NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE. Final Appraisal Determination. Continuous subcutaneous insulin infusion for diabetes

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1 NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE 1 Guidance 1.1 Continuous subcutaneous insulin infusion (CSII or insulin pump therapy') is recommended as an option for people with type 1 diabetes provided that: multiple-dose insulin (MDI) therapy (including, where appropriate, the use of insulin glargine) has failed; and those receiving the treatment have the commitment and competence to use the therapy effectively. 1.2 People for whom MDI therapy has failed are considered to be those for whom it has been impossible to maintain a haemoglobin A 1c level no greater than 7.5% (or 6.5% in the presence of microalbuminuria or adverse features of the metabolic syndrome) without disabling hypoglycaemia occurring, despite a high level of self care of their diabetes. Disabling hypoglycaemia, for the purposes of this guidance, means the repeated and unpredictable occurrence of hypoglycaemia requiring third-party assistance that results in continuing anxiety about recurrence and is associated with significant adverse effect on quality of life. 1.3 CSII therapy should be initiated only by a trained specialist team, which should normally comprise a physician with a specialist interest in insulin pump therapy, a diabetes specialist nurse and a dietitian. 1.4 All individuals beginning CSII therapy should be provided with specific training in its use. Ongoing support from a specialist team should be available, particularly in the period immediately following the initiation of CSII. It is recommended that specialist teams should agree a common core of advice Issue date: January 2003 Page 1 of 27

2 appropriate for CSII users. 1.5 The recommendations in this guidance are also applicable to children, adolescents, pre-pregnant and pregnant women for whom MDI therapy is deemed to have failed. Because of the risks of ketoacidosis to the fetus, pregnant or pre-pregnant women who switch to CSII therapy should do so only on the advice and under the care of a specialist team (defined in Section 1.3). 1.6 CSII therapy is not recommended for people with type 2 diabetes who require insulin therapy. 1.7 Established users of CSII therapy should have their insulin management reviewed by their specialist team so that a decision can be made about whether a trial of a switch to MDI incorporating insulin glargine would be appropriate. 2 Clinical need and practice 2.1 Diabetes is a chronic metabolic disorder caused by defects in insulin secretion and action. There are two major types of diabetes, type 1 and type In type 1 diabetes, the pancreas makes little or no insulin because the islet β cells, which produce insulin, have been destroyed through an autoimmune mechanism. Therefore, people with type 1 diabetes usually depend on daily insulin injections to survive. A similar syndrome can result from attacks of pancreatitis, or surgical removal of the pancreas. 2.3 Type 2 diabetes results from failure of insulin production to overcome reduced tissue sensitivity to insulin (known as insulin resistance). Type 2 diabetes is a Issue date: January 2003 Page 2 of 27

3 progressive disease in which insulin production declines as the disease progresses. 2.4 The age-standardised prevalence of diagnosed diabetes is estimated to be 2.23 per 100 men and 1.64 per 100 women. There are just over 1 million people in England and Wales with diagnosed diabetes. Of those, about 80% have type 2 diabetes (750,000 in England and 50,000 in Wales). The incidence of diabetes has been estimated at 1.7 new diagnoses per 1000 population per year (around 85,000 per year in England and 5000 per year in Wales). 2.5 An impaired insulin effect results in increased levels of glucose in the blood (hyperglycaemia), which can, if prolonged, cause microvascular and macrovascular damage in the body. Common complications of diabetes include visual impairment, kidney failure, angina, myocardial infarction, stroke, foot ulceration and erectile dysfunction. 2.6 Two large landmark studies, the Diabetes Control and Complications Trial (DCCT) and the United Kingdom Prospective Diabetes Study (UKPDS) have demonstrated the beneficial effects of maintaining good glycaemic control on the development and progression of diabetic complications in type 1 and type 2 diabetes, respectively. Issue date: January 2003 Page 3 of 27

