Cummins, E. (Ewen), Royle, Pamela, Snaith, Ailsa, Greene, A., Robertson, L., McIntyre, Linda and Waugh, Norman. (2010) Clinical effectiveness and cost-effectiveness of continuous subcutaneous insulin infusion for diabetes : systematic review and economic evaluation. Health Technology Assessment, Vol.14 (No.11). pp. 1-208. ISSN 1366-5278

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Abstract

Based on the totality of evidence, using observational studies to supplement the limited data from randomised trials against best MDI, CSII provides some advantages over MDI in T1DM for both children and adults. However, there was no evidence that CSII is better than analogue-based MDI in T2DM or in pregnancy. Further trials with larger numbers and longer durations comparing CSII and optimised MDI in adults, adolescents and children are needed. In addition, there should be a trial of CSII versus MDI with similar provision of structured education in both arms. A trial is also needed for pregnant women with pre-existing diabetes, to investigate using CSII to the best effect.

Item Type:	Journal Article
Subjects:	R Medicine > RC Internal medicine
Divisions:	Faculty of Medicine > Warwick Medical School > Warwick Evidence Faculty of Medicine > Warwick Medical School > Health Sciences
Library of Congress Subject Headings (LCSH):	Diabetes -- Treatment, Insulin -- Therapeutic use
Journal or Publication Title:	Health Technology Assessment
Publisher:	NIHR Health Technology Assessment programme
ISSN:	1366-5278
Date:	February 2010
Volume:	Vol.14
Number:	No.11
Page Range:	pp. 1-208
Identification Number:	10.3310/hta14110
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access
Funder:	NIHR Health Technology Assessment Programme (Great Britain)
References:	1. Scottish Study Group for the Care of Diabetes in the Young. The incidence of childhood diabetes in Scotland. 2006. 41st Annual Meeting of the European Diabetes Epidemiology Group of the EASD, Krakow, Poland, 20–23 May, 2006. 2. Wilson, IV, Gale, EAM, Bingley, PJ. The rising incidence of childhood Type 1 diabetes in the Oxford region 1985–2004. Diabet Med 2007;24(Suppl. 1):1–29. 3. Yorkshire & Humber Public Health Observatory. PBS Diabetes Population Prevalence Model. Yorkshire & Humber Public Health Observatory; 2005. URL: www.yhpho.org.uk/viewResource. aspx?id=7 (accessed 26 December 2006). 4. Waugh N, Scotland G, McNamee P, Gillet M, Brennan A, Goyder E, et al. Screening for type 2 diabetes: literature review and economic modelling. Health Technol Assess 2007;11(17). 5. Yorkshire & Humber Public Health Observatory. Diabetes Key Facts. 2006 URL: www.yhpho.org. uk/diabetes_keyfacts.aspx (accessed 26 December 2006). 6. Turner R, Cull C, Holman R. United Kingdom prospective diabetes study 17: a 9-year update of a randomized, controlled trial on the effect of improved metabolic control over complications in non-insulin-dependent diabetes mellitus. Ann Intern Med 1996;124:136–45. 7. UK Prospective Diabetes Study. U.K. prospective diabetes study 16. Overview of 6 years’ therapy of type II diabetes: a progressive disease. U.K. Prospective Diabetes Study Group. [Erratum appears in Diabetes 1996;45:1655.] Diabetes 1995;44:1249–58. 8. Wright A, Burden ACF, Paisey RB, Cull CA, Holman RR. Sulfonylurea inadequacy: Efficacy of addition of insulin over 6 years in patients with type 2 diabetes in the U.K. Prospective Diabetes Study (UKPDS 57). Diabetes Care 2002;25:330–6. 9. Donnan PT, Steinke DT, Newton RW, Morris AD, Collaboration MEMO. Changes in treatment after the start of oral hypoglycaemic therapy in type 2 diabetes: a population-based study. Diabet Med 2002;19:606–10. 10. Siebenhofer A, Plank J, Berghold A, Jeitler K, Horvath K, Narath M, et al. Short acting insulin analogues versus regular human insulin in patients with diabetes mellitus. Cochrane Database Syst Rev 2006; Issue 2. 11. Colquitt J, Royle P, Waugh N. Are analogue insulins better than soluble in continuous subcutaneous insulin infusion? Results of a meta-analysis. Diabet Med 2003;20:863–6. 12. National Institute for Health and Clinical Excellence. Inhaled insulin for the treatment of type 1 and type 2 diabetes: Technology appraisal TA113. 25 January 2008. URL: www.nice.org.uk/Guidance/ TA113 (accessed 26 February 2009). 13. Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of longterm complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977–86. 14. Pickup JC, Keen H, Parsons JA, Alberti KG. Continuous subcutaneous insulin infusion: an approach to achieving normoglycaemia. Br Med J 1978;1:204–7. 15. Tamborlane WV, Sherwin RS, Genel M, Felig P. Reduction to normal of plasma glucose in juvenile diabetes by subcutaneous administration of insulin with a portable infusion pump. N Engl J Med 1979;300:573–8. 16. Lenhard MJ, Reeves GD. Continuous subcutaneous insulin infusion: a comprehensive review of insulin pump therapy. Arch Int Med 2001;161:2293–300. 17. Pickup J, Keen H. Continuous subcutaneous insulin infusion at 25 years: evidence base for the expanding use of insulin pump therapy in type 1 diabetes. Diabetes Care 2002;25:593–8. 18. Pickup J, Mattock M, Kerry S. Glycaemic control with continuous subcutaneous insulin infusion compared with intensive insulin injections in patients with type 1 diabetes: meta-analysis of randomised controlled trials. BMJ 2002;324:705. 19. Côté B, St-Hilaire C. Comparison of the insulin pump and multiple daily insulin injections in intensive therapy for type 1 diabetes. Montreal, PQ, Canada: Agence d’évaluation des technologies et des modes d’intervention en santé (AETMIS); 2005. 20. Graff MR, Rubin RR, Walker EA. How diabetes specialists treat their own diabetes: findings from a study of the AADE and ADA membership. Diabetes Educ 2000;26:460–7. 21. Pickup J, Keen H. Continuous subcutaneous insulin infusion in type 1 diabetes: is beneficial in selected patients and should be more widely available. BMJ 2001;322:1262–3. 22. Dunger DB, Sperling MA, Acerini CL, Bohn DJ, Daneman D, Danne TPA, et al. ESPE/LWPES consensus statement on diabetic ketoacidosis in children and adolescents. Arch Dis Child 2004;89:188–94. 23. Ganesh R, Suresh N, Ramesh J. Diabetic ketoacidosis in children. Nat Med J India 2006;19:155–8. 24. Henriksen OM, Roder ME, Prahl JB, Svendsen OL. Diabetic ketoacidosis in Denmark Incidence and mortality estimated from public health registries. Diabetes Res Clin Pract 2007;76:51–6. 25. Cryer PE. Hypoglycemia in diabetes: pathophysiological mechanisms and diurnal variation. Prog Brain Res 2006;153:361–5. 26. Ghafour IM, Allan D, Foulds WS. Common causes of blindness and visual handicap in the west of Scotland. Br J Ophthalmol 1983;67:209–13. 27. NHS Scotland. The Scottish Renal Registry Report 2002–2004. Edinburgh: ISD Scotland Publications; 2007. 28. Laing SP, Swerdlow AJ, Slater SD, Botha JL, Burden AC, Waugh NR, et al. The British Diabetic Association Cohort Study, II: Cause-specific mortality in patients with insulin-treated diabetes mellitus. Diabet Med 1999;16:466–71. 29. Laing SP, Swerdlow AJ, Slater SD, Burden AC, Morris A, Waugh NR, et al. Mortality from heart disease in a cohort of 23,000 patients with insulintreated diabetes. Diabetologia 2003;46:760–5. 30. Selvin E, Marinopoulos S, Berkenblit G, Rami T, Brancati FL, Powe NR, et al. Meta-analysis: glycosylated hemoglobin and cardiovascular disease in diabetes mellitus. Ann Intern Med 2004;141:421. 31. Stettler C, Allemann S, Juni P, Cull CA, Holman RR, Egger M, et al. Glycemic control and macrovascular disease in types 1 and 2 diabetes mellitus: Meta-analysis of randomized trials. Am Heart J 2006;152:27–38. 32. Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, Apelqvist J. The global burden of diabetic foot disease. Lancet 2005;366:1719–24. 33. Currie CJ, Morgan CL, Peters JR. The epidemiology and cost of inpatient care for peripheral vascular disease, infection, neuropathy, and ulceration in diabetes. Diabetes Care 1998;21:42–8. 