FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2043252178> ?p ?o ?g. }

• W2043252178 endingPage "4" @default.
• W2043252178 startingPage "1" @default.
• W2043252178 abstract "In July 2008, the UK National Institute for Health and Clinical Excellence (NICE) published a review and re-appraisal (ref. TA151) of their guidance on continuous subcutaneous insulin infusion (CSII, insulin pump therapy) [1]. This replaces the NICE Technology Appraisal Guidance 57 issued in February 2003 [2]. In brief, the revised guidance is that CSII is recommended as a treatment option in Type 1 diabetes for: adults and children ≥ 12 years of age when either: Attempts to achieve target HbA1c levels with multiple daily insulin injections (MDI) result in disabling hypoglycaemia, or HbA1c levels have remained high on MDI (≥ 8.5%) despite a high level of care children < 12 years old when: MDI is considered to be impractical or inappropriate, and with the expectation that children would be expected to undergo a later trial of MDI between the ages of 12 and 18 years. There are two major policy changes in these new guidelines. The first is the introduction of a new category of patients with Type 1 diabetes who may be suitable for a trial of CSII: those with a persistently elevated HbA1c (NICE have chosen a cut-off HbA1c of ≥ 8.5%) during best attempts to control their diabetes with MDI. The second main change is the recommendation that children no longer need to have ‘failed on MDI’ before undertaking a trial of CSII. The phrase ‘failed on MDI’, a notoriously controversial concept from the 2003 Guidance, has now been removed from the revised version. Many healthcare professionals involved in the care of children with diabetes, as well as parents and children themselves, have argued that MDI is not practical in many children. A child with diabetes at school may be unable, unwilling or prevented from injecting insulin, and restricted from attending school trips and other activities because of the need to inject. Parents may even have to attend school to give the child a lunch-time injection as part of an MDI regimen. This recommendation will therefore be widely welcomed, and will encourage greater use of CSII in children, which in the UK has lagged behind that in adults with Type 1 diabetes and far behind that in some paediatric diabetes centres in other countries. The requirement that children started on CSII (who would not yet have been treated by MDI as a result of the revised Guidance) should subsequently undergo a trial of MDI at some time between the ages of 12 and 18 years will be unpopular with many. It was included because of the initial lack of guidance about continuation of CSII when children reach adolescence and adulthood. It is clear that the Committee were aware of the problems that might be encountered when changing the regimen in a teenager with well-controlled diabetes on CSII and risking metabolic and emotional upset if MDI were not to match the control of pump therapy. Indeed, this would be at a time (as the Guidance says) already associated with substantial ‘developmental, social and educational changes’. Careful reading of the Appraisal and the Consultation Document that accompanies it extracts the information that: such a trial of MDI ‘would normally need to be undertaken’; the Guidance ‘allows for the intervention to be tailored to an individual’; and that ‘all NICE guidance comes with the caveat that an individual physician can allow for exceptions on clinical grounds’. In our view, whilst noting the generally recommended approach to trialling MDI, the physician may consider that the clinical, psychological and social circumstances of an individual patient may sometimes indicate that a switch to MDI would not be advisable. This indication arises from lines of clinical evidence that have become apparent since the original appraisal 5 years ago. Although it was originally thought that the difference in HbA1c in people with Type 1 diabetes treated by either MDI or CSII is relatively modest, on average about 0.5%[3,4], it is now known that there is a more marked lowering of HbA1c on switching to insulin pump therapy in those patients with a high HbA1c on MDI, i.e. CSII is most effective in the most poorly controlled patients [5–8]. For example, those with an HbA1c > 10.0% can achieve an improvement of up to 3–4% when treated by CSII. This evidence on the efficacy of CSII is supported by data from individual patients in randomized controlled trials (RCTs) [8] and insulin pump clinics [6,7], and by a recent meta-analysis and metaregression of 22 RCTs and observational studies comparing glycaemic control (and severe hypoglycaemia) during MDI and CSII [5]. Interestingly, the NICE Assessment Group noted that although observational studies, which outnumber RCTs, carried a greater risk of bias than the RCTs, they were mostly of longer duration and more representative of the type of patients likely to be treated by CSII in routine clinical practice. Modern MDI therapy encompasses not only a basal-bolus insulin injection regimen, including the use of long-acting insulin analogues and monomeric short-acting insulin as appropriate, but also frequent blood glucose self-monitoring and insulin dosage adjustment, structured patient education with dietary advice and frequent contact with healthcare professionals. Glycaemic control has undoubtedly been dramatically improved as the result of the introduction of MDI, especially in the most motivated patients. However, numerous research studies and common clinical experience show that 15–20% of people on MDI still maintain an elevated HbA1c, say > 9.0%[6,9]. One of the main determinants of high HbA1c on injection therapy is high glycaemic variability [6], and such patients probably maintain an elevated HbA1c in order to avoid hypoglycaemia that will inevitably emerge as attempts are made to tighten control. As routine clinics for insulin pump therapy have became established in recent years, it became apparent from clinical audits that, contrary to expectation, many patients referred for a trial of CSII because of frequent severe hypoglycaemia during MDI had an elevated HbA1c as a presenting problem, sometimes without much hypoglycaemia [10]. The choice by NICE of an HbA1c≥ 8.5% as being the level of poor control at which CSII should be considered was the main point at issue during the consultation phase of the Appraisal, with > 90% of comments and objections referring to this level. Many have erroneously taken the level of 8.5% to mean the target HbA1c that NICE recommends for Type 1 diabetes management, but rather it is the level above which NICE judged CSII to be cost effective, in the absence of disabling hypoglycaemia. In practical terms, those patients being considered for CSII because of continued unacceptable control during MDI who have an HbA1c below this level are likely also to suffer from disabling hypoglycaemia, so the seemingly arbitrary or debatable cut-off at 8.5% HbA1c probably will not be a barrier to trialling insulin pump therapy in such people under NICE criteria. In continuing the recommendation first established in the 2003 Guidance [2] that disabling hypoglycaemia during MDI should be an indication for CSII, the Appraisal Committee for the revised Guidance took into account the now very strong evidence base that all grades of hypoglycaemia are reduced by switching from MDI to CSII. A recent meta-analysis of 22 studies reported in this journal [5], which was considered by the Committee, compared the frequency of severe hypoglycaemia during MDI and CSII, and was restricted to studies using modern insulins, modern pumps and trials where pump therapy was of ≥ 6 months’ duration. Switching from MDI to CSII in these trials reduced the rate of severe hypoglycaemia by an average of 75% (rate ratio 4.19, 95% confidence interval 2.86, 6.13), with no significant difference between RCTs and observational studies. As with HbA1c, the biggest improvement in severe hypoglycaemia occurred in those with most hypoglycaemia during MDI, where the hypoglycaemia frequency can be 10–20-fold less when subjects were treated by CSII as opposed to MDI. An interesting note is that the description in the 2003 guidance of disabling hypoglycaemia as that ‘requiring third-party assistance’ (the common definition of severe hypoglycaemia [11]) has been removed from the 2008 revision. Disabling hypoglycaemia is now the ‘repeated and unpredictable occurrence of hypoglycaemia that results in persistent anxiety about recurrence and associated with significant adverse quality of life’. This change should thereby include the large numbers of people with varying degrees of hypoglycaemia that substantially impair quality of life. One of the largest and most detailed sections of the appraisal concerned the cost effectiveness (CE) of CSII vs. MDI, and the NICE committee not only took evidence and considered new CE analyses from the Association of British Healthcare Industries (ABHI) (which includes representation from the insulin pump manufacturers) but also performed its own evaluation, via the Aberdeen Health Technology Assessment Group. Amongst the points that were reviewed were the evidence from studies on CE of CSII that have been published since the 2003 guidance [12,13], new information on the expected reduction in hypoglycaemia by pumps [5] and the greater HbA1c improvement in the initially most poorly controlled patients [5–8], and thus the probably greater than previously expected effect on reduction in complications and thus CE. Both the manufacturers’ and the NICE assessments of CE were, as expected, clearly dependent on the baseline HbA1c, with an incremental CE ratio (ICER) varying from £16 842 to £34 330 per quality-adjusted life-year (QALY) gained (ABHI), and the Assessment Group from £24 720 to £37 712 per QALY gained, depending on the baseline HbA1c and assumed reduction in HbA1c with pump therapy. NICE agreed that CSII is most effective at improving glycaemic control at higher initial HbA1c levels on MDI and therefore most cost effective, because the risk of microvascular complications increases disproportionately at this level. However, based on HbA1c alone, NICE judged that pump treatment was not cost effective at HbA1c much below 9.0% on MDI unless quality of life improvements, not captured in the modelling, were included. Based on the accumulating evidence that quality of life is significantly better on CSII vs. MDI [14,15], this is a plausible calculation and accounts for the guidance that CSII is a cost-effective use of resources when HbA1c remains ≥ 8.5% on MDI. NICE noted that there was apparently little alteration in the CE when varying rates of hypoglycaemia reduction were used in sensitivity analyses. An obvious problem with CE estimates is that many or most episodes of hypoglycaemia are cost neutral, and relatively few incur the cost of a hospital visit or other medical attention. Such episodes are nevertheless profoundly damaging to the quality of life of patients, and the committee tried to factor this into the CE analysis, judging that avoiding hypoglycaemia and the associated reduced fear of this complication might result in an increase in quality of life: a 0.01 increase would decrease the ICER to £29 300 and a 0.03 increase in quality of life to £21 000 per QALY gained. Apparently, no account was taken of death due to hypoglycaemia in any of the analyses or of the cost implications of reducing mortality by switching to CSII. Taken together, the conclusion of these calculations is that CSII is a cost-effective use of resources for the two clinical indications of elevated HbA1c and disabling hypoglycaemia during MDI. Other notable points in the 2008 Guidance are: CSII should be continued only if there is sustained improvement in HbA1c or hypoglycaemia rate. This follows from the observation that, although with proper selection and adherence to guidance on indications most patients experience marked and persistent benefit from insulin pump therapy, a few patients do not. As a costly resource, CSII should be reserved for those who show clear and maintained improvement in control. NICE sensibly considers that the targets for HbA1c or hypoglycaemia improvement, the length of the trial period for obtaining these goals and the period over which levels should be maintained should be set on an individual basis, determined and agreed together by the healthcare team, pump user or carer. It is worth noting that a period of pump re-education (a ‘refresher course’) can sometimes restore good glycaemic control and avoid pump withdrawal in patients who have deteriorating control after a year or so on CSII. As for the 2003 Guidance, it is still recommended that CSII is initiated by a trained specialist team, although the exact composition of this team is left to the individual centre. Normally, this grouping would include at least a diabetes physician with a special interest in insulin pump therapy, and a diabetes specialist nurse and dietician trained in insulin pump procedures. As for the 2003 Guidance, CSII is still not recommended for Type 2 diabetes. This recommendation was based on the absence of clear RCT evidence that HbA1c differs in people with Type 2 diabetes allocated to either MDI or CSII [16–18]. Interestingly, the Assessment Group acknowledges that there may be subgroups of people with Type 2 diabetes who might benefit from CSII: there are several anecdotal reports of Type 2 diabetic patients with difficult-to-control diabetes who have been markedly improved on switching to CSII [19]. However, NICE notes that there is insufficient evidence in this area at the moment, and concludes that CSII cannot be recommended as a cost-effective use of NHS resources at this time. In the details of the clinical evidence considered by the Appraisal Committee, the use of CSII in pregnancy is discussed. The conclusion reached, supported by two recent meta-analyses, is that CSII does not offer any additional advantages over MDI in diabetic pregnancy. However, when considering CSII in pregnant women with Type 1 diabetes, the NICE guidance on Diabetes in Pregnancy [20] recommends that use of CSII may be indicated when the target HbA1c of ≤ 6.1% preconceptually or in the first trimester cannot be achieved without the occurrence of disabling hypoglycaemia. This is consistent with the 2008 Guidance on CSII, while acknowledging the tighter control required during pregnancy. The 2003 NICE Guidelines estimated that 1–2% of people with Type 1 diabetes in the UK would be ‘appropriate for’ treatment by CSII [2]. This range, which was not supported by any evidence in that document and was probably intended as an indication of the approximate initial uptake of insulin pump therapy, was widely misinterpreted as the percentage of patients who would be expected to benefit from pump therapy and used by some Primary Care Trusts in the UK as a cap on CSII use at that level. The revised Guidance itself does not make an estimate of likely use, and the Appraisal Committee now considers that ‘it is outside the remit of an appraisal to recommend what proportion of people with diabetes who would go on pumps should be’. However, a Costing Template, which has been issued at the same time as the Guidance and which is aimed at helping health organizations to plan the financial implications of the revised Guidance [20], has used an estimated uptake of CSII of 10% of people > 12 years old with Type 1 diabetes (since expert opinion varies from about 8 to 15%), and an uptake of 25% in children with Type 1 diabetes < 12 years old (since expert opinion varies from about 15 to 50%). Both of these figures are substantially higher than the present usage of CSII in the UK, which NICE puts at < 4%. The evidence base for estimating the percentage of people with Type 1 diabetes likely to benefit on clinical grounds has been discussed recently and estimated at about 15–20%[9]. The revised Guidance on CSII is the result of a comprehensive review and balanced assessment of the evidence base on the appropriate use of insulin pump therapy. The additional clinical indication of an elevated HbA1c on MDI and the new recommendations for children should ensure that many more people with Type 1 diabetes who stand to benefit from CSII are offered a trial of this therapy. The challenge now will be to implement the Guidance and to reduce the variability in access to CSII that has occurred throughout the UK in recent years. Commissioners of diabetes services will want to read the Guidance in conjunction with the NICE Costing Template for CSII [21] and the recent Department of Health and Diabetes UK Insulin Pump Working Group Report [22], which offers valuable advice on organizing insulin pump services. J.C.P. and P.H. have received speaker or consultancy fees from Medtronic, LifeScan and Roche Ltd, manufacturers of insulin pumps." @default.