4 2.7 The principal goals of treatment for diabetes are to prevent acute and late complications and thus to improve quality of life and avoid premature diabetes-associated death. These goals may be achieved through better control of blood glucose levels and through reductions in other macrovascular risk factors. In the assessment of diabetes management, the most important outcome measures are: self-monitored glucose profiles the proportion of people who achieve target blood glucose levels; the target should reflect individual needs, but glycaemic haemoglobin A 1c (HbA 1c ) levels of between 6.5% and 7.5% are generally recommended the prevention of acute episodes of hypoglycaemia and hyperglycaemia a reduction in other macrovascular risk factors, such as dyslipidaemia, high blood pressure and increased weight short-term quality of life, adverse events and treatment tolerance long-term effects on the incidence of diabetic complications, quality of life and mortality. 2.8 Type 2 diabetes can be managed through diet and exercise alone, at least in the early stages. However, it is a progressive disease, and nearly all individuals require oral glucose-lowering drugs after some time. Most people with type 2 diabetes eventually need insulin to maintain satisfactory blood glucose levels. Current treatment guidelines recommend a step-up policy, starting with advice on diet and exercise, adding oral glucose-lowering agents first as monotherapy and then in combination and finally using insulin if blood glucose control deteriorates. 2.9 Insulin is a necessary treatment for type 1 diabetes. There are four main types of insulin preparation: (1) rapid-acting insulin analogues and (2) shortacting insulins, both of which have a relatively fast onset of action and are often used at meal times; (3) intermediate-acting insulins; and (4) long-acting insulins also referred to as basal insulins which have a slower onset and a longer duration of action. The most commonly used insulin regimens are Issue date: January 2003 Page 4 of 27

5 twice-daily injections of a meal-time and a basal insulin together or four or five injections daily of meal-time insulin before the main meals and one or two injections of basal insulin (the meal-time + basal or basal bolus regimen). The timing and frequency of insulin injections depend upon a number of factors, including the type of insulin, the amount and type of food eaten, the person's level of physical activity, experience of hyper- and hypoglycaemia, and the preference of the person and the appropriateness to his or her lifestyle In pregnancy, poor control of blood glucose levels during the first 10 weeks of gestation is thought to have an adverse effect on fetal development, resulting in a higher risk of congenital malformations. In younger children, good control of blood glucose is difficult to attain, partly because intermediate-acting insulins are absorbed too rapidly. In adolescence, lifestyle and attitudes can make maintenance of tight blood glucose control more difficult Living with diabetes requires the diligent monitoring of blood glucose levels, constant attention to diet and, for people receiving insulin therapy, multiple daily injections (a particular issue in the treatment of children). The inflexibility of lifestyle (carbohydrate counting, regular meal times and multiple daily injections) may have a negative impact on quality of life. Insulin and glucose intake have to be carefully balanced to avoid hyperglycaemia or episodes of hypoglycaemia, which can cause weakness, confusion, dizziness, unconsciousness and seizures. The ongoing threat of short-term and longterm complications of diabetes can cause anxiety, fear and depression. Fear of severe hypoglycaemia is common among people with diabetes on insulin therapy and as a result they may deliberately maintain high blood glucose levels or overtreat the early symptoms of hypoglycaemia in an attempt to avert a severe hypoglycaemic attack. Issue date: January 2003 Page 5 of 27

6 3 The technology 3.1 Continuous subcutaneous insulin infusion (CSII) devices are external pumps comprising a programmable pump and insulin storage reservoir to which the patient is continuously connected. 3.2 Insulin is administered to the patient via a needle or cannula inserted under the skin. The pump delivers insulin continuously at a constant or variable basal rate with an additional boost dose delivered at meal times. Currently available insulin pumps are smaller and more reliable than earlier models. 3.3 The objectives of CSII therapy include improved glycaemic control (the mean blood glucose level may be lower and there may be less variation in blood glucose levels and fewer episodes of hypoglycaemia) and a greater degree of flexibility in lifestyle (for example, less rigid mealtimes, ability to do shift work and ability to take part in social activities). CSII therapy may enable people with diabetes to have greater control over their condition, as well as lower anxiety about episodes of hypoglycaemia. 3.4 Adverse events that may be associated with CSII treatment include catheter site infection (which can be prevented by regular change of the infusion cannula and a high order of personal hygiene), blocked cannula tubing, and ketoacidosis due to lack of insulin in cases of pump malfunction. 3.5 The costs of insulin therapy include the costs of the insulin and the equipment to deliver it, and the costs of self-monitoring, patient education and healthcare professional support. The additional cost of CSII therapy compared with multiple dose insulin (MDI) therapy has been estimated to be in the region of 1100 to 1400 per year, depending on the cost of the pump and the expected length of its life. Currently, about 800 people in England and Wales are believed to be using an insulin pump. Some of these people pay for the pumps and consumables themselves, while for others, funding comes from a charity or the NHS. Issue date: January 2003 Page 6 of 27