34. Wang PH, Lau J, Chalmers TC. Meta-analysis of the effects of intensive glycemic control on late complications of type I diabetes mellitus. Online J Curr Clin Trials 1993;Doc No 60:5023. 35. Shamoon H, Duffy H, Fleischer N, Engel S, Saenger P, Strelyzn M, et al. The effect of intensive diabetes treatment on the progression of diabetic retinopathy in insulin-dependent diabetes mellitus: the diabetes control and complications trial. Arch Ophthalmol 1995;113:36–51. 36. Diabetes Control and Complications Trial Research Group. The absence of a glycemic threshold for the development of long-term complications: the perspective of the Diabetes Control and Complications Trial. Diabetes 1996;45:1289–98. 37. Genuth S, Lipps J, Lorenzi G, Nathan DM, Davis MD, Lachin JM, et al. Effect of intensive therapy on the microvascular complications of type 1 diabetes mellitus. JAMA 2002;287:2563–9. 38. Writing Team for the Diabetes Control and Complications Trial. Epidemiology of Diabetes Interventions and Complications Research Group. Sustained effect of intensive treatment of type 1 diabetes mellitus on development and progression of diabetic nephropathy: the Epidemiology of Diabetes Interventions and Complications (EDIC) study. JAMA 2003;290:2159–67. 39. Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, et al. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 2005;353:2643– 53. 40. Ihnat MA, Thorpe JE, Ceriello A. Hypothesis: The ‘metabolic memory’, the new challenge of diabetes. Diabet Med 2007;24:582–6. 41. Svoren BM, Volkening LK, Butler DA, Moreland EC, Anderson BJ, Laffel LM. Temporal trends in the treatment of pediatric type 1 diabetes and impact on acute outcomes. J Pediatr 2007;150:279– 85. 42. Scottish Study Group for the Care of the Young Diabetic. Factors influencing glycemic control in young people with type 1 diabetes in Scotland: a population-based study (DIABAUD2). Diabetes Care 2001;24:239–44. 43. Scottish Study Group for the Care of the Young with Diabetes. A longitudinal observational study of insulin therapy and glycaemic control in Scottish children with type 1 diabetes: DIABAUD 3. Diabet Med 2006;23:1216–21. 44. Diabetes UK. Diabetes: State of the Nations 2006. URL: www.diabetes.org.uk/Professionals/ Information_resources/Reports/Diabetes_State_of_ the_Nations_2006/(accessed 24 May 2007). 45. Hayward RA, Manning WG, Kaplan SH, Wagner EH, Greenfield S. Starting insulin therapy in patients with type 2 diabetes: effectiveness, complications, and resource utilization. [Erratum appears in JAMA 1999;281:1989.] JAMA 1997;278:1663–9. 46. Yki-Jarvinen H, Ryysy L, Kauppila M, Kujansuu E, Lahti J, Marjanen T, et al. Effect of obesity on the response to insulin therapy in non insulindependent diabetes mellitus. J Clin Endocrinol Metab 1997;82:4037–43. 47. Calvert MJ, McManus RJ, Freemantle N. Management of type 2 diabetes with multiple oral hypoglycaemic agents or insulin in primary care: retrospective cohort study. Br J Gen Pract 2007;57:455–60. 48. Gulliford MC, Ashworth M, Robotham D, Mohiddin A. Achievement of metabolic targets for diabetes by English primary care practices under a new system of incentives. Diabet Med 2007;24:505–11. 49. Diabetes Control and Complications Trial Research Group. Hypoglycemia in the diabetes control and complications trial. Diabetes 1997;46:271–86. 50. Colquitt JL, Green C, Sidhu MK, Hartwell D, Waugh N. Clinical and cost-effectiveness of continuous subcutaneous insulin infusion for diabetes. Health Technol Assess 2004;8(43). 51. National Institute for Health and Clinical Excellence. Guidance on the use of long-acting insulin analogues for the treatment of diabetes: insulin glargine. Technology Appraisal 53, 2002. http://guidance.nice.org.uk/TA53/guidance/pdf/ English (accessed 26 February 2009). 52. Hepburn DA, Frier BM. Hypoglycaemia and diabetes. In Lawson DH, Toft AD, editors. Current medicine. Edinburgh: Churchill Livingstone; 1994. 53. Nordfeldt S, Ludvigsson J. Fear and other disturbances of severe hypoglycaemia in children and adolescents with type 1 diabetes mellitus. J Pediatr Endocrinol Metab 2005;18:83–91. 54. Clarke WL, Gonder-Frederick A, Snyder AL, Cox DJ. Maternal fear of hypoglycemia in their children with insulin dependent diabetes mellitus. J Pediatr Endocrinol 1998;11(Suppl. 1):189–94. 55. Streisand R, Swift E, Wickmark T, Chen R, Holmes CS. Pediatric parenting stress among parents of children with type 1 diabetes: the role of selfefficacy, responsibility, and fear. J Pediatr Psychol 2005;30:513–21. 56. Heller S. How should hypoglycaemia unawareness be managed. In Gill G, Pickup J, Williams G, editors. Difficult diabetes. Oxford: Blackwell Science; 2001. 57. Warren RE, Frier BM. Hypoglycaemia and cognitive function. Diabetes Obes Metab 2005;7:493–503. 58. Jacobson AM, Musen G, Ryan CM, Silvers N, Cleary P, Waberski B, et al. Long-term effect of diabetes and its treatment on cognitive function. N Engl J Med 2007;356:1842–52. 59. Gold AE, Frier BM. Hypoglycemia: practical and clinical implications. In Kelnar CJH, editor. Childhood and adolescent diabetes. London: Chapman & Hall; 1995. 60. McCarthy AM, Lindgren S, Mengeling MA, Tsalikian E, Engvall J. Factors associated with academic achievement in children with type 1 diabetes. Diabetes Care 2003;26:112–17. 61. Northam EA, Anderson PJ, Jacobs R, Hughes M, Warne GL, Werther GA. Neuropsychological profiles of children with type 1 diabetes 6 years after disease onset. Diabetes Care 2001;24:1541–6. 62. Dahlquist G, Kallen B. School performance in children with type 1 diabetes: a population-based register study. Diabetologia 2007;50:957–64. 63. Desrocher M, Rovet J. Neurocognitive correlates of type 1 diabetes mellitus in childhood. Child Neuropsychol 2004;10:36–52. 64. Ferguson SC, Blane A, Wardlaw J, Frier BM, Perros P, McCrimmon RJ, et al. Influence of an early-onset age of type 1 diabetes on cerebral structure and cognitive function. Diabetes Care 2005;28:1431–7. 65. Hershey T, Perantie DC, Warren SL, Zimmerman EC, Sadler M, White NH. Frequency and timing of severe hypoglycemia affects spatial memory in children with type 1 diabetes. Diabetes Care 2005;28:2372–7. 66. Wysocki T, Harris MA, Mauras N, Fox L, Taylor A, Jackson SC, et al. Absence of adverse effects of severe hypoglycemia on cognitive function in school-aged children with diabetes over 18 months. Diabetes Care 2003;26:1100–5. 67. Leese GP, Wang J, Broomhall J, Kelly P, Marsden A, Morrison W, et al. Frequency of severe hypoglycemia requiring emergency treatment in type 1 and type 2 diabetes: a population-based study of health service resource use. Diabetes Care 2003;26:1176–80. 68. Donnelly LA, Morris AD, Frier BM, Ellis JD, Donnan PT, Durrant R, et al. Frequency and predictors of hypoglycaemia in type 1 and insulintreated type 2 diabetes: a population-based study. Diabet Med 2005;22:749–55. 69. Heller SR, Choudhary P, Davies C, Emery C, Campbell MJ, Freeman J, et al. Risk of hypoglycaemia in types 1 and 2 diabetes: Effects of treatment modalities and their duration. Diabetologia 2007;50:1140–7. 70. Bolli GB, Gerich JE. The ‘dawn phenomenon’: a common occurrence in both non-insulin-dependent and insulin-dependent diabetes mellitus. N Engl J Med 1984;310:746–50. 71. Pickup JC. Is insulin pump treatment justifiable? In Gill G, Pickup JC, Williams G, editors. Difficult diabetes. Oxford: Blackwell Science; 2001. 72. Kanc K, Janssen MM, Keulen ET, Jacobs MA, Popp- Snijders C, Snoek FJ, et al. Substitution of nighttime continuous subcutaneous insulin infusion therapy for bedtime NPH insulin in a multiple injection regimen improves counterregulatory hormonal responses and warning symptoms of hypoglycaemia in IDDM. Diabetologia 1998;41: 322–9. 73. DAFNE. Dose Adjustment For Normal Eating (DAFNE) website, 2009. URL: www.dafne.uk.com/ (accessed 26 February 2009). 