• W2043252178 created "2016-06-24" @default.
• W2043252178 creator A5024814684 @default.
• W2043252178 creator A5055671611 @default.
• W2043252178 date "2009-01-01" @default.
• W2043252178 modified "2023-10-09" @default.
• W2043252178 title "NICE guidance on continuous subcutaneous insulin infusion 2008: review of the technology appraisal guidance" @default.
• W2043252178 cites W1490382590 @default.
• W2043252178 cites W1965722550 @default.
• W2043252178 cites W1991835641 @default.
• W2043252178 cites W2017021920 @default.
• W2043252178 cites W2017930048 @default.
• W2043252178 cites W2021831716 @default.
• W2043252178 cites W2024679311 @default.
• W2043252178 cites W2037385875 @default.
• W2043252178 cites W2065182422 @default.
• W2043252178 cites W2107926840 @default.
• W2043252178 cites W2108855260 @default.
• W2043252178 cites W2131439934 @default.
• W2043252178 cites W2135131610 @default.
• W2043252178 cites W2140147198 @default.
• W2043252178 cites W2141452347 @default.
• W2043252178 cites W2158957841 @default.
• W2043252178 cites W2190748907 @default.
• W2043252178 doi "https://doi.org/10.1111/j.1464-5491.2008.02617.x" @default.
• W2043252178 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/19125753" @default.
• W2043252178 hasPublicationYear "2009" @default.
• W2043252178 type Work @default.
• W2043252178 sameAs 2043252178 @default.
• W2043252178 citedByCount "34" @default.
• W2043252178 countsByYear W20432521782012 @default.
• W2043252178 countsByYear W20432521782013 @default.
• W2043252178 countsByYear W20432521782014 @default.
• W2043252178 countsByYear W20432521782015 @default.
• W2043252178 countsByYear W20432521782016 @default.
• W2043252178 countsByYear W20432521782017 @default.
• W2043252178 countsByYear W20432521782019 @default.
• W2043252178 countsByYear W20432521782021 @default.
• W2043252178 crossrefType "journal-article" @default.
• W2043252178 hasAuthorship W2043252178A5024814684 @default.
• W2043252178 hasAuthorship W2043252178A5055671611 @default.
• W2043252178 hasBestOaLocation W20432521781 @default.
• W2043252178 hasConcept C126322002 @default.
• W2043252178 hasConcept C177713679 @default.
• W2043252178 hasConcept C199360897 @default.
• W2043252178 hasConcept C2779256446 @default.
• W2043252178 hasConcept C2779306644 @default.
• W2043252178 hasConcept C41008148 @default.
• W2043252178 hasConcept C71924100 @default.
• W2043252178 hasConceptScore W2043252178C126322002 @default.
• W2043252178 hasConceptScore W2043252178C177713679 @default.
• W2043252178 hasConceptScore W2043252178C199360897 @default.
• W2043252178 hasConceptScore W2043252178C2779256446 @default.
• W2043252178 hasConceptScore W2043252178C2779306644 @default.
• W2043252178 hasConceptScore W2043252178C41008148 @default.
• W2043252178 hasConceptScore W2043252178C71924100 @default.
• W2043252178 hasIssue "1" @default.
• W2043252178 hasLocation W20432521781 @default.
• W2043252178 hasLocation W20432521782 @default.
• W2043252178 hasOpenAccess W2043252178 @default.
• W2043252178 hasPrimaryLocation W20432521781 @default.
• W2043252178 hasRelatedWork W1506200166 @default.
• W2043252178 hasRelatedWork W1995515455 @default.
• W2043252178 hasRelatedWork W2048182022 @default.
• W2043252178 hasRelatedWork W2080531066 @default.
• W2043252178 hasRelatedWork W2604872355 @default.
• W2043252178 hasRelatedWork W2748952813 @default.
• W2043252178 hasRelatedWork W2899084033 @default.
• W2043252178 hasRelatedWork W3031052312 @default.
• W2043252178 hasRelatedWork W3032375762 @default.
• W2043252178 hasRelatedWork W3108674512 @default.
• W2043252178 hasVolume "26" @default.
• W2043252178 isParatext "false" @default.
• W2043252178 isRetracted "false" @default.
• W2043252178 magId "2043252178" @default.
• W2043252178 workType "article" @default.