{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T00:57:11Z","timestamp":1792025831495,"version":"4.4.0"},"reference-count":158,"publisher":"National Institute for Health and Care Research","issue":"42","license":[{"start":{"date-parts":[[2018,8,1]],"date-time":"2018-08-01T00:00:00Z","timestamp":1533081600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["08\/14\/39"],"award-info":[{"award-number":["08\/14\/39"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]},{"name":"F. Hoffman-La Roche AG (Basel, Switzerland)"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"\n Background<\/jats:title>\n The risk of developing long-term complications of type 1 diabetes (T1D) is related to glycaemic control and is reduced by the use of intensive insulin treatment regimens: multiple daily injections (MDI) (\u2265\u20094) and continuous subcutaneous insulin infusion (CSII). Despite a lack of evidence that the more expensive treatment with CSII is superior to MDI, both treatments are used widely within the NHS.<\/jats:p>\n <\/jats:sec>\n \n Objectives<\/jats:title>\n (1) To compare glycaemic control during treatment with CSII and MDI and (2) to determine safety and cost-effectiveness of the treatment, and quality of life (QoL) of the patients.<\/jats:p>\n <\/jats:sec>\n \n Design<\/jats:title>\n A pragmatic, open-label randomised controlled trial with an internal pilot and 12-month follow-up with 1\u2009:\u20091 web-based block randomisation stratified by age and centre.<\/jats:p>\n <\/jats:sec>\n \n Setting<\/jats:title>\n Fifteen diabetes clinics in hospitals in England and Wales.<\/jats:p>\n <\/jats:sec>\n \n Participants<\/jats:title>\n Patients aged 7 months to 15 years.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Continuous subsutaneous insulin infusion or MDI initiated within 14 days of diagnosis of T1D.<\/jats:p>\n <\/jats:sec>\n \n Data sources<\/jats:title>\n Data were collected at baseline and at 3, 6, 9 and 12 months using paper forms and were entered centrally. Data from glucometers and CSII were downloaded. The Health Utilities Index Mark 2 was completed at each visit and the Pediatric Quality of Life Inventory (PedsQL, diabetes module) was completed at 6 and 12 months. Costs were estimated from hospital patient administration system data.<\/jats:p>\n <\/jats:sec>\n \n Outcomes<\/jats:title>\n The primary outcome was glycosylated haemoglobin (HbA1c<\/jats:sub>) concentration at 12 months. The secondary outcomes were (1) HbA1c<\/jats:sub> concentrations of <\u200948\u2009mmol\/mol, (2) severe hypoglycaemia, (3) diabetic ketoacidosis (DKA), (4) T1D- or treatment-related adverse events (AEs), (5) change in body mass index and height standard deviation score, (6) insulin requirements, (7) QoL and (8) partial remission rate. The economic outcome was the incremental cost per quality-adjusted life-year (QALY) gained.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n A total of 293 participants, with a median age of 9.8 years (minimum 0.7 years, maximum 16 years), were randomised (CSII, n<\/jats:italic>\u2009=\u2009149; MDI, n<\/jats:italic>\u2009=\u2009144) between May 2011 and January 2015. Primary outcome data were available for 97% of participants (CSII, n<\/jats:italic>\u2009=\u2009143; MDI, n<\/jats:italic>\u2009=\u2009142). At 12 months, age-adjusted least mean squares HbA1c<\/jats:sub> concentrations were comparable between groups: CSII, 60.9\u2009mmol\/mol [95% confidence interval (CI) 58.5 to 63.3\u2009mmol\/mol]; MDI, 58.5\u2009mmol\/mol (95% CI 56.1 to 60.9\u2009mmol\/mol); and the difference of CSII\u2009\u2013\u2009MDI, 2.4\u2009mmol\/mol (95% CI \u20130.4 to 5.3\u2009mmol\/mol). For HbA1c<\/jats:sub> concentrations of <\u200948\u2009mmol\/mol (CSII, 22\/143 participants; MDI, 29\/142 participants), the relative risk was 0.75 (95% CI 0.46 to 1.25), and for partial remission rates (CSII, 21\/86 participants; MDI, 21\/64), the relative risk was 0.74 (95% CI 0.45 to 1.24). The incidences of severe hypoglycaemia (CSII, 6\/144; MDI, 2\/149 participants) and DKA (CSII, 2\/144 participants; MDI, 0\/149 participants) were low. In total, 68 AEs (14 serious) were reported during CSII treatment and 25 AEs (eight serious) were reported during MDI treatment. Growth outcomes did not differ. The reported insulin use was higher with CSII (mean difference 0.1\u2009unit\/kg\/day, 95% CI 0.0 to 0.2\u2009unit\/kg\/day; p<\/jats:italic>\u2009=\u20090.01). QoL was slightly higher for those randomised to CSII. From a NHS perspective, CSII was more expensive than MDI mean total cost (\u00a31863, 95% CI \u00a31620 to \u00a32137) with no additional QALY gains (\u20130.006 QALYs, 95% CI \u20130.031 to 0.018 QALYs).