74. National Institute for Clinical Excellence. Guidance on the use of continuous subcutaneous insulin infusion: Technology Appraisal No. 57, 2003. URL: www.nice.org.uk/guidance/TA57/ (accessed 26 February 2009). 75. Warren E, Weatherley-Jones E, Chilcott J, Beverley C. Systematic review and economic evaluation of a long-acting insulin analogue, insulin glargine. Health Technol Assess 2004;8(45). 76. Ashwell SG, Amiel SA, Bilous RW, Dashora U, Heller SR, Hepburn DA, et al. Improved glycaemic control with insulin glargine plus insulin lispro: a multicentre, randomized, cross-over trial in people with Type 1 diabetes. Diabet Med 2006;23:285–92. 77. Chatterjee S, Jarvis-Kay J, Rengarajan T, Lawrence IG, McNally PG, Davies MJ. Glargine versus NPH insulin: efficacy in comparison with insulin aspart in a basal bolus regimen in type 1 diabetes: the glargine and aspart study (GLASS) a randomised cross-over study. Diabetes Res Clin Pract 2007;77:215–22. 78. De L, I, Vague P, Selam JL, Skeie S, Lang H, Draeger E, et al. Insulin detemir used in basal-bolus therapy in people with type 1 diabetes is associated with a lower risk of nocturnal hypoglycaemia and less weight gain over 12 months in comparison to NPH insulin. Diabetes Obes Metab 2005;7:73–82. 79. Dixon B, Peter CH, Burdick J, Fiallo-Scharer R, Walravens P, Klingensmith G, et al. Use of insulin glargine in children under age 6 with type 1 diabetes. Pediatric Diabetes 2005;6:150–4. 80. Fulcher GR, Gilbert RE, Yue DK. Glargine is superior to neutral protamine Hagedorn for improving glycated haemoglobin and fasting blood glucose levels during intensive insulin therapy. Intern Med J 2005;35:536–42. 81. Hermansen K, Fontaine P, Kukolja KK, Peterkova V, Leth G, Gall MA. Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal-bolus therapy for patients with type 1 diabetes. Diabetologia 2004;47:622–9. 82. Hershon KS, Blevins TC, Blevins TC, Blevins TC. Once-daily insulin glargine compared with twicedaily NPH insulin in patients with type 1 diabetes. Endocr Pract 2004;10:10–17. 83. Home P, Bartley P, Russell-Jones D, Hanaire-Broutin H, Heeg JE, Abrams P, et al. Insulin detemir offers improved glycemic control compared with NPH insulin in people with type 1 diabetes: a randomized clinical trial. Diabetes Care 2004;27:1081–7. 84. Home PD, Rosskamp R, Forjanic-Klapproth J, Dressler A, European Insulin Glargine Study Group. A randomized multicentre trial of insulin glargine compared with NPH insulin in people with type 1 diabetes. Diabetes Metab Res Rev 2005;21:545–53. 85. Kudva YC, Basu A, Jenkins GD, Pons GM, Quandt LL, Gebel JA, et al. Randomized controlled clinical trial of glargine versus ultralente insulin in the treatment of type 1 diabetes. Diabetes Care 2005;28:10–14. 86. Murphy NP, Keane SM, Ong KK, Ford-Adams M, Edge JA, Acerini CL, et al. Randomized cross-over trial of insulin glargine plus lispro or NPH insulin plus regular human insulin in adolescents with type 1 diabetes on intensive insulin regimens. Diabetes Care 2003;26:799–804. 87. Pieber TR, Draeger E, Kristensen A, Grill V. Comparison of three multiple injection regimens for type 1 diabetes: morning plus dinner or bedtime administration of insulin detemir vs. morning plus bedtime NPH insulin. Diabet Med 2005;22:850–7. 88. Porcellati F, Rossetti P, Pampanelli S, Fanelli CG, Torlone E, Scionti L, et al. Better long-term glycaemic control with the basal insulin glargine as compared with NPH in patients with type 1 diabetes mellitus given meal-time lispro insulin. Diabet Med 2004;21:1213–20. 89. Russell-Jones D, Simpson R, Hylleberg B, Draeger E, Bolinder J. Effects of QD insulin detemir or neutral protamine Hagedorn on blood glucose control in patients with type I diabetes mellitus using a basal-bolus regimen. Clin Ther 2004;26: 724–36. 90. Schober E, Schoenle E, Van Dyk J, Wernicke-Panten K, Pediatric Study Group of Insulin Glargine. Comparative trial between insulin glargine and NPH insulin in children and adolescents with type 1 diabetes mellitus. J Pediatr Endocrinol 2002;15: 369–76. 91. Standl E, Lang H, Roberts A. The 12-month efficacy and safety of insulin detemir and NPH insulin in basal-bolus therapy for the treatment of type 1 diabetes. Diabetes Technol Ther 2004;6:579–88. 92. Vague P, Selam JL, Skeie S, De L, I, Elte JW, Haahr H, et al. Insulin detemir is associated with more predictable glycemic control and reduced risk of hypoglycemia than NPH insulin in patients with type 1 diabetes on a basal-bolus regimen with premeal insulin aspart. Diabetes Care 2003;26:590–6. 93. Mathieu C. Can we reduce hypoglycaemia with insulin detemir? International Journal of Obesity & Related Metabolic Disorders 2004;28:S35–40. 94. Peterson GE. Intermediate and long-acting insulins: a review of NPH insulin, insulin glargine and insulin detemir. Curr Med Res Opin 2006;22:2613– 19. 95. Bangstad HJ, Danne T, Deeb LC, Jarosz-Chobot P, Urakami T, Hanas R. Insulin treatment. Pediatr Diabetes 2007;8:88–102. 96. Palmer AJ, Roze S, Valentine WJ, Smith I, Wittrup- Jensen KU. Cost-effectiveness of detemir-based basal/bolus therapy versus NPH-based basal/bolus therapy for type 1 diabetes in a UK setting: an economic analysis based on meta-analysis results of four clinical trials. Curr Med Res Opin 2004;20:1729– 46. 97. Valentine WJ, Palmer AJ, Erny-Albrecht KM, Ray JA, Cobden D, Foos V, et al. Cost-effectiveness of basal insulin from a US health system perspective: comparative analyses of detemir, glargine, and NPH. Adv Ther 2006;23:191–207. 98. Horvath K, Jeitler K, Berghold A, Ebrahim SH, Gratzer TW, Plank J, et al. Long-acting insulin analogues versus NPH insulin (human isophane insulin) for type 2 diabetes mellitus. Cochrane Database Syst Rev 2007. 99. Boland EA, Grey M, Oesterle A, Fredrickson L, Tamborlane WV. Continuous subcutaneous insulin infusion. A new way to lower risk of severe hypoglycemia, improve metabolic control, and enhance coping in adolescents with type 1 diabetes. Diabetes Care 1999;22:1779–84. 100. Mack-Fogg J, Bates S, Faro B, Sciera M, Ippolito K, Orlowski CC, et al. Safe and effective use of continuous subcutaneous insulin infusion in young children with type 1 diabetes mellitus. Pediatr Res 2002;51:122A. 101. Rudolph JW, Hirsch IB. Assessment of therapy with continuous subcutaneous insulin infusion in an academic diabetes clinic. Endocr Pract 2002;8:401–5. 102. Haardt MJ, Berne C, Dorange C, Slama G, Selam J-L. Efficacy and indications of CSII revisited: The Hotel-Dieu cohort. Diabet Med 1997;14:407–8. 103. Bending JJ, Pickup JC, Keen H. Frequency of diabetic ketoacidosis and hypoglycemic coma during treatment with continuous subcutaneous insulin infusion. Audit of medical care. Am J Med 1985;79:685–91. 104. Chantelau E, Spraul M, Muhlhauser I, Gause R, Berger M. Long-term safety, efficacy and sideeffects of continuous subcutaneous insulin infusion treatment for type 1 (insulin-dependent) diabetes mellitus: a one centre experience. Diabetologia 1989;32:421–6. 105. Raskin P. Treatment of type-I diabetes with portable insulin infusion devices. Diabetes Care 1982;5:48–52. 106. Department of Health. Insulin pump services: Report of the Insulin Pumps Working Group, 2007. URL: www.dh.gov.uk/en/Publicationsandstatistics/ Publications/PublicationsPolicyAndGuidance/ DH_072777 (accessed 26 February 2009). 107. Pickup JC, Sutton AJ. Severe hypoglycaemia and glycaemic control in type 1 diabetes: meta-analysis of multiple daily insulin injections compared with continuous subcutaneous insulin infusion. Diabet Med 2008;25:765–74. 108. Barnard KD, Lloyd CE, Skinner TC. Systematic literature review: quality of life associated with insulin pump use in type 1 diabetes. Diabet Med 2007;24:607–17. 109. Khan KS, ter Riet G, Glanville J, Sowden A, Kleijnen J. Undertaking systematic reviews of research on effectiveness: CRD’s guidance for those carrying out and commissioning reviews. CRD Report 4 (2nd edn); 2001. 