Diabetes in children & young people (NICE 2015)

Given the epidemiology of diabetes, most Health Care Professionals spend a significant amount of time treating Type 2 adult patients, often at the expense of a very vulnerable group of patients, specifically young people. The epidemiology of diabetes in this group is also changing as, due to the rise in obesity, it is increasingly common to see a young person with Type 2 diabetes. As a result, it is timely that NICE has published guidance for this group of patients, an update from their original 2004 document. In fact, early in their guidance, the possibility of Type 2 diabetes is raised at time of diagnosis in certain groups including patients of S Asian origin or show signs of insulin resistance (e.g. acanthosis nigricans). There is also increasing recognition of different sub types of diabetes e.g. monogenic with advice around genetic testing and C-peptide measurement. Whilst most children will be managed in secondary care, there are several developments within this guidance which will impact on service delivery. Specifically, this includes enhanced patient (and family) education, a requirement to attend clinic 4 times per year as well as further advice on retinal screening. There is some advice on transition from paediatric to adult care although given the importance of this period, guidance is surprisingly brief especially the potential benefits of psychological services in diabetes care. The lack of recommendations about transition contrasts with the large detailed description on ketoacidosis management, despite DKA guidance being a summary of recommendations from the Joint British Diabetes Societies.

Unsurprisingly, the main sections refer to glycaemic control including targets and drug use. An HbA1c<48mmol/mol (6.5%) is recommended and although an individualised target is suggested, special reference is given to those whose HbA1c is>53mmol/mol. Glycaemic targets have been divided into the management of both T1 and T2 patients. For both, a patient centred approach is advised but a basal bolus regimen is recommended as first line with pump therapy another early option especially if good control is not possible. Obviously dietary modification including carbohydrate counting is required – assuming dietetic services are adequate. As a contrast to T1 management in adults, Metformin is not recommended due to lack of evidence yet the sustained release preparation is considered first line in children with T2 diabetes.  Guidelines for this group of patients are the most significant change since 2004 in recognition of their growing number with extensive advice given about lipid, blood pressure and renal complications.

Overall, this new and updated guidance in an important patient group from NICE is welcome however, as ever, the challenge will be its implementation especially those sections where funding and service delivery need addressing.

Dr Mark Freeman

October 2015

https://www.glycosmedia.com/9591-2/

Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes

Bernard Zinman et al. NEJM. Doi: 10.1056/NEJMoa1504720

 

The withdrawal of rosiglitazone from European markets, following the suggestion that it increased the risk of myocardial infarction in people with type 2 diabetes (T2DM), spawned a generation of cardiovascular outcome trials (CVOTs) for new diabetes therapies. CVOTs are designed to be safety studies, aiming for so-called ‘glycaemic equipoise’; this means that any reduction in HbA1c should be similar in patients receiving the new, active therapy to those receiving placebo. They also have other facets, which make them unlikely to demonstrate CV benefit; they are usually short studies (2-3 years); they often focus on patients with advanced CV disease (where glycaemic control is least likely to provide advantage, and may cause harm) and they mandate optimal control of other CV risk factors (such as blood pressure [BP] and low-density lipoprotein cholesterol). For these reasons, many assumed that CVOTs would show no evidence of harm but also no evidence of superiority. This was largely the case for three studies, which examined the dipeptidyl peptidase-4 inhibitors (saxa-, alo- and sitagliptin) and the ELIXA trial of lixisenatide.

 

Imagine then, the surprise when results of the EMPA-REG study were presented at the European Association for the Study of Diabetes (EASD) meeting in Stockholm in September 2015. Not only did this CVOT of the sodium glucose co-transporter-2 (SGLT-2) inhibitor, empagliflozin, show a significant reduction in the primary end-point of ‘CV death, non-fatal myocardial infarction or non-fatal stroke’ but there was also a significant reduction in all-cause mortality. The patient cohort was at extremely high CV risk, with median treatment duration of only 3.1 years and benefits were seen within three months of the drug initiation.

 

Explanation of this unexpected finding will generate more studies, no doubt with focus on non-glycaemic effects of SGLT-2 inhibitors (such as BP and weight reduction and their diuretic action). It will also be of great interest to see if the other two SGLT-2 inhibitor CVOTs show similar results, although they will not complete until after 2017.

http://www.nejm.org/doi/full/10.1056/NEJMoa1504720

 

Professor Steve Bain

October 2015

https://www.glycosmedia.com/9589-2/

 

Diabetes care is often a trade off between tighter glucose control and hypoglycaemia (blood glucose <4.0mmol/l). Whilst clinicians often appear to concentrate on the former, hypoglycaemia is the one aspect of diabetes care that concerns patients. Hypoglycaemia occurs more commonly than is usually thought, 10-30% of patients with Type 1 diabetes having a severe episode each year. In Type 2 diabetes, the risk of hypoglycaemia depends on the duration of diabetes and the increasing use of insulin.

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Following the controversial structural changes incorporated in the 2012 Health and Social Care bill, both health care professionals and patients could be forgiven for thinking that a quieter time of consolidation would be a good idea. However, this is the NHS where the mantra ‘change is good’ seems to be its mission statement. With much less fanfare than the structural changes, new models of care are being introduced across the country which potentially could see radical change to how care is delivered as a way of facing up to an ageing population with increasing long term conditions and at the same time trying to save £22bn over this parliament.