<\/jats:p>\n <\/jats:sec>\n \n Limitations<\/jats:title>\n Generalisability beyond 12 months is uncertain.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n No clinical benefit of CSII over MDI was identified. CSII is not a cost-effective treatment in patients representative of the study population.<\/jats:p>\n <\/jats:sec>\n \n Future work<\/jats:title>\n Longer-term follow-up is required to determine if clinical outcomes diverge after 1 year. A qualitative exploration of patient and professional experiences of MDI and CSII should be considered.<\/jats:p>\n <\/jats:sec>\n \n Trial registration<\/jats:title>\n Current Controlled Trials ISRCTN29255275 and EudraCT 2010-023792-25.<\/jats:p>\n <\/jats:sec>\n \n Funding<\/jats:title>\n This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment<\/jats:italic>; Vol. 22, No. 42. See the NIHR Journals Library website for further project information. The cost of insulin pumps and consumables supplied by F. Hoffman-La Roche AG (Basel, Switzerland) for the purpose of the study were subject to a 25% discount on standard NHS costs.<\/jats:p>\n <\/jats:sec>","DOI":"10.3310\/hta22420","type":"journal-article","created":{"date-parts":[[2018,8,15]],"date-time":"2018-08-15T09:19:24Z","timestamp":1534324764000},"page":"1-112","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":33,"title":["Continuous subcutaneous insulin infusion versus multiple daily injections in children and young people at diagnosis of type 1 diabetes: the SCIPI RCT"],"prefix":"10.3310","volume":"22","clinical-trial-number":[{"clinical-trial-number":"isrctn29255275","registry":"10.18810\/isrctn","type":"results"},{"clinical-trial-number":"2010-023792-25","registry":"10.18810\/euctr","type":"results"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3128-5574","authenticated-orcid":true,"given":"Joanne","family":"Blair","sequence":"first","affiliation":[{"name":"Department of Endocrinology, Alder Hey Children\u2019s NHS Foundation Trust, Liverpool, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1312-8911","authenticated-orcid":true,"given":"Andrew","family":"McKay","sequence":"additional","affiliation":[{"name":"Clinical Trials Research Centre, University of Liverpool, Liverpool, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4346-1221","authenticated-orcid":true,"given":"Colin","family":"Ridyard","sequence":"additional","affiliation":[{"name":"Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0455-4660","authenticated-orcid":true,"given":"Keith","family":"Thornborough","sequence":"additional","affiliation":[{"name":"Department of Diabetes, Alder Hey Children\u2019s NHS Foundation Trust, Liverpool, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5209-1854","authenticated-orcid":true,"given":"Emma","family":"Bedson","sequence":"additional","affiliation":[{"name":"Clinical Trials Research Centre, University of Liverpool, Liverpool, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1909-3211","authenticated-orcid":true,"given":"Matthew","family":"Peak","sequence":"additional","affiliation":[{"name":"Department of Research, Alder Hey Children\u2019s NHS Foundation Trust, Liverpool, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3729-3276","authenticated-orcid":true,"given":"Mohammed","family":"Didi","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Alder Hey Children\u2019s NHS Foundation Trust, Liverpool, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8494-7258","authenticated-orcid":true,"given":"Francesca","family":"Annan","sequence":"additional","affiliation":[{"name":"Paediatric and Adolescent Division, University College Hospital, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5189-3812","authenticated-orcid":true,"given":"John