110. Doyle EA, Weinzimer SA, Steffen AT, Ahern JA, Vincent M, Tamborlane WV. A randomized, prospective trial comparing the efficacy of continuous subcutaneous insulin infusion with multiple daily injections using insulin glargine. Diabetes Care 2004;27:1554–8. 111. Thomas RM, Aldibbiat A, Griffin W, Cox MA, Leech NJ, Shaw JA. A randomized pilot study in type 1 diabetes complicated by severe hypoglycaemia, comparing rigorous hypoglycaemia avoidance with insulin analogue therapy, CSII or education alone. Diabet Med 2007;24:778–83. 112. Maran A, Crazzolara D, Nicoletti M, Costa S, dal Pos M, Tiengo A, et al. A randomized crossover study to compare continuous subcutaneous insulin infusion (CSII) with multiple daily injection (MDI) in type 1 diabetic patients previously treated with CSII. Diabetologia 2005;48:A328. 113. Bolli GB, Capani F, Home PD, Kerr D, Thomas R, Torlone E, et al. Comparison of a multiple daily injection regimen with once-daily insulin glargine basal insulin and mealtime lispro, to continuous subcutaneous insulin infusion: a randomised, open, parallel study. Diabetes 2004;53:A107–8. 114. Berthe E, Lireux B, Coffin C, Goulet-Salmon B, Houlbert D, Boutreux S, et al. Effectiveness of intensive insulin therapy by multiple daily injections and continuous subcutaneous infusion: a comparison study in type 2 diabetes with conventional insulin regimen failure. Horm Metab Res 2007;39:224–9. 115. Herman WH, Ilag LL, Johnson SL, Martin CL, Sinding J, Al Harthi A, et al. A clinical trial of continuous subcutaneous insulin infusion versus multiple daily injections in older adults with type 2 diabetes. Diabetes Care 2005;28:1568–73. 116. Raskin P, Bode BW, Marks JB, Hirsch IB, Weinstein RL, McGill JB, et al. Continuous subcutaneous insulin infusion and multiple daily injection therapy are equally effective in type 2 diabetes: a randomized, parallel-group, 24-week study. Diabetes Care 2003;26:2598–603. 117. Wainstein J, Metzger M, Boaz M, Minuchin O, Cohen Y, Yaffe A, et al. Insulin pump therapy vs. multiple daily injections in obese type 2 diabetic patients. Diabet Med 2005;22:1037–46. 118. Cohen D, Weintrob N, Benzaquen H, Galatzer A, Fayman G, Phillip M. Continuous subcutaneous insulin infusion versus multiple daily injections in adolescents with type I diabetes mellitus: a randomized open crossover trial. J Pediatr Endocrinol 2003;16:1047–50. 119. DeVries JH, Snoek FJ, Kostense PJ, Masurel N, Heine RJ, Dutch Insulin Pump Study Group. A randomized trial of continuous subcutaneous insulin infusion and intensive injection therapy in type 1 diabetes for patients with long-standing poor glycemic control. Diabetes Care 2002;25:2074–80. 120. Dimeglio LA, Pottorff TM, Boyd SR, France L, Fineberg N, Eugster EA. A randomized, controlled study of insulin pump therapy in diabetic preschoolers. J Pediatr 2004;145:380–4. 121. Fox LA, Buckloh LM, Smith SD, Wysocki T, Mauras N. A randomized controlled trial of insulin pump therapy in young children with type 1 diabetes. Diabetes Care 2005;28:1277–81. 122. Hoogma RP, Hoekstra JB, Michels BP, Levi M. Comparison between multiple daily insulin injection therapy (MDI) and continuous subcutaneous insulin infusion therapy (CSII), results of the five nations study. Diabetes Res Clin Pract 2006;74(Suppl. 2):S144–7. 123. Pozzilli P, Crino A, Schiaffini R, Manfrini S, Fioriti E, Coppolino G, et al. A 2-year pilot trial of continuous subcutaneous insulin infusion versus intensive insulin therapy in patients with newly diagnosed type 1 diabetes (IMDIAB 8). Diabetes Technol Ther 2003;5:965–74. 124. Weintrob N, Schechter A, Benzaquen H, Shalitin S, Lilos P, Galatzer A, et al. Glycemic patterns detected by continuous subcutaneous glucose sensing in children and adolescents with type 1 diabetes mellitus treated by multiple daily injections vs continuous subcutaneous insulin infusion. Arch Pediatr Adolesc Med 2004;158:677–84. 125. Weintrob N, Schechter A, Bezaquen H, Shalitin S, Lilos P, Galatzer A, et al. Glycemic patterns detected by continuous subcutaneous glucose sensing in children with type 1 diabetes treated by MDI or CSII. Diabetes 2003;52:A100. 126. Wilson DM, Buckingham BA, Kunselman EL, Sullivan MM, Paguntalan HU, Gitelman SE. A two-center randomized controlled feasibility trial of insulin pump therapy in young children with diabetes. Diabetes Care 2005;28:15–19. 127. Department of Health. National service framework for diabetes: standards. London: Department of Health; 2001. 128. Scottish Intercollegiate Guidelines Network. Management of diabetes. SIGN Publication No. 55. Edinburgh: Scottish Intercollegiate Guidelines Network; 2001. 129. Casson IF, Clarke CA, Howard CV, McKendrick O, Pennycook S, Pharoah PO, et al. Outcomes of pregnancy in insulin dependent diabetic women: results of a five year population cohort study. BMJ 1997;315:275–8. 130. Hawthorne G, Robson S, Ryall EA, Sen D, Roberts SH, Ward Platt MP. Prospective population based survey of outcome of pregnancy in diabetic women: results of the Northern Diabetic Pregnancy Audit, 1994. BMJ 1997;315:279–81. 131. Confidential Enquiry into Maternal and Child Health (CEMACH). Diabetes in Pregnancy: Are we providing the best care? Findings of a National Enquiry, February 2007. URL: www.cemach.org.uk/Final%20 CEMACH%20report%20070207.pdf. 132. Lapolla A, Dalfra MG, Masin M, Bruttomesso D, Piva I, Crepaldi C, et al. Analysis of outcome of pregnancy in type 1 diabetics treated with insulin pump or conventional insulin therapy. Acta Diabetologica 2003;40:143–9. 133. Gimenez M, Conget I, Nicolau J, Pericot A, Levy I. Outcome of pregnancy in women with type 1 diabetes intensively treated with continuous subcutaneous insulin infusion or conventional therapy. A case-control study. Acta Diabetologica 2007;44:34–7. 134. Chen R, Yogev Y, Weissman-Brenner A, Haroush AB, Hod M. Level of glycemic control and pregnancy outcome in type-1 diabetes: A comparison between multiple daily injections (MDI) and continuous subcutaneous insulin infusions (CSII). Am J Obstet Gynecol 2006;195:S132. 135. Cheng Y, Block-Kurbisch I, Inturrisi M, Ustinov A, Caughey A. Insulin pump compared to injected insulin in pregnant women with type 1 diabetes. Am J Obstet Gynecol 2006;195:S125. 136. Kinsley BT, Al-Agha R, Murray S, Firth R. Continuous subcutaneous insulin infusion (CSII) versus multiple daily injection regimes using soluble human insulin or rapid acting insulin analoque in T1DM in pregnancy (T1DMP). Diabetologia 2005;48:A314–15. 137. Jimenez M, Hernaez R, Conget I, Alonso A, Yago G, Pericot A, et al. Metabolic control, maternal and perinatal outcomes in type 1 diabetic pregnancies intensively treated with conventional insulin therapy vs. continuous subcutaneous insulin infusion. Diabetologia 2005;48:A315. 138. Pickup JC, Kidd J, Burmiston S, Yemane N. Effectiveness of continuous subcutaneous insulin infusion in hypoglycaemia-prone type 1 diabetes. Pract Diabetes Int 2005;22:10–14. 139. Pickup JC, Kidd J, Burmiston S, Yemane N. Determinants of glycaemic control in type 1 diabetes during intensified therapy with multiple daily insulin injections or continuous subcutaneous insulin infusion: importance of blood glucose variability. Diabetes/Metab Res Rev 2006;22:232–7. 140. Rodrigues IA, Reid HA, Ismail K, Amiel SA. Indications and efficacy of continuous subcutaneous insulin infusion (CSII) therapy in Type 1 diabetes mellitus: a clinical audit in a specialist service. Diabet Med 2005;22:842–9. 141. Bruttomesso D, Costa S, Crazzolara D, Di Bartolo P, Girelli A, Tiengo A, et al. Continuous subcutaneous insulin infusion (CSII) in Italy. Diabetes Res Clin Pract 2006;74(Suppl. 2):S130–4. 142. Norgaard K. A nationwide study of continuous subcutaneous insulin infusion (CSII) in Denmark. Diabet Med 2003;20:307–11. 143. Radermecker RP, Legrand DA, Scheen AJ. Continuous subcutaneous insulin therapy in type 1 diabetic patients: retrospective study of about 500 patient-years. Diabetologia 2005;48:A328. 