7 4 Evidence and interpretation The Appraisal Committee (Appendix A) considered evidence from a number of sources (see Appendix B). 4.1 Clinical effectiveness Twenty studies were identified, comprising eight parallel randomised clinical trials (RCTs), nine crossover RCTs and three non-randomised clinical trials comparing CSII and MDI therapy in the treatment of type 1 and type 2 diabetes. Fourteen of these studies compared CSII with MDI therapy in type 1 diabetes, four studies included pregnant women and two studies included adolescents. Type I diabetes Fourteen studies compared CSII with MDI treatment of type 1 diabetes in adults, of which 11 were RCTs and three were non-randomised studies. HbA 1c levels on average were about 0.6 percentage points lower using CSII compared with MDI therapy. The Assessment Group performed a metaanalysis of up to eight studies at various time points between 10 weeks and 1 year, which demonstrated significant improvements at 4 months (when only the randomised studies were included) but not at 6 months A meta-analysis of five studies comparing the dose of insulin administered with CSII and MDI treatment demonstrated that at 4 months patients receiving CSII therapy required approximately 12 units/day less insulin compared with the group receiving MDI therapy, but there was little difference in insulin usage between the two treatment groups in longer-term studies In the eight studies where this was investigated, no consistent difference in body weight was observed between groups receiving CSII or MDI therapy Data on lipid levels were available from three studies but were insufficient for conclusions to be drawn. Issue date: January 2003 Page 7 of 27

8 4.1.6 Patient preference slightly favoured CSII therapy. However, many of these studies used pumps that are now obsolete and this may bias the results against pumps. Additionally, some of the older studies used obsolete basal insulin injections as a comparator, giving a bias in favour of CSII. A reduction in or elimination of episodes of hypoglycaemia due to the use of CSII will tend to raise the average level of glycated haemoglobin. However, the overall effect of CSII is to lower HbA 1c below pre-pump levels. Some of the most recent studies favour CSII. Only one study reported a quality-of-life (QoL) measurement, which showed no significant differences between CSII and MDI therapy The Assessment Group found little difference in the frequency of severe hypoglycaemia between the CSII and MDI treatments in most of the RCTs. A large body of observational studies, however, found significant reductions in the number of hypoglycaemic events with CSII treatment. The subset of patients enrolled into observational studies may have had greater difficulty with glycaemic control than patients enrolled in the CSII arm of RCTs. Pregnancy The Assessment Group identified four parallel RCTs that compared CSII treatment with MDI treatment in pregnancy. No significant difference on glycated haemoglobin levels or birth weight was found between the two treatments. One study found infant mortality to be significantly lower in the CSII treatment group. Adolescents The Assessment Group identified two RCTs comparing CSII therapy with MDI therapy in adolescents up to age 20 years. In one of the studies there was a significant improvement in glycated haemoglobin at 4 months for patients on CSII therapy compared with MDI therapy, and significantly less insulin was required. In the other study, glycated haemoglobin improved from baseline Issue date: January 2003 Page 8 of 27

9 with both CSII and MDI therapy but there were no differences between the treatments A third study in 25 adolescents with poor glycaemic control showed a reduction of around 40% in rates of severe hypoglycaemic episodes in people treated with CSII compared with those treated with MDI. Children In the absence of RCTs comparing CSII and MDI treatment in children, the Assessment Group reviewed information from case series. One abstract reported a reduction in severe hypoglycaemic events from 0.55 to 0.25 per child per year on transfer from MDI to CSII therapy. Poorly controlled type 2 diabetes There was insufficient evidence to draw conclusions from studies comparing the effect of CSII treatment with MDI treatment in patients with type 2 diabetes using insulin. Evidence from patients and experts The Committee considered evidence from the Assessment Report and in person from CSII users, carers of people with diabetes, patient representative organisations and clinical experts. The benefit to the person with diabetes as a result of reductions in glycated haemoglobin, insulin dose needed and episodes of hypoglycaemia with CSII therapy was unclear from the evidence available from the RCTs. Advances in CSII and MDI therapy may reduce the applicability of the earlier studies reviewed in the Assessment Report to the current situation. It was also noted that the patients enrolled into the clinical trials may not have been the patient group that would benefit most from CSII. The patient representative groups and experts reported many examples of major improvements in quality of life with CSII therapy for people with diabetes who were previously unable to satisfactorily control blood glucose levels with MDI therapy, and had had their lives transformed by CSII therapy. Issue date: January 2003 Page 9 of 27