W","family":"Gregory","sequence":"additional","affiliation":[{"name":"Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8247-7459","authenticated-orcid":true,"given":"Dyfrig","family":"Hughes","sequence":"additional","affiliation":[{"name":"Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3021-1955","authenticated-orcid":true,"given":"Carrol","family":"Gamble","sequence":"additional","affiliation":[{"name":"Clinical Trials Research Centre, University of Liverpool, Liverpool, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"6221","published-online":{"date-parts":[[2018,8]]},"reference":[{"key":"key20180814084752091_ref1-bib1","volume-title":"National Paediatric Diabetes Audit 2015\u201316 Report 1: Care Processes and Outcomes","author":"Royal College of Paediatrics and Child Health"},{"key":"key20180814084752091_ref1-bib2","doi-asserted-by":"publisher","first-page":"2027","DOI":"10.1016\/S0140-6736(09)60568-7","article-title":"Incidence trends for childhood type 1 diabetes in Europe during 1989\u20132003 and predicted new cases 2005\u201320: a multicentre prospective registration study","volume":"373","author":"Patterson","year":"2009","journal-title":"Lancet"},{"key":"key20180814084752091_ref1-bib3","doi-asserted-by":"publisher","first-page":"977","DOI":"10.1056\/NEJM199309303291401","article-title":"The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus","volume":"329","author":"Diabetes Control Complications Trial Research Group","year":"1993","journal-title":"N Engl J Med"},{"key":"key20180814084752091_ref1-bib4","volume-title":"Continuous Subcutaneous Insulin Infusion for the Treatment of Diabetes Mellitus","author":"NICE","year":"2008"},{"key":"key20180814084752091_ref1-bib5","doi-asserted-by":"publisher","first-page":"79","DOI":"10.1046\/j.1464-5491.1999.00024.x","article-title":"Metabolic control and prevalence of microvascular complications in young Danish patients with type 1 diabetes mellitus","volume":"16","author":"Olsen","year":"1999","journal-title":"Diabet Med"},{"key":"key20180814084752091_ref1-bib6","doi-asserted-by":"publisher","first-page":"2368","DOI":"10.2337\/dc11-0102","article-title":"Continued reduction in the prevalence of retinopathy in adolescents with type 1 diabetes: role of insulin therapy and glycemic control","volume":"34","author":"Downie","year":"2011","journal-title":"Diabetes Care"},{"key":"key20180814084752091_ref1-bib7","doi-asserted-by":"publisher","first-page":"372","DOI":"10.1111\/pedi.12100","article-title":"HbA1c tracking and bio-psychosocial determinants of glycaemic control in children and adolescents with type 1 diabetes: retrospective cohort study and multilevel analysis","volume":"15","author":"Lawes","year":"2014","journal-title":"Pediatr Diabetes"},{"key":"key20180814084752091_ref1-bib8","doi-asserted-by":"publisher","first-page":"16","DOI":"10.1002\/pdi.1734","article-title":"Early glycaemic control is predictive of long-term control: a retrospective observational study","volume":"30","author":"Jackson","year":"2013","journal-title":"Pract Diabetes"},{"key":"key20180814084752091_ref1-bib9","doi-asserted-by":"publisher","first-page":"229","DOI":"10.1111\/pedi.12085","article-title":"A high mean-HbA1c value 3\u201315 months after diagnosis of type 1 diabetes in childhood is related to metabolic control, macroalbuminuria, and retinopathy in early adulthood \u2013 a pilot study using two nation-wide population based quality registries","volume":"15","author":"Samuelsson","year":"2014","journal-title":"Pediatr Diabetes"},{"key":"key20180814084752091_ref1-bib10","doi-asserted-by":"publisher","first-page":"367","DOI":"10.1111\/pedi.12279","article-title":"Arterial stiffness in adolescents and young adults with and without type 1 diabetes: the SEARCH CVD study","volume":"16","author":"Shah","year":"2015","journal-title":"Pediatr Diabetes"},{"key":"key20180814084752091_ref1-bib11","doi-asserted-by":"publisher","first-page":"e005644","DOI":"10.1136\/bmjopen-2014-005644","article-title":"Evidence for a persistent, major excess in all cause admissions to hospital in children with type-1 diabetes: results from a large Welsh national matched community cohort