144. D’Annunzio G, Minuto N, Serfaino M, Minicucci L, Pistorio A, Lorini R. Continuous subcutaneous insulin infusion (CSII) in young patients with type 1 diabetes mellitus (T1DM): A follow-up study. Diabetes 2005;54:A665. 145. Linkeschova R, Raoul M, Bott U, Berger M, Spraul M. Less severe hypoglycaemia, better metabolic control, and improved quality of life in Type 1 diabetes mellitus with continuous subcutaneous insulin infusion (CSII) therapy; an observational study of 100 consecutive patients followed for a mean of 2 years. Diabet Med 2002;19:746–51. 146. Reda E, Von Reitzenstein A, Dunn P. Metabolic control with insulin pump therapy: the Waikato experience. New Zealand Med J 2007;120:U2401. 147. Nimri R, Weintrob N, Benzaquen H, Ofan R, Fayman G, Phillip M. Insulin pump therapy in youth with type 1 diabetes: a retrospective paired study. Pediatrics 2006;117:2126–31. 148. Jankovec Z, Lacigova S, Zourek M, Krcma M, Rusavy Z. Long-term results of continuous subcutaneous insulin infusion (CSII) treatment in the Czech Republic. Diabetes 2005;54:A494. 149. Alemzadeh R, Ellis JN, Holzum MK, Parton EA, Wyatt DT. Beneficial effects of continuous subcutaneous insulin infusion and flexible multiple daily insulin regimen using insulin glargine in type 1 diabetes. Pediatrics 2004;114:e91–5. 150. Hanas R, Adolfsson P. Insulin pumps in pediatric routine care improve long-term metabolic control without increasing the risk of hypoglycemia. Pediatr Diabetes 2006;7:25–31. 151. Kordonouri O, Hartmann R, Lauterborn R, Barnekow C, Hoeffe J, Deiss D. Age-specific advantages of continuous subcutaneous insulin infusion as compared with multiple daily injections in pediatric patients: one-year follow-up comparison by matched-pair analysis. Diabetes Care 2006;29:133–4. 152. McMahon SK, Airey FL, Marangou DA, McElwee KJ, Carne CL, Clarey AJ, et al. Insulin pump therapy in children and adolescents: improvements in key parameters of diabetes management including quality of life. Diabet Med 2005;22:92–6. 153. Saha M-T, Huupponen T, Knip M, Juuti M, Komulainen J. Continuous subcutaneous insulin infusion in the treatment of children and adolescents with type 1 diabetes mellitus. J Pediatr Endocrinol Metab 2002;15:1005–10. 154. Willi SM, Planton J, Egede L, Schwarz S. Benefits of continuous subcutaneous insulin infusion in children with type 1 diabetes. J Pediatr 2003;143:796–801. 155. Wood JR, Moreland EC, Volkening LK, Svoren BM, Butler DA, Laffel LM. Durability of insulin pump use in pediatric patients with type 1 diabetes. Diabetes Care 2006;29:2355–60. 156. Weinzimer SA, Ahern JH, Doyle EA, Vincent MR, Dziura J, Steffen AT, et al. Persistence of benefits of continuous subcutaneous insulin infusion in very young children with type 1 diabetes: a follow-up report. [Erratum appears in Pediatrics 2005;115:518.] Pediatrics 2004;114:1601–5. 157. Conrad SC, McGrath MT, Gitelman SE. Transition from multiple daily injections to continuous subcutaneous insulin infusion in type 1 diabetes mellitus. J Pediatr 2002;140:235–40. 158. Plotnick LP, Clark LM, Brancati FL, Erlinger T. Safety and effectiveness of insulin pump therapy in children and adolescents with type 1 diabetes. Diabetes Care 2003;26:1142–6. 159. Raile K, Noelle V, Landgraf R, Schwarz HP. Weight in adolescents with type 1 diabetes mellitus during continuous subcutaneous insulin infusion (CSII) therapy. J Pediatr Endocrinol 2002;15:607–12. 160. Sulli N, Shashaj B. Continuous subcutaneous insulin infusion in children and adolescents with diabetes mellitus: decreased HbA1c with low risk of hypoglycemia. J Pediatr Endocrinol 2003;16:393–9. 161. Fahlen M, Eliasson B, Oden A. Optimization of basal insulin delivery in type 1 diabetes: a retrospective study on the use of continuous subcutaneous insulin infusion and insulin glargine. Diabet Med 2005;22:382–6. 162. Lepore G, Dodesini AR, Nosari I, Trevisan R. Effect of continuous subcutaneous insulin infusion vs multiple daily insulin injection with glargine as basal insulin: an open parallel long-term study. Diabetes Nutr Metab Clin Exp 2004;17:84–9. 163. Siegel-Czarkowski L, Herold KC, Goland RS. Continuous subcutaneous insulin infusion in older patients with type 1 diabetes. Diabetes Care 2004;27:3022–3. 164. Litton J, Rice A, Friedman N, Oden J, Lee MM, Freemark M. Insulin pump therapy in toddlers and preschool children with type 1 diabetes mellitus. J Pediatr 2002;141:490–5. 165. Berhe T, Postellon D, Wilson B, Stone R. Feasibility and safety of insulin pump therapy in children aged 2 to 7 years with type 1 diabetes: a retrospective study. Pediatrics 2006;117:2132–7. 166. Ahern JA, Boland EA, Doane R, Ahern JJ, Rose P, Vincent M, et al. Insulin pump therapy in pediatrics: a therapeutic alternative to safely lower HbA1c levels across all age groups. Pediatric Diabetes 2002;3:10–15. 167. Garcia-Garcia E, Galera R, Aguilera P, Cara G, Bonillo A. Long-term use of continuous subcutaneous insulin infusion compared with multiple daily injections of glargine in pediatric patients. J Pediatr Endocrinol 2007;20:37–40. 168. Schiaffini R, Ciampalini P, Spera S, Cappa M, Crino A. An observational study comparing continuous subcutaneous insulin infusion (CSII) and insulin glargine in children with type 1 diabetes. Diabetes Metab Res Rev 2005;21:347–52. 169. Cersosimo E, Jornsay D, Arce C, Rieff M, Feldman E, Defronzo R. Improved clinical outcomes with intensive insulin pump therapy in type 1 diabetes. Diabetes 2002;51:A128. 170. Hunger-Dathe W, Braun A, Muller UA, Schiel R, Femerling M, Risse A. Insulin pump therapy in patients with type 1 diabetes mellitus: results of the Nationwide Quality Circle in Germany (ASD) 1999– 2000. Exp Clin Endocrinol Diabetes 2003;111:428–34. 171. Juliusson PB, Graue M, Wentzel-Larsen T, Sovik O. The impact of continuous subcutaneous insulin infusion on health-related quality of life in children and adolescents with type 1 diabetes. Acta Paediatrica 2006;95:1481–7. 172. Liberatore JR, Perlman K, Buccino J, Artiles-Sisk A, Daneman D. Continuous subcutaneous insulin infusion pump treatment in children with type 1 diabetes mellitus. J Pediatr Endocrinol Metab 2004;17:223–6. 173. Mack-Fogg JE, Orlowski CC, Jospe N. Continuous subcutaneous insulin infusion in toddlers and children with type 1 diabetes mellitus is safe and effective. Pediatr Diabetes 2005;6:17–21. 174. Shehadeh N, Battelino T, Galatzer A, Naveh T, Hadash A, de Vries L, et al. Insulin pump therapy for 1–6 year old children with type 1 diabetes. Isr Med Assoc J (IMAJ) 2004;6:284–6. 175. Garg SK, Walker AJ, Hoff HK, D’Souza AO, Gottlieb PA, Chase HP. Glycemic parameters with multiple daily injections using insulin glargine versus insulin pump. Diabetes Technol Ther 2004;6:9–15. 176. Ronsin O, Jannot-Lamotte MF, Vague P, Lassman- Vague V. Factors related to CSII compliance. Diabetes Metab 2005;31:90–5. 177. Sucunza A, Ubeda J, Martinez C, Martinez MJ, Abraldes N, Corcoy R, et al. Unsuccessful outcome of insulin pump treatment is not predictable by clinical characteristics. Diabetes 2005;54:A105. 178. Mednick L, Cogen FR, Streisand R. Satisfaction and quality of life in children with type 1 diabetes and their parents following transition to insulin pump therapy. Child Health Care 2004;33:169–83. 179. Simmons JH, McFann KK, Brown AC, Rewers A, Cruz E, Klingensmith GJ. Achieving pediatric ADA HbA1c goals: insulin pump therapy vs injection therapy. Diabetes 2006;55:A413. 180. Sullivan-Bolyai S, Knafl K, Tamborlane W, Grey M. Parents’ reflections on managing their children’s diabetes with insulin pumps. J Nurs Scholarsh 2004;36:316–23. 181. Toni S, Reali MF, Fasulo A, Festini P, Medici A, Martinucci ME. The use of insulin pumps improves the metabolic control in children and adolescents with type 1 diabetes. [Erratum appears in Arch Dis Child 2004;89:985 – Note: ‘Festini, F’ corrected to ‘Festini, P’]. Arch Dis Child 2004;89:796–7. 