10 They indicated that although MDI therapy may reduce glycated haemoglobin to an acceptable level in many people with diabetes, some people find the treatment suboptimal because it does not regulate glycaemia sufficiently to avoid the unpleasant symptoms of major swings in blood glucose levels and the occurrence of disabling hypoglycaemic attacks. Once transferred to pump therapy, these patients saw a significant improvement in blood glucose levels, experienced less anxiety about hypoglycaemic episodes and found a great improvement in their quality of life because of the increased flexibility of their lifestyle. 4.2 Cost effectiveness No economic evaluation of insulin pumps was found in the literature The Assessment Group considered that too many assumptions were required for cost effectiveness to be measured in terms of cost per quality-adjusted life year gained (CQG). The approach taken was to look at the costs and consequences associated with MDI therapy compared with CSII therapy. The additional cost of CSII therapy compared with MDI therapy is estimated to be between 1100 and 1400 per year, depending on the type of pump and whether it lasts 4 or 8 years. These estimates were made allowing for cost offsets (comprising reduced insulin costs and lower medical costs for adverse events), estimated to be about 130 per year The two manufacturers also produced economic analyses. One manufacturer estimated a cost per quality-adjusted life year (QALY) of 8400 for CSII therapy against MDI therapy. Because of the absence of utility data comparing CSII and MDI therapies, the other manufacturer suggested how great a patient s utility gain would have to be to make CSII therapy cost effective compared with MDI therapy. It was estimated that utility gains of 8 25% and 3 8% would be needed to attain a cost per QALY of 10,000 and 30,000 respectively. Issue date: January 2003 Page 10 of 27

11 4.3 Consideration of the evidence The Committee reviewed the evidence on both the clinical effectiveness and the cost effectiveness of insulin pump therapy, having considered evidence from people with diabetes who require insulin therapy, those who represent them, and clinical experts, on the nature of the condition and the value placed by users on the effects of insulin pump therapy. It was also mindful of the need to ensure that its advice took account of the efficient use of NHS resources The Appraisal Committee considered that the evidence from clinical trials comparing CSII therapy with MDI therapy showed that on the basis of the outcomes measured either CSII therapy is no more effective than MDI therapy or if CSII therapy is more effective, then at best the difference between the two therapies is small. However, it was accepted that some of the evidence was from studies using CSII technology that is now obsolete, which has been combined with evidence using modern pump technology in the comparisons. In addition, many of the people enrolled in the trials were not from the group most likely to benefit from CSII therapy (that is, people with the most erratic control of their blood glucose levels) The Committee also were informed by the Assessment Report, by people using insulin pumps and by clinical experts that for a small subgroup of people with type 1 diabetes who could not achieve adequate glycaemic control with MDI therapy, a much more satisfactory quality of life could be achieved using CSII therapy. The Committee considered the contrast between these reports of clear benefits of CSII therapy by people using insulin pumps and by clinical experts and the evidence from clinical trials. The Committee concluded that CSII therapy was likely to be of benefit to a selected group of people with diabetes who were determined to do everything possible to overcome previously inadequately controlled disease and that this group comprised only a very small proportion of people with type 1 diabetes. Issue date: January 2003 Page 11 of 27

12 4.3.4 The Committee heard evidence about the stringency of requirements necessary for people to use an insulin pump successfully, including maintaining a high order of personal hygiene, blood testing four times a day, estimating carbohydrate and calorie consumption throughout every day, moving the cannula site every 2 to 3 days, and programming the pump. The Committee believed that CSII therapy should be used only by those who are able to make the appropriate commitment to this technology The Committee considered that CSII therapy should be initiated only by a trained specialist team that could assess a patient s suitability for CSII therapy, provide the information necessary for a patient to make an informed choice, and if CSII therapy is initiated provide adequate training and ongoing assistance. This specialist team should include a physician with a specialist interest in insulin pump therapy, a diabetes specialist nurse and a dietitian The Committee considered whether MDI therapy using insulin glargine would affect the need for insulin pump therapy. The Committee concluded that even if appropriate use of insulin glargine allowed MDI users to achieve sufficient control of previously uncontrolled type 1 diabetes to avoid the need for consideration of CSII therapy, it was likely that there would still be some people for whom CSII therapy would be the only means of being able to avoid disabling hypoglycaemia and to lead a more normal life The Committee discussed the definition of failure of MDI and their conclusions form the basis for Section 1.2 of this guidance. The Committee was clear that it is not a failure of MDI therapy if hypoglycaemia occurs because of attempts to reduce blood glucose to levels below those currently generally considered to be optimal to avoid long-term complications of diabetes When considering cost effectiveness, the Committee discussed at length the difficulties of measuring patient utility levels, particularly the determinants of utility involving: Issue date: January 2003 Page 12 of 27