study","volume":"5","author":"Sayers","year":"2015","journal-title":"BMJ Open"},{"key":"key20180814084752091_ref1-bib12","doi-asserted-by":"publisher","first-page":"541","DOI":"10.1111\/pedi.12088","article-title":"Glycemic extremes in youth with T1DM: the structural and functional integrity of the developing brain","volume":"14","author":"Arbelaez","year":"2013","journal-title":"Pediatr Diabetes"},{"key":"key20180814084752091_ref1-bib13","doi-asserted-by":"publisher","first-page":"499","DOI":"10.1111\/1753-0407.12193","article-title":"Type 1 diabetes-associated cognitive decline: a meta-analysis and update of the current literature","volume":"6","author":"Tonoli","year":"2014","journal-title":"J Diabetes"},{"key":"key20180814084752091_ref1-bib14","doi-asserted-by":"publisher","first-page":"303","DOI":"10.1111\/pedi.12090","article-title":"The contribution of glycemic control to impaired growth during puberty in young people with type 1 diabetes and microalbuminuria","volume":"15","author":"Marcovecchio","year":"2014","journal-title":"Pediatr Diabetes"},{"key":"key20180814084752091_ref1-bib15","doi-asserted-by":"publisher","first-page":"58","DOI":"10.1111\/pedi.12130","article-title":"Depression, metabolic control, and antidepressant medication in young patients with type 1 diabetes","volume":"16","author":"Plener","year":"2015","journal-title":"Pediatr Diabetes"},{"key":"key20180814084752091_ref1-bib16","doi-asserted-by":"publisher","first-page":"593","DOI":"10.1186\/1756-0500-7-593","article-title":"Prevalence of vascular complications and factors predictive of their development in young adults with type 1 diabetes: systematic literature review","volume":"7","author":"James","year":"2014","journal-title":"BMC Res Notes"},{"key":"key20180814084752091_ref1-bib17","volume-title":"National Diabetes Audit 2012\u20132013. Report 1: Care Processes and Treatment Targets","author":"Royal College of Paediatrics and Child Health","year":"2014"},{"key":"key20180814084752091_ref1-bib18","doi-asserted-by":"publisher","first-page":"729","DOI":"10.1002\/(SICI)1096-9136(199608)13:8<729::AID-DIA147>3.0.CO;2-A","article-title":"Social consequences of insulin-dependent diabetes mellitus are limited: a population-based comparison of young adult patients vs healthy controls","volume":"13","author":"Ingberg","year":"1996","journal-title":"Diabet Med"},{"key":"key20180814084752091_ref1-bib19","volume-title":"Diabetes (Type 1 and Type 2) in Children and Young People: Diagnosis and Management","author":"NICE","year":"2015"},{"key":"key20180814084752091_ref1-bib20","author":"Randell","year":"2012","journal-title":"Paediatric Diabetes Best Practice Tariff Criteria"},{"key":"key20180814084752091_ref1-bib21","doi-asserted-by":"publisher","first-page":"1876","DOI":"10.2337\/dc15-0780","article-title":"Rates of diabetic ketoacidosis: international comparison with 49,859 pediatric patients with type 1 diabetes from England, Wales, the US, Austria, and Germany","volume":"38","author":"Maahs","year":"2015","journal-title":"Diabetes Care"},{"key":"key20180814084752091_ref1-bib22","doi-asserted-by":"publisher","first-page":"1036","DOI":"10.1111\/dme.12676","article-title":"Glycaemic control of type\u20091 diabetes in clinical practice early in the 21st century: an international comparison","volume":"32","author":"McKnight","year":"2015","journal-title":"Diabet Med"},{"key":"key20180814084752091_ref1-bib23","doi-asserted-by":"publisher","first-page":"1481","DOI":"10.1080\/08035250600774114","article-title":"The impact of continuous subcutaneous insulin infusion on health-related quality of life in children and adolescents with type 1 diabetes","volume":"95","author":"J\u00fal\u00edusson","year":"2006","journal-title":"Acta Paediatr"},{"key":"key20180814084752091_ref1-bib24","doi-asserted-by":"publisher","first-page":"92","DOI":"10.1111\/j.1464-5491.2004.01359.x","article-title":"Insulin pump therapy in children and adolescents: improvements in key parameters of diabetes management including quality of life","volume":"22","author":"McMahon","year":"2005","journal-title":"Diabet Med"},{"key":"key20180814084752091_ref1-bib25","doi-asserted-by":"publisher","first-page":"2126","DOI":"10.1542\/peds.2005-2621","article-title":"Insulin