Professor Roger Gadsby reviews proposed updates to the NICE guideline on type 2 diabetes in adults and the areas of concern
Read this article to learn more about:
- the delays to the publication of the NICE guideline on type 2 diabetes in adults
- the controversial recommendations in the draft guidance.
NICE Clinical Guideline (CG) 87 on Type 2 diabetes: the management of type 2 diabetes,1 published in 2009, is undergoing an update. The guideline development group for the update has been working over the past couple of years and published the first consultation draft of the new guideline in January 2015 for stakeholder comment.2
This initial draft was commended for its recommendations on lifestyle advice, patient education, monitoring, and targets, but heavily criticised for its recommendations on glycaemic lowering,3 which some experts have described as 'bonkers'.4
In light of this, the guideline development group revisited the glucose-lowering recommendations and published a second draft of the guideline in summer 2015, again for stakeholder comment.5 This version has been described by some as having some positive changes from draft 1 but still not being 'fit for purpose'.6 The criticisms outlined continue to be focused on the glycaemic-lowering recommendations.
In this Guidelines in Practice article, the author summarises the principal recommendations from the second draft of the updated guideline5 and highlights areas of concern.
The main recommendations
The principal recommendations in the second guideline draft5 are summarised below, followed by the author's comments.
- Offer structured education to adults with type 2 diabetes and/or their family and carers (as appropriate) at and around the time of diagnosis, with annual reinforcement and review. Explain to people and their carers that structured education is an integral part of diabetes care
- Ensure that any structured education programme for adults with type 2 diabetes includes the following components: [which are then listed in detail].5
- Integrate dietary advice with a personalised diabetes management plan, including other aspects of lifestyle modification, such as increasing physical activity and losing weight.5
This again puts lifestyle modification at the heart of diabetes management, and features as one of the key recommendations of the guideline.
- Involve adults with type 2 diabetes in decisions about their individual HbA1c target ...
- In adults with type 2 diabetes that is managed either by lifestyle and diet, or by lifestyle and diet in combination with a single drug that is not associated with hypoglycaemia, agree a target and aim for an HbA1c level of 48 mmol/mol (6 .5%)
- ... if HBA1c levels ... rise to 58 mmol/mol (7.5%) or higher, reinforce advice about diet, lifestyle and adherence ... and intensify drug treatment, and agree a target ... of 53 mmol/mol (7%).5
The targets are slightly less tight than the ones from 2009 when the recommendation then was to add a second oral agent if the HBA1c on one oral agent rose to 48 mmol/mol (6.5%) or above. There are also recommendations to consider relaxing targets on a case-by-case basis in people:
- with reduced life expectancy
- with significant comorbidities
- who are older or frail
- with impaired awareness of hypoglycaemia
- who drive or operate machinery as part of their job.
Blood pressure management
- Add medications if lifestyle advice does not reduce blood pressure to below 140/80 mmHg (below 130/80 mmHg if there is kidney, eye or cerebrovascular damage)
- Monitor blood pressure every 1–2 months, and intensify therapy ... until the blood pressure is consistently below 140/80 mmHg (or 130/80 mmHg if there is kidney, eye, or cerebrovascular damage).5
These recommendations, and the classes and order of medications recommended, are the same as in 2009.
Self-monitoring of blood glucose
- Do not routinely offer self-monitoring of 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 planning to become pregnant.5
This recommendation if enacted would reduce or stop much of the current blood glucose self-monitoring that is routinely carried out by people who are controlled by lifestyle measures alone or who are on glucose-lowering therapies that have a very low propensity to cause hypoglycaemia (i.e. they are on a therapy other than insulin or sulphonylurea-type medications). This recommendation has been criticised for not allowing patients to identify failure in drug treatment fast enough.6 In the author's opinion it presents an opportunity to reduce inappropriate self-monitoring, which could play a part in reducing the overall medical costs associated with diabetes.
- Offer standard-release metformin as the initial drug treatment for adults with type 2 diabetes
- If an adult with type 2 diabetes experiences gastrointestinal side-effects with standard-release metformin, consider a trial of modified-release metformin.5
This latter recommendation was missing from the first draft2 and drew criticism for its absence.3 The recommendation was included in the 2009 guideline; however, the current guideline development group did not consider any new evidence so the recommendation should have been automatically carried forward. The second draft5 corrects their omission.
- In adults with type 2 diabetes, if metformin is contraindicated or not tolerated, consider initial drug treatment with a dipeptidyl peptidase-4 (DPP-4) inhibitor or pioglitazone or repaglinide or a sulphonylurea.5
The first draft of the updated guideline2 recommended repaglinide as the initial therapy if metformin could not be used. This was criticised as repaglinide is associated with an increased risk of hypoglycaemia and weight gain, and its inclusion in the second draft as a second-line therapy alongside other options has attracted further criticism.6
Other issues associated with repaglinide use include the need for self-monitoring of blood glucose, and for it to be started at a low dose and up-titrated every 2 weeks after a visit to a healthcare professional. The medication is cheap but the costs of using it are potentially very high. It also has a very limited licence so many combinations of repaglinide with another glucose-lowering therapy are 'off licence'. In the author's view repaglinide should just be removed from the guideline.