13 anxiety about possible hypoglycaemic events and changes in behaviour associated with it (such as maintaining blood sugar levels that are inappropriately high but which patients feel are necessary to reduce the likelihood of such events), or being unable to plan for the future The only estimate of cost per QALY gained ( 8400) was provided by one of the manufacturers of insulin pumps, but the Committee believed that this was unduly optimistic, as it was based on limited and selected data. The Assessment Group s critique of the manufacturer s analysis noted that a cost per QALY of about 500,000 could have been estimated if pessimistic rather than optimistic assumptions had been made from the evidence available. The Committee had no reliable information about cost effectiveness derived from the formal clinical evidence. The Committee considered, however, that in patients in whom MDI therapy had failed (as detailed in Section 1.2), the use of CSII therapy would be likely to provide an enhancement in quality of life and an improvement of utility score that was at least equivalent to what would be gained by moving from standard insulin regimens to MDI therapy. For a small subgroup of patients the increase in utility may be even greater The Committee s view was that the proportion of people with type 1 diabetes who would be appropriate for, and would take up, insulin pump therapy would be of the order of 1% to 2% of the total. For this small group of people for whom CSII therapy could make a large difference, the following conditions would have to apply for the therapy to be considered cost effective. Issue date: January 2003 Page 13 of 27

14 The diabetes would have to be poorly controlled, as measured by achievement of accepted levels of HbA 1c, using MDI therapy (including a sufficiently long use of insulin glargine, where appropriate, to determine its effectiveness). CSII therapy should provide significantly better control than MDI therapy (with the use of insulin glargine, where appropriate) and prevent the occurrence of disabling hypoglycaemic events The Committee considered that for this specific group of patients the increase in utility would be of the order of or more. On this basis, at a net cost of 1100 per year to the NHS, CSII therapy would be likely to be cost effective. The Committee believed that over time, the demand for pumps may well exceed 1% to 2% of people with type 1 diabetes. However, current evidence suggests that the technology would not be cost effective for people other than those who are clearly defined by the circumstances described in Section The Committee concluded that while children with type 1diabetes had many special problems not faced by adults with the same condition, the general principles underlying the recommendations for use of CSII remained the same. Thus the use of CSII should be determined by the effects on quality of life of the individual child of the balance between fear of episodes of disabling hypoglycaemia and maintaining an appropriate level of HbA 1c The Committee considered that during pregnancy and planned preconception, for those women in whom MDI therapy (including, where necessary, the use of insulin glargine) had previously provided sufficient glycaemic control, the additional tighter and more flexible control of blood glucose and avoidance of hypoglycaemia afforded by CSII therapy might be required. However, the Committee concluded that many such women would eventually return to MDI therapy after their pregnancy and the post partum period. Issue date: January 2003 Page 14 of 27

15 The Committee took account of the potential for increased risk of ketoacidosis, which can occur when an insulin pump fails to deliver insulin. This risk is considered to be very low with current technology in that the pump delivers a warning to the user if insulin infusion fails. Nevertheless, since the fetus of a pregnant woman with type 1 diabetes is more vulnerable to ketoacidosis than the mother, the Committee considered that particular care was needed when making the decision to switch pregnant and pre-pregnant women with type 1 diabetes from MDI to CSII therapy The Committee considered that there was insufficient evidence for the use of CSII therapy in type 2 diabetes. 5 Recommendations for further research 5.1 It is recommended that an RCT should be carried out to compare the use of insulin glargine in MDI therapy with CSII therapy in people with problems of hypoglycaemia or overnight glucose control. The study should include assessment of quality of life. 5.2 The use of CSII therapy for people with type 2 diabetes should be investigated further. 6 Implications for the NHS 6.1 The submission from PUMP (a professional group) estimates that 1-2% of type 1 patients would move to pumps initially but that this would inevitably rise. 6.2 The Assessment Group estimates annual costs to the NHS of 3.5 million if 1% of the population with type 1 diabetes were to use CSII therapy, and 7 million if 2% the population with type 1 diabetes were to do so. 6.3 Considering the possible impact of the use of insulin glargine, the cost of implementation of CSII therapy is likely to be at the bottom end of the range given in Issue date: January 2003 Page 15 of 27