182. Ugrasbul F, Popovic J. BMI changes in pediatric patients with type diabetes mellitus (T1DM) treated with continuous subcutaneous insulin infusion (CSII) therapy. Diabetes 2006;55:A414. 183. Wallach EJ, Iazzetti L, Bowlby DA, Greig F, Patel A, Hyman S, et al. Sustained improvement in hemoglobin A1C during long-term treatment with continuous subcutaneous insulin infusion (CSII) in pediatric patients. Diabetes 2005;54:A666. 184. Alemzadeh R, Palma-Sisto P, Parton E, Holzum M, Kichler J. Insulin pump therapy attenuated glycemic instability without improving glycemic control in a one-year study of preschool children with type 1 diabetes. Diabetes 2006;55:A97. 185. Hanas R, Lindblad B, Lindgren F. Predisposing conditions and insulin pump use in a 2-year population study of pediatric ketoacidosis in Sweden. Diabetes 2005;54:A455. 186. Conwell LS, Pope E, Artiles AM, Mohanta A, Daneman A, Daneman D. Dermatological Complications of Continuous Subcutaneous Insulin Infusion in Children and Adolescents. J Pediatr 2008;152:622–8. 187. Kaufman FR, Halvorson M, Kim C, Pitukcheewanont P. Use of insulin pump therapy at nighttime only for children 7–10 years of age with type 1 diabetes. Diabetes Care 2000;23:579–82. 188. Retnakaran R, Hochman J, DeVries JH, Hanaire- Broutin H, Heine RJ, Melki V, et al. Baseline A1c determines efficacy of insulin pump therapy: A pooled analysis of studies of continuous subcutaneous insulin infusion vs multiple daily injection regimens using rapid-acting insulin analogues. Diabetes 2004;53:A114. 189. Hirsch IB, Bode BW, Garg S, Lane WS, Sussman A, Hu P, et al. Continuous subcutaneous insulin infusion (CSII) of insulin aspart versus multiple daily injection of insulin aspart/insulin glargine in type 1 diabetic patients previously treated with CSII. Diabetes Care 2005;28:533–8. 190. Barnard KD, Skinner TC. Qualitative study into quality of life issues surrounding insulin pump use in type 1 diabetes. Pract Diabetes Int 2007;24:143–8. 191. Barnard KD, Skinner TC. Cross-sectional study into quality of life issues surrounding insulin pump use in type 1 diabetes. Pract Diabetes Int 2008;25:194– 200. 192. World Health Organization. WHO Quality of Life- BREF (WHOQOL-BREF), 2004. URL: www.who. int/substance_abuse/research_tools/whoqolbref/en/ (accessed 26 February 2009). 193. Weissberg-Benchell J, Antisdel-Lomaglio J, Seshadri R. Insulin pump therapy: a meta-analysis. Diabetes Care 2003;26:1079–87. 194. Siebenhofer A, Plank J, Berghold A, Horvath K, Sawicki PT, Beck P, et al. Meta-analysis of shortacting insulin analogues in adult patients with type 1 diabetes: continuous subcutaneous insulin infusion versus injection therapy. Diabetologia 2004;47:1905. 195. Kapellen TM, Heidtmann B, Bachmann J, Ziegler R, Grabert M, Holl RW. Indications for insulin pump therapy in different age groups-an analysis of 1567 children and adolescents. Diabet Med 2007;24:836–42. 196. Laing SP, Swerdlow AJ, Slater SD, Botha JL, Burden AC, Waugh NR, et al. The British Diabetic Association Cohort Study, I: all-cause mortality in patients with insulin-treated diabetes mellitus. Diabet Med 1999;16:459–65. 197. Edge JA, Ford-Adams ME, Dunger DB. Causes of death in children with insulin dependent diabetes 1990–96. Arch Dis Child 1999;81:318–23. 198. Thordarson H, Sovik O. Dead in bed syndrome in young diabetic patients in Norway. Diabet Med 1995;12:782–7. 199. Tunbridge WM. Factors contributing to deaths of diabetics under fifty years of age. On behalf of the Medical Services Study Group and British Diabetic Association. Lancet 1981;2:569–72. 200. Scuffham P, Carr L. The cost-effectiveness of continuous subcutaneous insulin infusion compared with multiple daily injections for the management of diabetes. Diabet Med 2003;20:586–93. 201. Roze S, Valentine WJ, Zakrzewska KE, Palmer AJ. Health-economic comparison of continuous subcutaneous insulin infusion with multiple daily injection for the treatment of Type 1 diabetes in the UK. Diabet Med 2005;22:1239–45. 202. Conget D, I, Serrano CD, Rodriguez Barrios JM, Levy M, I, Castell AC, Roze S. [Cost-utility analysis of insulin pumps compared to multiple daily doses of insulin in patients with type 1 diabetes mellitus in Spain]. [Spanish] Revista Espanola de Salud Publica 2006;80:679–95. 203. Palmer AJ, Roze S, Valentine WJ, Minshall ME, Foos V, Lurati FM, et al. The CORE Diabetes Model: Projecting long-term clinical outcomes, costs and cost-effectiveness of interventions in diabetes mellitus (types 1 and 2) to support clinical and reimbursement decision-making. Curr Med Res Opin 2004;20(Suppl.1):S5–26. 204. Palmer AJ, Roze S, Valentine WJ, Minshall ME, Foos V, Lurati FM, et al. Validation of the CORE Diabetes Model against epidemiological and clinical studies. Curr Med Res Opin 2004;20(Suppl.1):S27–40. 205. Krolewski AS, Warram JH, Christlieb AR, Busick EJ, Kahn CR. The changing natural history of nephropathy in type I diabetes. Am J Med 1985;78:785–94. 206. National Diabetes Data Group of the National Institute of Diabetes and Digestive and Kidney Diseases. Diabetes in America. 2nd edn. 1995. http:// diabetes.niddk.nih.gov/dm/pubs/america/ (accessed 26 February 2009). 207. National Institute of Diabetes & Digestive & Kidney Diseases. Epidemiology of Diabetes Interventions and Complications Study (EDIC), 2008. URL: www.niddk.nih.gov/patient/edic/edic-public.htm (accessed 26 February 2009). 208. Mount Hood 4 Modeling Group. Computer modeling of diabetes and its complications: a report on the Fourth Mount Hood Challenge Meeting. Diabetes Care 2007;30:1638–46. 209. Diabetes Control and Complications Trial Research Group. Effect of intensive diabetes treatment on the development and progression of longterm complications in adolescents with insulindependent diabetes mellitus: Diabetes Control and Complications Trial. Diabetes Control and Complications Trial Research Group. J Pediatr 1994;125:177–88. 210. Cryer PE, Davis SN, Shamoon H. Hypoglycemia in diabetes. Diabetes Care 2003;26:1902–12. 211. National Institute for Health and Clinical Excellence. Diabetes (type 1 and 2) – inhaled insulin: Technology Appraisal 113, 2006. http:// guidance.nice.org.uk/TA113 (accessed 26 February 2009). 212. Clarke P, Gray A, Legood R, Briggs A, Holman R. The impact of diabetes-related complications on healthcare costs: results from the United Kingdom Prospective Diabetes Study (UKPDS Study No. 65). Diabet Med 2003;20:442–50. 213. Clarke P, Gray A, Holman R. Estimating utility values for health states of type 2 diabetic patients using the EQ-5D (UKPDS 62). Med Decis Making 2002;22:340–9. 214. Coffey JT, Brandle M, Zhou H, Marriott D, Burke R, Tabaei BP, et al. Valuing health-related quality of life in diabetes. Diabetes Care 2002;25:2238–43. 215. Tengs TO, Wallace A. One thousand health-related quality-of-life estimates. Med Care 2000;38:583–637. 216. Australian Institute of Health and Welfare. The burden of disease and injury in Australia 2003. URL: www.aihw.gov.au/publications/hwe/bodaiia03/ bodaiia03.pdf (accessed 6 August 2007). 217. Brown MM, Brown GC, Sharma S. Value-based medicine and vitreoretinal diseases. Curr Opin Ophthalmol 2004;15:167–72. 218. Carrington AL, Mawdsley SK, Morley M, Kincey J, Boulton AJ. Psychological status of diabetic people with or without lower limb disability. Diabetes Res Clin Pract 1996;32:19–25. 219. Davis RE, Morrissey M, Peters JR, Wittrup-Jensen K, Kennedy-Martin T, Currie CJ. Impact of hypoglycaemia on quality of life and productivity in type 1 and type 2 diabetes. Curr Med Res Opin 2005;21:1477–83. 220. Lundkvist J, Berne C, Bolinder B, Jonsson L. The economic and quality of life impact of hypoglycemia. Eur J Health Econ 2005;6:197–202. 221. Tabaei BP, Shill-Novak J, Brandle M, Burke R, Kaplan RM, Herman WH. Glycemia and the quality of well-being in patients with diabetes. Qual Life Res 2004;13:1153–61. 