local enhanced service, to enable greater convenience for patients and reduce expensive tariff costs at hospitals
- Structured education remains advisory in this guidance; however, it no longer has the status of ‘Technology Appraisal Guidance’, which made it compulsory for CCGs to commission. It remains an element in QOF indicator DM014
- PbR tariff costs for a diabetic medicine outpatient: first attendance, £203; follow-up attendance, £95.a
T2D=type 2 diabetes; DPP-4=dipeptidyl peptidase-4; SGLT-2=sodium glucose co-transporter 2; QOF=quality and outcomes framework; PbR=payment by results
Read the Guidelines summary of NG28 on Type 2 diabetes in adults: management for more recommendations on managing type 2 diabetes in patients over 18 years
- NICE. Type 2 diabetes in adults: management. NICE Guideline 28. NICE, 2015. Available at:www.nice.org.uk/ng28
- Diabetes UK. Diabetes prevalence 2015 (November 2015). Available at: www.diabetes.org.uk/About_us/What-we-say/Statistics/Diabetes-prevalence-2013/ (accessed 6 April 2016).
- NICE. Diabetes (type 1 and type 2) in children and young people: diagnosis and management. NICE Guideline 18. NICE, 2015. Available at: www.nice.org.uk/ng18
- NICE. Type 2 diabetes: the management of type 2 diabetes. NICE Clinical Guideline 87. NICE, 2009. Available at: www.nice.org.uk/cg87
- NICE Internal Clinical Guidelines Team. Type 2 diabetes in adults: management. Clinical Guideline Update (NG28). Methods, evidence and recommendations. NICE, 2015. Available at: www.nice.org.uk/guidance/ng28/evidence
- NICE. Cardiovascular disease: risk assessment and reduction, including lipid modification. NICE Guideline 181. NICE, 2014. Available at:www.nice.org.uk/cg181
- NICE. Myocardial infarction: cardiac rehabilitation and prevention of further MI. NICE Clinical Guideline 172. NICE, 2013. Available at: www.nice.org.uk/cg172
- NICE. Diabetes in pregnancy: management from preconception to the postnatal period. NICE Guideline 3. NICE, 2015. Available at:www.nice.org.uk/ng3
- NICE. Canagliflozin in combination therapy for treating type 2 diabetes. NICE Technology Appraisal 315. NICE, 2014. Available at:www.nice.org.uk/ta315
- NICE. Dapagliflozin in combination therapy for treating type 2 diabetes. NICE Technology Appraisal 288. NICE, 2013. Available at:www.nice.org.uk/ta288
- NICE. Empagliflozin in combination therapy for treating type 2 diabetes. NICE Technology Appraisal 336. NICE, 2015. Available at:www.nice.org.uk/ta336
- NICE. Diabetic foot problems: prevention and management. NICE Guideline 19. NICE, 2015. Available at: www.nice.org.uk/ng19
- NICE. Neuropathic pain in adults: pharmacological management in non-specialist settings. NICE Clinical Guideline 173. NICE, 2013. Available at: www.nice.org.uk/cg173
- NICE. Chronic kidney disease in adults: assessment and management. NICE Clinical Guideline 182. NICE, 2014. Available at:www.nice.org.uk/cg182