16 6.4 Since insulin pump use is relatively uncommon, there may be insufficient healthcare professionals with the relevant expertise to support new patients, and training would be required. The lack of specialist health professionals such as nurses has been cited as one reason for pump therapy being infrequently used in the UK. 6.5 There are currently two training centres in England that have, to date, trained 300 health professionals. Trusts need to ensure that people for whom pump therapy is considered appropriate can access healthcare professionals with the requisite expertise, by offering training to their diabetes teams and in the interim by arranging referral to centres with the necessary expertise. In the short run, here will be a cost to existing pump centres on account of referrals, and in the longer term, a more widely-diffused cost for additional staff trained in pump therapy. The latter cost is likely to be offset to some degree by savings elsewhere, in the reduction in adverse events requiring emergency services and hospitalisation. 6.6 The Assessment Group provides an estimate of 2715 for the cost of training a team of health professionals (a physician, diabetic nurse specialist and dietitian) in the use of pumps. The manufacturers suggest that this is an overestimate, because 1 day not 3 days is sufficient to train a physician. They estimate the cost to be in the region of Implementation and audit 7.1 NHS Trusts and consultants treating people with diabetes should review policies and practices regarding the treatment of people with diabetes to take account of the guidance set out in Section The cost of ongoing consumables and in due course, replacement pumps, should be funded by the NHS for established CSII users for whom MDI with insulin glargine is considered inappropriate or proves to be inadequate to maintain adequate glycaemic control (see Section 1). Issue date: January 2003 Page 16 of 27

17 7.3 Local guidelines or care pathways on the care of people with diabetes should incorporate the guidance in Section Specialist teams who assume responsibility for initiating CSII should agree a common core of advice appropriate for CSII users in England and Wales. 7.5 To measure compliance locally with the guidance, the following criteria can be used. Further details on suggestions for audit are presented in Appendix C Insulin pump therapy (CSII) is considered as a treatment option for a person with type 1 diabetes for whom MDI therapy has failed, and who has the commitment and competence to use the CSII therapy effectively CSII is initiated only by a trained specialist team which comprises a physician with a specialist interest in insulin pump therapy, a diabetes specialist nurse and a dietitian A person beginning CSII therapy is provided with specific training in its use and has ongoing support from a specialist team, particularly in the period immediately following the initiation of CSII A person on CSII therapy is reviewed by his or her specialist team, who make a decision on whether it is appropriate for the person to undergo a trial of switching to MDI incorporating insulin glargine. 7.6 Local clinical audits on the care of patients with diabetes also could include criteria for the management of diabetes based on the standards in the National Service Framework for Diabetes. 8 Related guidance 8.1 The Institute has issued guidance on the use of rosiglitazone and pioglitazone, and on the use of long-acting insulin analogues for the treatment of diabetes: Issue date: January 2003 Page 17 of 27

18 (2000) Guidance on rosiglitazone for type 2 diabetes mellitus. NICE Technology Appraisal Guidance No. 9. London:. Available from: (2001) Guidance on the use of pioglitazone for type 2 diabetes mellitus. NICE Technology Appraisal Guidance No. 21. London:. Available from: (2002) Guidance on the use of long-acting insulin analogues for the treatment of diabetes insulin glargine. NICE Technology Appraisal Guidance No. 53. London: National Institute for Clinical Excellence. Available from: The Institute has also published a series of guidelines on the management of type 2 diabetes: (2002) Management of type 2 diabetes: retinopathy screening and early management. Inherited Clinical Guideline E. London:. Available from: (2002) Management of type 2 diabetes: renal disease prevention and early management. Inherited Clinical Guideline F. London:. Available from: (2002) Management of type 2 diabetes: management of blood glucose. Inherited Clinical Guideline G. London:. Available from: (2002) Management of type 2 diabetes: management of blood pressure and blood lipids. Inherited Clinical Guideline H. London:. Available from: Issue date: January 2003 Page 18 of 27

19 8.3 The following technology appraisals and clinical guidelines are part of the Institute s ongoing work programme: Technology Appraisal on patient models for diabetes education: due to be issued early 2003 Clinical Guideline on management of type 2 diabetes: foot care (update of an existing guideline published by the Royal College of General Practitioners): due to be issued late 2003 Clinical Guideline on type 1 diabetes: diagnosis and management of type 1 diabetes in primary and secondary care: due to be issued early Review of guidance 9.1 The review date for a technology appraisal refers to the month and year in which the Guidance Executive will consider any new evidence on the technology, in the form of an updated Assessment Report, and decide whether the technology should be referred to the Appraisal Committee for review. 9.2 The guidance on this technology will be reviewed in February Andrew Dillon Chief Executive January 2003 Issue date: January 2003 Page 19 of 27