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The UK is currently bracing itself for the launch of clinical guidelines (CGs) from NICE for the management of both type 1 (T1) and type 2 diabetes (T2DM). Notwithstanding any massive changes to the latest drafts, the approach of NICE to basal insulin seems to be inconsistent and represents a missed opportunity to make a real impact.

T1DM in the UK is largely managed by secondary care, especially at the point of diagnosis and therapy initiation. So, when the ‘Type 1 diabetes in adults’ CG gives advice on basal insulin treatment, it is doing so to specialist clinicians who probably think they know what they are doing. That the advice is based on a ‘network meta-analysis’ will cut little ice with specialists, especially when the recommended use of twice-daily basal analogue is at odds with their routine practice.

Contrast this scenario with the advice regarding basal insulin use in T2DM. Here one might anticipate the involvement of non-specialists in primary care – clinical teams who really could benefit from specific advice on insulin use. And yet the current ‘Type 2 diabetes in adults’ CG comes up with “offer NPH insulin injected once or twice daily according to need’ and “consider twice-daily pre-mixed (biphasic) human insulin (particularly if HbA1c is 75 mmol/mol [9.0%] or higher)”. Reference to the BNF will lead the prescriber to five different ‘isophane insulins’ and four human biphasics, all to be dosed ‘according to requirements’. NICE then directs the prescriber to the “insulin delivery section in the NICE guideline on type 1 diabetes. [new 2015]” for further guidance (i.e. how much to inject, when, where and how to titrate…)

The average HbA1c at insulin initiation in the UK is around 10% (84mmol/mol), this being preceded by years of so-called clinical inertia. Following initiation, patients are sub-optimally dosed, despite the widespread publication of simple, patient-managed titration algorithms. And NICE, on one hand, makes no reference to any of these issues, but on the other is dictating to specialists. I think someone has lost the plot….

Professor Steve Bain

The SGLT2 inhibitors are the newest class of hypoglycaemic agents and have been used increasingly frequently because of their efficacy, oral route of administration and added effects of weight loss and a small but significant reduction in blood pressure. Their insulin independent mode of action has meant that they can be used irrespective of β cell mass and therefore are not limited to early in the pathogenesis of T2DM. The side effect profile is well recognised with urogenital infections the most obvious (although relatively infrequent in clinical practice). However, recently, there have been reports of ketoacidosis in patients on these drugs. As of mid May 2015, the European Medicines Authority have reported a total of 101 cases of diabetic ketoacidosis in patients treated with SGLT2 inhibitors for type 2 diabetes.

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‘The streetlight effect in type 1 diabetes’ is an intriguing article published earlier this year in the journal ‘Diabetes’. http://diabetes.diabetesjournals.org/content/64/4/1081.full

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Cardiovascular (CV) safety trials in type 2 diabetes (T2DM) are a bit like London buses; you wait for what seems like an age and then two of them come along at once. So it was at the American Diabetes Association (ADA) meeting in June where the results of the TECOS and ELIXA studies were presented.

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The epidemic of type 2 diabetes (T2DM) is widely attributed to rising levels of obesity, which in turn are attributed to lifestyle issues (diet and exercise).  So, at best, it’s society’s fault and, at worst, we get to blame each individual patient.

But surely there must be more to it that this? Every practicing clinician has patients with T2DM who are not overweight and, not only are the majority of people with so-called ‘morbid obesity’ non-diabetic, a significant proportion of them have normal insulin sensitivity (i.e. they don’t manifest insulin resistance, which is the way that obesity is meant to drive the increase in T2DM). Furthermore, the inexorable decline in beta-cell function, so clearly demonstrated by the UKPDS, seems to be reversible not only using glucagon-like peptide-1 (GLP-1) injectable therapies but more remarkably by malabsorptive bariatric surgical procedures. This has made various groups question the current thinking around the pathophysiology of T2DM, with a particular focus on the bowel.

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Insulin is responsible for a significant number of prescribing errors within the NHS despite this being listed as a ‘never event’ in 2011/12. In fact, the national diabetes in patient audit suggests that errors occur in one third of hospital patients.

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The patient with diabetes presenting with a hot foot is not an uncommon event for all health care professionals, based in either primary or secondary care and whether they have an interest in diabetes or not. There does seem to be a knee jerk reaction to these patients where infection is considered as the only likely cause yet failure to respond to antibiotics does not always ring alarm bells of another chronic and serious condition, the Charcot foot.

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In January 2015, the position statement of the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) on management of hyperglycaemia in type 2 diabetes (T2DM) was updated. The consensus document recognises an “increasing array of antihyperglycemic drugs” with uncertainty regarding selection and sequence due to “a paucity of comparative effectiveness research on long- term treatment outcomes”. As previously, the authors argue for individualisation of HbA1c targets and treatment strategies, and sanction use of any class of anti-diabetic therapy as second-line after metformin.

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Pregnancy poses additional risks for women with diabetes. The most recent CEMACH (Confidential Enquiry into Maternal and Child Health) report continues to show that babies of women with diabetes are five times as likely to be stillborn, three times as likely to die in their first months of life and twice as likely to have major congenital malformation (this last number maybe higher as it is not adjusted for the higher rate of terminations where congenital malformations are found). Although the majority of mothers with pre-existing diabetes have type 1 diabetes, the proportion of births to women with diabetes is rising due to the rising numbers of young women with Type 2 diabetes. Worryingly, some of the latter group are only diagnosed in pregnancy.

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