- If initial treatment with metformin has not continued to control HbA1c to below the person's individually agreed threshold for intensification, consider dual therapy with metformin and pioglitazone, or metformin and a sulphonylurea, or metformin and a DPP-4 inhibitor.5
The guideline states that sodium glucose co-transporter 2 (SGLT2) drugs may be appropriate for some people with type 2 diabetes and refers to the NICE technology appraisals (TAs) for the three currently available therapies in this class (dapagliflozin,9 canagliflozin,10 and empagliflozin11). These recommend SGLT2s as an option at first and second intensification levels. Critics say that these SGLT2 recommendations should be better integrated in the text and should also appear on the glucose-lowering algorithm, which they do not at present.6 The author agrees with this criticism. It does seem strange that the guideline cannot incorporate recommendations from TAs into the text and algorithms at the appropriate places.
- If dual therapy with metformin and another drug has not continued to control HbA1c to below the person's individually agreed threshold for intensification, consider either:
- triple therapy with metformin, pioglitazone and a sulphonylurea, or
- metformin, a sulphonylurea and a DPP-4 inhibitor or
- starting insulin-based treatment
- When starting insulin ... offer NPH insulin once or twice daily according to need
- If triple therapy is not effective, tolerated or is contraindicated, consider combination therapy with metformin, a sulphonylurea and a glucagon-like peptide (GLP-1) mimetic for adults with type 2 diabetes who:
- have a BMI of 35 kg/m2 or higher (adjusted accordingly for people from black, Asian and other minority ethnic groups) and specific psychological problems 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 co-morbidities.5
This whole section has been criticised for its recommendation to offer NPH insulin, rather than the long-acting analogue insulins, which have a longer duration of action and cause less nocturnal hypoglycaemia but are more expensive. It has also been criticised for not recommending more and earlier use of GLP-1 agents (i.e. their use second to metformin or third to a combination of metformin and another glucose-lowering therapy).6 There is the risk that clinicians may feel that these current recommendations regarding the use of NPH insulin and GLP-1 agents will not offer the best options for individual patients and will therefore be ignored.
The second draft of the guideline improves upon the first draft but weaknesses remain in the glucose-lowering section as outlined in this article. The guideline development group is currently reflecting on stakeholder comments on the second draft. The NICE website initially suggested that the guideline would be published in October 2015, then November 2015; it now says December 2015. It would seem that the group is taking longer than expected to consider and perhaps further modify this second draft.
- NICE. Type 2 diabetes: the management of type 2 diabetes. Clinical Guideline 87. NICE, 2009 (modified 2014). Available at: www.nice.org.uk/guidance/cg87 (accessed 23 October 2015).↩
- NICE. Type 2 diabetes in adults: management of type 2 diabetes in adults. NICE Guideline: short version.. Draft for consultation 1. NICE, January 2015. Available at: www.nice.org.uk/guidance/GID-CGWAVE0612/documents/type-2-diabetes-draft-nice-guideline2 (accessed 23 October 2015).↩
- O'Hare J, Miller-Jones D, Hanif W et al. The new NICE guidelines for type 2 diabetes—a critical analysis. Br J Diabetes Vasc Dis 2015; 15 (1): 3–7. Available at: doi.org/10.15277/bjdvd.2015.006 (accessed 23 October 2015).↩
- Price C. NICE risks making itself a 'laughing stock' over guidance on metformin alternatives, say experts. Pulse Today. February 2015. Available at: www.pulsetoday.co.uk/clinical/more-clinical-areas/diabetes/nice-risks-making-itself-a-laughing-stock-over-guidance-on-metformin-alternatives-say-experts/20009139 article (accessed 2 November 2015).↩
- NICE. Type 2 diabetes in adults: management. NICE Guideline: short version. Draft for consultation 2. NICE, June 2015. Available at: www.nice.org.uk/guidance/GID-CGWAVE0612/documents/type-2-diabetes-draft-guideline-nice2↩
- O'Hare J, Hanif W, Millar-Jones D et al. NICE guidelines for type 2 diabetes—revised but still not fit for purpose. Diabet Med 2015; 32 (11): 1398–1403. Available at: doi: 10.1111/dme.12952 (accessed 23 October 2015).↩
- International Diabetes Federation. Clinical Guidelines Task Force. Global guideline for type 2 diabetes. International Diabetes Federation, 2012. Available at: www.idf.org/sites/default/files/IDF-Guideline-for-Type-2-Diabetes.pdf↩
- Scottish Intercollegiate Guidelines Network. Management of diabetes. SIGN 116. Edinburgh: SIGN, 2010. Available at: www.sign.ac.uk/pdf/sign116.pdf↩
- NICE. Dapagliflozin in combination therapy for treating type 2 diabetes. Technology Appraisal 288. NICE, 2013. Available at: www.nice.org.uk/guidance/ta288↩
- NICE. Canagliflozin in combination therapy for treating type 2 diabetes. Technology Appraisal 315. NICE, 2014. Available at: www.nice.org.uk/guidance/ta315↩
- NICE. Empagliflozin in combination therapy for treating type 2 diabetes. Technology Appraisal 336. NICE, 2015. Available at: www.nice.org.uk/guidance/ta336↩G