20 Appendix A. Appraisal Committee members NOTE The Appraisal Committee is a standing advisory committee of the Institute. Its members are appointed for a 3-year term. A list of the Committee members who took part in the discussions for this appraisal appears below. The Appraisal Committee meets twice a month except in December, when there are no meetings. The Committee membership is split into two branches, with the chair, vice-chair and a number of other members attending meetings of both branches. Each branch considers its own list of technologies and ongoing topics are not moved between the branches. Committee members are asked to declare any interests in the technology to be appraised. If it is considered there is a conflict of interest, the member is excluded from participating further in that appraisal. The minutes of each Appraisal Committee meeting, which include the names of the members who attended and their declarations of interests, are posted on the NICE website. Professor R L Akehurst Dean, School of Health Related Research, Sheffield University Dr Tom Aslan General Practitioner, Stockwell, London Professor David Barnett (Chair) Professor of Clinical Pharmacology, University of Leicester Dr Sheila Bird MRC Biostatistics Unit, Cambridge Professor Rosamund Bryar Professor of Community & Primary Care Nursing, St Bartholomew s School of Nursing & Midwifery, London Issue date: January 2003 Page 20 of 27

21 Professor Martin Buxton Director of Health Economics Research Group, Brunel University, Uxbridge Dr Karl Claxton Health Economist, University of York Dr Richard Cookson Senior Lecturer, Health Economics, School of Health Policy and Practice, University of East Anglia, Norwich Professor Sarah Cowley Professor of Community Practice Development, Kings College, London Professor Terry Feest Clinical Director & Consultant Nephrologist, Richard Bright Renal Unit, & Chair of UK Renal Registry, Bristol Professor Gary A Ford Professor of Pharmacology of Old Age/Consultant Physician, Newcastle upon Tyne Hospitals NHS Trust Mrs Sue Gallagher Former Chief Executive, Merton, Sutton & Wandsworth Health Authority, London Ms Bethan George Interface Liaison Pharmacist, Tower Hamlets PCT and Royal London Hospital, Whitechapel Dr Trevor Gibbs Head, Global Clinical Safety & Pharmacovigilance, GlaxoSmithKline, Greenford Mr John Goulston Director of Finance, St Bartholoemew s Hospital & the London NHS Trust Professor Philip Home Professor of Diabetes Medicine, University of Newcastle upon Tyne Issue date: January 2003 Page 21 of 27

22 Dr Terry John General Practitioner, The Firs, London Mr Muntzer Mughal Consultant Surgeon, Lancashire Teaching Hospitals NHS Trust, Chorley Mr James Partridge Lay Representative, Chief Executive, Changing Faces, London Mrs Kathryn Roberts Nurse Practitioner, Hyde, Cheshire Professor Philip Routledge Professor of Clinical Pharmacology, College of Medicine, University of Wales, Cardiff Ms Anne Smith Consultant (Management) and Trustee of the Long Term Medical Conditions Alliance Professor Andrew Stevens (Vice-Chair) Professor of Public Health, University of Birmingham Dr Cathryn Thomas General Practitioner, & Senior Lecturer, Department of Primary Care & General Practice, University of Birmingham Dr Norman Vetter Reader, Department of Epidemiology, Statistics and Public Health, University of Wales College of Medicine, Cardiff Dr David Winfield Consultant Haematologist, Royal Hallamshire Hospital, Sheffield Issue date: January 2003 Page 22 of 27

23 Appendix B. Sources of evidence considered by the Committee A The assessment report for this appraisal was prepared by the Southampton Health Technology Assessment Centre, University of Southampton. Clinical and cost effectiveness of continuous subcutaneous insulin infusion for diabetes, August 2002 B The following organisations accepted the invitation to participate in this appraisal. They were invited to make submissions and comment on the draft scope and assessment report. They are also invited to comment on the ACD and consultee organisations are provided with the opportunity to appeal against the FAD. I Manufacturer/sponsors: Disetronic Medtronic Minimed II Professional/specialist and patient/carer groups: British Dietetic Association British Society for Paediatric Endocrinology and Diabetes and the Royal College for Paediatrics and Child Health Department of Health Diabetes UK Health Technology Board for Scotland Input Insulin Dependant Diabetes Trust Pump Management for Professionals (PUMP) Royal College of Nursing Royal College of Physicians, Association of Clinical Diabetologists, British Geriatrics Society and Diabetes UK Specialist Group Issue date: January 2003 Page 23 of 27