222. Wikblad K, Leksell J, Wibell L. Health-related quality of life in relation to metabolic control and late complications in patients with insulin dependent diabetes mellitus. Qual Life Res 1996;5:123–30. 223. Speight J, Shaw JAM. Does one size really fit all? Only by considering individual preferences and priorities will the true impact of insulin pump therapy on quality of life be determined. Diabet Med 2007;24:693–5. 224. Tsui E, Barnie A, Ross S, Parkes R, Zinman B. Intensive insulin therapy with insulin lispro: a randomized trial of continuous subcutaneous insulin infusion versus multiple daily insulin injection. Diabetes Care 2001;24:1722–7. 225. Weintrob N, Benzaquen H, Galatzer A, Shalitin S, Lazar L, Fayman G, et al. Comparison of continuous subcutaneous insulin infusion and multiple daily injection regimens in children with type 1 diabetes: a randomized open crossover trial. Pediatrics 2003;112:559–64. 226. Hoogma RP, Hammond PJ, Gomis R, Kerr D, Bruttomesso D, Bouter KP, et al. Comparison of the effects of continuous subcutaneous insulin infusion (CSII) and NPH-based multiple daily insulin injections (MDI) on glycaemic control and quality of life: results of the 5-nations trial. Diabet Med 2006;23:141–7. 227. Hoogma RP, Spijker AJ, Doorn-Scheele M, van Doorn TT, Michels RP, van Doorn RG, et al. Quality of life and metabolic control in patients with diabetes mellitus type 1 treated by continuous subcutaneous insulin infusion or multiple daily insulin injections. Neth J Med 2004;62:383–7. 228. Garmo A, Pettersson-Frank B, Ehrenberg A. Treatment effects and satisfaction in diabetic patients changing from multiple daily insulin injections to CSII. Pract Diabetes Int 2004;21:7–12. 229. Sanfield JA, Hegstad M, Hanna RS. Protocol for outpatient screening and initiation of continuous subcutaneous insulin infusion therapy: impact on cost and quality. Diabetes Educ 2002;28:599–607. 230. Bruttomesso D, Pianta A, Crazzolara D, Scaldaferri E, Lora L, Guarneri G, et al. Continuous subcutaneous insulin infusion (CSII) in the Veneto region: efficacy, acceptability and quality of life. Diabet Med 2002;19:628–34. 231. Barnard KD, Skinner C. Qualitative study into quality of life benefits associated with insulin pump use. Diabetes 2006;55:A612. 232. Reid SM, Lawson ML. Comparison of continuous subcutaneous insulin infusion versus conventional treatment of Type 1 diabetes with respect to metabolic control, quality of life and treatment satisfaction. Pediatric Res 2002;51:A122–3. 233. Galatzer A, Weintrob N, Cohen D, Benzaquen H, Rimer A, Ofan R, et al. Treatment satisfaction of type 1 diabetic patients: continuous subcutaneous insulin infusion versus multiple daily injection. Diabetes 2002;51:A619. 234. Schweitzer MA, Pieber T, Heinemann L, Grunder S, Buhr A. Treatment satisfaction and metabolic control in type 2 patients using CSII: results from an international observational study. Diabetologia 2006;49:592. 235. Castell C, Palmer AJ, Rodriguez JM, Roze S, Serrano-Contreras D, Zakrzewska K. Assessing the efficiency of using Continuous Subcutaneous Insulin-Infusion (CSII) versus multiple daily injections (MDI) in Spanish diabetes mellitus type- 1 (DM1) patients. Cost-effectiveness analysis. Value Health 2005;8:A161. 236. Zakrzewska K, Roze S, Valentine WJ, Palmer AJ. Health economic comparison of continuous subcutaneous insulin infusion with multiple daily injection for the treatment of type 1 diabetes in the UK. Value Health 2004;7:649–50. 237. Zakrzewska K, Valentine W, Roze S, Palmer A, Spinas G. Continuous subcutaneous insulin infusion reduces incidence of diabetes-related complications when compared with multiple daily injections for type 1 diabetes treatment: a health economic analysis in Switzerland. Diabetes 2005;54:A610. 238. Roze S, Palmer AJ, Foos V, Lurati FM. Costeffectiveness of continuous subcutaneous insulin infusion versus multiple daily injections for intensive control of Type 1 diabetes: a French analysis. Diabetologia 2002;45:A302. 239. Goodall G, Nicklasson L, Zakrzewska K, Foos V, Valentine WJ, Roze S, et al. Continuous subcutaneous insulin infusion versus multiple daily injection of insulin in patients with type 1 diabetes: a long-term health economic analysis in the Norwegian and Swedish settings. Value Health 2006;9:A227. 240. Nicklasson L, Zakrzewska K, Roze S, Voss V, Attvall S, Palmer A, et al. Continuous subcutaneous insulin infusion versus multiple daily injections for type 1 diabetes: a cost-effectiveness analysis for Sweden. Diabetologia 2006;49:541. 241. Roze S, Palmer AEJ. Long-term cost-effectiveness of the use of insulin pump compared to multiple daily injections in type 1 diabetic adolescents. Diabetes 2002;51:A281. 242. Feltbower RG, Campbell FM, Bodansky HJ, Stephenson CR, McKinney PA. Insulin pump therapy in childhood diabetes-cost implications for Primary Care Trusts. Diabet Med 2006;23:86–9. 243. Nuboer R, Bruining GJ. Cost-effectiveness of continuous subcutaneous insulin infusion (CSII) in children: illusion or delusion? Pediatr Diabetes 2006;7(Suppl. 4):39–44. 244. Mbowe OT, Buysschaert M, Hermans MP. Institutional costs of continuous subcutaneous insulin infusion in type 1 diabetes: an assessment using Activity-Based Costing (ABC) method. Diabetes 2004;53:A294. 245. Ulahannan T, Myinit NN, Lonnen KF. Making the case for insulin pump therapy. Pract Diabetes Int 2007;24:252–6. 246. Curtis L, Netten A. Personal Social Services Research Unit: Unit Costs of Health and Social Care, 2006. URL: www.pssru.ac.uk/pdf/uc/uc2006/ uc2006.pdf. 247. Ghatnekar O, Persson U, Willis M, Odegaard K. Cost effectiveness of Becaplermin in the treatment of diabetic foot ulcers in four European countries. Pharmacoeconomics 2001;19:767–78. 248. UKPDS 40. Cost effectiveness analysis of improved blood pressure control in hypertensive patients with type 2 diabetes: UKPDS 40. UK Prospective Diabetes Study Group. BMJ 1998;317:720–6. 249. Meads C, Salas C, Roberts T, Moore D, Fry-Smith A, Hyde C. Clinical effectiveness and cost-utility of photodynamic therapy for wet age-related macular degeneration: a systematic review and economic evaluation. Health Technol Assess 2003;7(9). 250. INPUT. INsulin PUmp Therapy: raising awareness of insulin pump therapy in the UK. 2008 URL: www.input.me.uk/ (accessed 26 February 2009). 251. INPUT. Review of NICE Technology Appraisal No. 57 Insulin Pump Therapy Joint submission from INPUT and Insulin Pumpers, 8 December 2007. URL: www.nice.org.uk/guidance/index. jsp?action=download&o=38246 (accessed 26 February 2009). 252. Barnard KD, Speight J, Skinner TC. Quality of life and impact of continuous subcutaneous insulin infusion for children and their parents. Pract Diabetes Int 2008;25:278–84. 253. Children with DIABETES. Children with DIABETES online community, 2006. URL: www. childrenwithdiabetes.com (accessed 26 February 2009). 254. Department of Health. National Service Framework for Children, Young People and Maternity Services: Medicines for Children and Young People. London: Department of Health; 2004. 255. NHS Scotland. Scottish Diabetes Framework. Edinburgh: Scottish Executive; 2002. 256. Khoo E, Miller D, Gazis A. Development and audit of a CSII service. Diabet Med 2007;24:76. 257. Zisser, H. The impact of insulin pump infusion set disconnects on short-term glycemic control. American Diabetes Association, 67th Scientific Sessions, Chicago, IL, 22–23 June 2007. 258. Pickup J. Personal statement on Continuous Subcutaneous Insulin Infusion, 2008. URL: www.nice.org.uk/nicemedia/pdf/ JohnPickupStatement240907CF.pdf (accessed 25 February 2009). 259. Diabetes UK. Postcode lottery on insulin pumps. 2007 URL: www.diabetes.org.uk/en/Get_involved/ Campaigning/Ongoing-campaigns/Postcode-lotteryon- insulin-pumps/(accessed 26 February 2009). 260. Pickup JC. Are insulin pumps underutilized in type 1 diabetes? Yes. Diabetes Care 2006;29:1449–52. 