pump therapy in youth with type 1 diabetes: a retrospective paired study","volume":"117","author":"Nimri","year":"2006","journal-title":"Pediatrics"},{"key":"key20180814084752091_ref1-bib26","doi-asserted-by":"publisher","first-page":"900","DOI":"10.1111\/j.1464-5491.2006.01935.x","article-title":"Long-term benefits of continuous subcutaneous insulin infusion in children with type 1 diabetes: a 4-year follow-up","volume":"23","author":"Sulli","year":"2006","journal-title":"Diabet Med"},{"key":"key20180814084752091_ref1-bib27","doi-asserted-by":"publisher","first-page":"393","DOI":"10.1515\/JPEM.2003.16.3.393","article-title":"Continuous subcutaneous insulin infusion in children and adolescents with diabetes mellitus: decreased HbA1c with low risk of hypoglycemia","volume":"16","author":"Sulli","year":"2003","journal-title":"J Pediatr Endocrinol Metab"},{"key":"key20180814084752091_ref1-bib28","doi-asserted-by":"publisher","first-page":"607","DOI":"10.1515\/JPEM.2002.15.5.607","article-title":"Weight in adolescents with type 1 diabetes mellitus during continuous subcutaneous insulin infusion (CSII) therapy","volume":"15","author":"Raile","year":"2002","journal-title":"J Pediatr Endocrinol Metab"},{"key":"key20180814084752091_ref1-bib29","doi-asserted-by":"publisher","first-page":"504","DOI":"10.1111\/pedi.12050","article-title":"Vascular function and glucose variability improve transiently following initiation of continuous subcutaneous insulin infusion in children with type 1 diabetes","volume":"14","author":"Harrington","year":"2013","journal-title":"Pediatr Diabetes"},{"key":"key20180814084752091_ref1-bib30","doi-asserted-by":"publisher","first-page":"175","DOI":"10.1089\/152091503321827830","article-title":"Glycemic, auxologic, and seasonal aspects of continuous subcutaneous insulin infusion therapy in children and young adults with type 1 diabetes","volume":"5","author":"Hathout","year":"2003","journal-title":"Diabetes Technol Ther"},{"key":"key20180814084752091_ref1-bib31","doi-asserted-by":"publisher","first-page":"587","DOI":"10.1089\/dia.2005.7.587","article-title":"Continuous subcutaneous insulin infusion and multiple dose of insulin regimen display similar patterns of blood glucose excursions in pediatric type 1 diabetes","volume":"7","author":"Alemzadeh","year":"2005","journal-title":"Diabetes Technol Ther"},{"key":"key20180814084752091_ref1-bib32","doi-asserted-by":"publisher","first-page":"641","DOI":"10.1111\/cen.12093","article-title":"Glycaemic variability in paediatric patients with type 1 diabetes on continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI): a cross-sectional cohort study","volume":"79","author":"Schreiver","year":"2013","journal-title":"Clin Endocrinol"},{"key":"key20180814084752091_ref1-bib33","doi-asserted-by":"publisher","first-page":"e0153033","DOI":"10.1371\/journal.pone.0153033","article-title":"Insulin pump therapy is associated with lower rates of retinopathy and peripheral nerve abnormality","volume":"11","author":"Zabeen","year":"2016","journal-title":"PLOS ONE"},{"key":"key20180814084752091_ref1-bib34","doi-asserted-by":"publisher","first-page":"677","DOI":"10.1001\/archpedi.158.7.677","article-title":"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","volume":"158","author":"Weintrob","year":"2004","journal-title":"Arch Pediatr Adolesc Med"},{"key":"key20180814084752091_ref1-bib35","doi-asserted-by":"publisher","first-page":"1554","DOI":"10.2337\/diacare.27.7.1554","article-title":"A randomized, prospective trial comparing the efficacy of continuous subcutaneous insulin infusion with multiple daily injections using insulin glargine","volume":"27","author":"Doyle","year":"2004","journal-title":"Diabetes Care"},{"key":"key20180814084752091_ref1-bib36","doi-asserted-by":"publisher","first-page":"87","DOI":"10.1007\/s00125-015-3790-6","article-title":"Use of insulin pump therapy in children and adolescents with type 1 diabetes and its impact on metabolic control: comparison of results from three large, transatlantic paediatric registries","volume":"59","author":"Sherr","year":"2016","journal-title":"Diabetologia"},{"key":"key20180814084752091_ref1-bib37","doi-asserted-by":"publisher","first-page":"491","DOI":"10.1111\/dme.12023","article-title":"Deprivation