24 III Organisations (without the right of appeal): Health Technology Board for Scotland National Collaborating Centre for Chronic Conditions National Collaborating Centre for Women and Children s Health C The following individuals were selected from clinical expert and patient advocate nominations from the professional/specialist and patient/carer groups. They participated in the Appraisal Committee discussions and provided evidence to inform the Appraisal Committee s deliberations. They gave their expert personal view on insulin pump therapy by attending the initial Committee discussion and/or providing written evidence to the Committee. They were invited to comment on the ACD. Deborah Beskine, Patient Support Group Organiser, Input John Davis, National Coordinator, Input Joan Everett, Diabetes Nurse Specialist, Pump Management for Professionals (PUMP) Dr Peter Hammond, Consultant Physician, Harrogate District Hospital Dr Moira Harrison, on behalf of Diabetes UK Dr David Kerr, Consultant Physician, Royal Bournemouth Hospital Terry Northwood, on behalf of Diabetes UK Issue date: January 2003 Page 24 of 27

25 Appendix C. Detail on criteria for audit of the use of continuous subcutaneous insulin infusion for diabetes Possible objectives for an audit An audit on the use of CSII could be carried out to ensure that the treatment is offered as an option to people with type 1 diabetes for whom MDI therapy has failed and that patients are prepared for and supported to carry out CSII therapy. Possible patients to be included in the audit An audit could be carried out on all patients with type 1 diabetes for whom MDI therapy has failed, including children, adolescents, women who intend to become pregnant and pregnant women. For these purposes, people for whom MDI therapy has failed are defined as including (a) people who have tried MDI therapy, including, where appropriate, the use insulin glargine and (b) people in whom it has been impossible to maintain an HbA 1c level no greater than 7.5% (or 6.5% in the presence of microalbuminuria or adverse features of the metabolic syndrome) without disabling hypoglycaemia occurring, despite a high level of self care of their diabetes. For this purpose, disabling hypoglycaemia means the repeated and unpredictable occurrence of hypoglycaemia requiring third-party assistance that results in continuing anxiety over recurrence and is associated with significant adverse effect on quality of life. Measures that can be used as a basis for audit The measures that can be used in an audit on the use of CSII treatment are as follows. Criterion Standard Exceptions Definition of terms 1. The patient (with 100% of A. The patient See the definition on failure type 1 diabetes patients does not of MDI therapy given above that MDI therapy fails to control) is with type 1 diabetes for demonstrate the necessary Local specialist teams will Issue date: January 2003 Page 25 of 27

26 fails to control) is diabetes for the necessary have to decide what offered CSII whom MDI commitment constitutes demonstration of treatment therapy has (e.g. declines the necessary commitment failed as the treatment) and competence for audit defined and purposes above competence to use the CSII therapy effectively 2. CSII therapy is 100% of None Specialist team means a initiated only by a patients physician with a specialist trained specialist who receive interest in insulin pump team CSII therapy, a diabetes specialist nurse and a dietitian. Local teams will have to decide what constitutes training for members of the team 3. The patient is 100% of None If the patient is a child, provided with patients training should include the training in CSII who receive parents or carers therapy and ongoing support from a specialist team. CSII Local specialist teams will have to decide what constitutes the level of competence or minimum experience needed by the patient (or carer), the advice provided by the specialist team and the ongoing support, and how training and ongoing support will be Issue date: January 2003 Page 26 of 27

27 documented for audit purposes 4. The patient is 100% of None Local specialist teams will reviewed by his or patients have to decide what her specialist team who receive constitutes review, the CSII frequency of review and whether it is appropriate for the person to undergo a trial of switching to MDI incorporating insulin glargine, and how review will be documented for audit purposes Calculation of compliance with the measures Compliance with the measures described in the table is calculated as follows. Number of patients whose care is consistent with the criterion plus the number of patients who meet any exception Number of patients to whom the measure applies 100 Clinicians should review the findings of measurement, identify whether practice can be improved, agree on a plan to achieve any desired improvement, and repeat the measurement of actual practice to confirm that the desired improvement is being achieved. Issue date: January 2003 Page 27 of 27