261. Canadian Agency for Drugs and Technologies in Health. CEDAC Final Recommendation and Reconsideration and Reasons for Recommendation: insulin glargine resubmission, Sanofi-Aventis Canada, 2006. URL: www.cadth.ca/media/cdr/ complete/cdr_complete_Lantus_Oct25–06.pdf (accessed 6 August 2007). 262. Farrar D, Tuffnell D, West J. Continuous subcutaneous insulin infusion versus multiple daily injections of insulin for pregnant women with diabetes. Cochrane Database Syst Rev 2007; Issue 2. 263. Roche Diagnostics Ltd. Additional response: clinical and cost-effectiveness of continuous subcutaneous infusion for diabetes: updating review, 19 November 2007. URL: www.nice.org.uk/guidance/ index.jsp?action=download&o=38238 (accessed 26 February 2009). 264. Peyrot M, Rubin RR. Patient-Reported Outcomes (PRO) for an Integrated Real-Time Continuous Glucose Monitoring/Insulin Pump (RT-CGM/CSII) System. Abstract no. 0461-P. American Diabetes Association, 67th Scientific Sessions, Chicago, IL, 22–23 June 2007. 265. Hirsch IB, Bode BW, Abelseth J, Fischer JS, Kaufman FR, Mastrototaro J, et al. Patient-Reported Outcomes (PRO) for an Integrated Real-Time Continuous Glucose Monitoring/Insulin Pump (RT-CGM/CSII) System. Abstract no. 0090-OR. American Diabetes Association, 67th Scientific Sessions, Chicago, IL, 22–23 June 2007. 266. NHS Quality Improvement Scotland. Continuous glucose monitors in diabetes mellitus – the Continuous Glucose Monitoring System (CGMS): Evidence Note 8, 2005. URL: www.nhshealthquality. org/nhsqis/files/evidence_note8.pdf (accessed 6 August 2007). 267. Hovorka R. Continuous glucose monitoring and closed-loop systems. Diabet Med 2006;23:1–12. 268. Logtenberg SJJ, Van Ballegooie E, Israel-Bultman H, van Linde A, Bilo HJG. Glycaemic control, health status and treatment satisfaction in subjects with diabetes mellitus treated with continuous intraperitoneal insulin infusion (CIPII). A single centre experience. Diabetologia 2006;49:592–3. 269. Renard E, Schaepelynck-Belicar P. Implantable insulin pumps. A position statement about their clinical use. Diabetes Metab 2007;33:158–66. 270. Bismuth E, Svoren B, Volkening LK, Butler DA, Laffel LM. Impact of Insulin Pump Therapy and Blood [beta]-OHB Ketone Monitoring on Glycemic Outcomes in Youth with Type 1 Diabetes (T1D). Abstract no. 1920-P. American Diabetes Association, 67th Scientific Sessions, Chicago, IL, 22–23 June 2007. 271. Brinchmann-Hansen O, Dahl-Jorgensen K, Hanssen KF, Sandvik L. The response of diabetic retinopathy to 41 months of multiple insulin injections, insulin pumps, and conventional insulin therapy. Arch Ophthalmol 1988;106:1242–6. 272. Chiasson JL, Ducros F, Poliquin HM, Lopez D, Lecavalier L, Hamet P. Continuous subcutaneous insulin infusion (Mill-Hill Infuser) versus multiple injections (Medi-Jector) in the treatment of insulindependent diabetes mellitus and the effect of metabolic control on microangiopathy. Diabetes Care 1984;7:331–7. 273. Hanaire-Broutin H, Melki V, Bessieres-Lacombe S, Tauber JP. Comparison of continuous subcutaneous insulin infusion and multiple daily injection regimens using insulin lispro in type 1 diabetic patients on intensified treatment: a randomized study. The Study Group for the Development of Pump Therapy in Diabetes. Diabetes Care 2000;23:1232–5. 274. Home PD, Capaldo B, Burrin JM, Worth R, Alberti KG. A crossover comparison of continuous subcutaneous insulin infusion (CSII) against multiple insulin injections in insulin-dependent diabetic subjects: improved control with CSII. Diabetes Care 1982;5:466–71. 275. Nathan DM, Lou PAJ. Intensive conventional and insulin pump therapy in adult type 1 diabetes. A crossover study. Ann Intern Med 1982;97:31–6. 276. Saurbrey N, Arnold-Larsen S, Moller-Jensen B, Kuhl C. Comparison of continuous subcutaneous insulin infusion with multiple insulin injections using the NovoPen. Diabet Med 1988;5:150–3. 277. Schiffrin A, Belmonte MM. Comparison between continuous subcutaneous insulin infusion and multiple injection of insulin. A one-year prospective study. Diabetes 1982;31:255–64. 278. Tsui E, Barnie A, Ross S, Parkes R, Zinman B. Intensive insulin therapy with insulin lispro: a randomized trial of continuous subcutaneous insulin infusion versus multiple daily insulin injection. Diabetes Care 2001;24:1722–7. 279. Haakens K, Hanssen KF, Dahl-Jorgensen K, Vaaler S, Aagenaes O, Mosand R. Continuous subcutaneous insulin infusion (CSII), multiple injections (MI) and conventional insulin therapy (CT) in self-selecting insulin-dependent diabetic patients. A comparison of metabolic control, acute complications and patient preferences. J Intern Med 1990;228:457–64. 280. Schmitz A, Christiansen JS, Christensen CK, Hermansen K, Mogensen CE. Effect of pump versus pen treatment on glycaemic control and kidney function in long-term uncomplicated insulindependent diabetes mellitus (IDDM). Dan Med Bull 1989;36:176–8. 281. Ziegler D, Dannehl K, Koschinsky T, Toeller M, Gries FA. Comparison of continuous subcutaneous insulin infusion and intensified conventional therapy in the treatment of type I diabetes: a two year randomized study. Diabetes Nutr Metab Clin Exp 1990;3:203–13. 282. Bode BW, Steed RD, Davidson PC. Reduction in severe hypoglycemia with long-term continuous subcutaneous insulin infusion in type I diabetes. Diabetes Care 1996;19:324–7. 283. Nosadini R, Velussi M, Fioretto P, Doria A, Avogaro A, Trevisan R, et al. Frequency of hypoglycaemic and hyperglycaemic–ketotic episodes during conventional and subcutaneous continuous insulin infusion therapy in IDDM. Diabetes Nutr Metab 1988;1:289–96. 284. Melki V, Renard E, Lassmann-Vague V, Boivin S, Guerci B, Hanaire-Broutin H, et al. Improvement of HbA1c and blood glucose stability in IDDM patients treated with lispro insulin analog in external pumps. Diabetes Care 1998;21:977–82. 285. Raskin P, Holcombe JH, Tamborlane WV, Malone JI, Strowig S, Ahern JA, et al. A comparison of insulin lispro and buffered regular human insulin administered via continuous subcutaneous insulin infusion pump. J Diabetes Complications 2001;15:295– 300. 286. Renner R, Pfutzner A, Trautmann M, Harzer O, Sauter K, Landgraf R. Use of insulin lispro in continuous subcutaneous insulin infusion treatment. Results of a multicenter trial. German Humalog- CSII Study Group. Diabetes Care 1999;22:784–8. 287. Schmauss S, Konig A, Landgraf R. Human insulin analogue [LYS(B28), PRO(B29)]: the ideal pump insulin? Diabet Med 1998;15:247–9. 288. Zinman B, Tildesley H, Chiasson JL, Tsui E, Strack T. Insulin lispro in CSII: results of a doubleblind crossover study. Diabetes 1997;46:440–3. 289. Bode B, Weinstein R, Bell D, McGill J, Nadeau D, Raskin P, et al. Comparison of insulin aspart with buffered regular insulin and insulin lispro in continuous subcutaneous insulin infusion: a randomized study in type 1 diabetes. Diabetes Care 2002;25:439–44. 290. Britten N, Jones R, Murphy E, Stacy R. Qualitative research methods in general practice and primary care. Fam Pract 1995;12:104–14. 291. Pope C, Mays N. Reaching the parts other methods cannot reach: an introduction to qualitative methods in health and health services research. BMJ 1995;311:42–5. 292. Mason J. Qualitative researching. London: Thousand Oaks; 2002. 293. Creswel JW. Qualitative inquiry and research design: choosing among five approaches. London: Sage Publications; 2003. 294. van der Heijden K. Scenarios: the art of strategic conversation. Chichester: John Wiley; 2005. 295. Glaser NS, Strauss A. Discovery of grounded theory. Chicago, IL: Aldine; 1967. 296. Strauss A, Corbin J. Basics of qualitative research: grounded theory procedures and techniques. London: Sage; 1990. 297. Mechanic D. Public trust and initiatives for new health care partnerships. Milbank Q 1998;76:281– 302. 298. Brownlie J, Greene A, Howson A (editors). Researching trust and health. New York, NY: Routledge; 2008.
URI:	http://wrap.warwick.ac.uk/id/eprint/44120

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