and ethnicity impact on diabetes control and use of treatment regimen","volume":"30","author":"Thompson","year":"2013","journal-title":"Diabet Med"},{"key":"key20180814084752091_ref1-bib38","doi-asserted-by":"publisher","first-page":"63","DOI":"10.1007\/s00592-016-0912-7","article-title":"Demographic and regional disparities in insulin pump utilization in a setting of universal funding: a New Zealand nationwide study","volume":"54","author":"McKergow","year":"2017","journal-title":"Acta Diabetol"},{"key":"key20180814084752091_ref1-bib39","doi-asserted-by":"publisher","first-page":"1508","DOI":"10.1111\/dme.13079","article-title":"Young people with type 1 diabetes of non-white ethnicity and lower socio-economic status have poorer glycaemic control in England and Wales","volume":"33","author":"Khanolkar","year":"2016","journal-title":"Diabet Med"},{"key":"key20180814084752091_ref1-bib40","doi-asserted-by":"publisher","first-page":"1047","DOI":"10.1515\/JPEM.2003.16.7.1047","article-title":"Continuous subcutaneous insulin infusion versus multiple daily injections in adolescents with type I diabetes mellitus: a randomized open crossover trial","volume":"16","author":"Cohen","year":"2003","journal-title":"J Pediatr Endocrinol Metab"},{"key":"key20180814084752091_ref1-bib41","doi-asserted-by":"publisher","first-page":"371","DOI":"10.1007\/BF02629260","article-title":"Short-term subcutaneous insulin infusion in diabetic children. Comparison with three daily insulin injections","volume":"19","author":"Meschi","year":"1982","journal-title":"Acta Diabetol Lat"},{"key":"key20180814084752091_ref1-bib42","doi-asserted-by":"publisher","first-page":"291","DOI":"10.1111\/j.1399-5448.2008.00396.x","article-title":"Effects of insulin pump vs. injection treatment on quality of life and impact of disease in children with type 1 diabetes mellitus in a randomized, prospective comparison","volume":"9","author":"Nuboer","year":"2008","journal-title":"Pediatr Diabetes"},{"key":"key20180814084752091_ref1-bib43","doi-asserted-by":"publisher","first-page":"472","DOI":"10.1111\/j.1399-5448.2008.00390.x","article-title":"Improved treatment satisfaction but no difference in metabolic control when using continuous subcutaneous insulin infusion vs. multiple daily injections in children at onset of type 1 diabetes mellitus","volume":"9","author":"Skogsberg","year":"2008","journal-title":"Pediatr Diabetes"},{"key":"key20180814084752091_ref1-bib44","doi-asserted-by":"publisher","first-page":"380","DOI":"10.1016\/j.jpeds.2004.06.022","article-title":"A randomized, controlled study of insulin pump therapy in diabetic preschoolers","volume":"145","author":"DiMeglio","year":"2004","journal-title":"J Pediatr"},{"key":"key20180814084752091_ref1-bib45","doi-asserted-by":"publisher","first-page":"1277","DOI":"10.2337\/diacare.28.6.1277","article-title":"A randomized controlled trial of insulin pump therapy in young children with type 1 diabetes","volume":"28","author":"Fox","year":"2005","journal-title":"Diabetes Care"},{"key":"key20180814084752091_ref1-bib46","doi-asserted-by":"publisher","first-page":"559","DOI":"10.1542\/peds.112.3.559","article-title":"Comparison of continuous subcutaneous insulin infusion and multiple daily injection regimens in children with type 1 diabetes: a randomized open crossover trial","volume":"112","author":"Weintrob","year":"2003","journal-title":"Pediatrics"},{"key":"key20180814084752091_ref1-bib47","doi-asserted-by":"publisher","first-page":"15","DOI":"10.2337\/diacare.28.1.15","article-title":"A two-center randomized controlled feasibility trial of insulin pump therapy in young children with diabetes","volume":"28","author":"Wilson","year":"2005","journal-title":"Diabetes Care"},{"key":"key20180814084752091_ref1-bib48","doi-asserted-by":"publisher","first-page":"202","DOI":"10.1111\/j.1399-5448.2008.00494.x","article-title":"A randomized prospective study of insulin pump vs. insulin injection therapy in very young children with type 1 diabetes: 12-month glycemic, BMI, and neurocognitive outcomes","volume":"10","author":"Nabhan","year":"2009","journal-title":"Pediatr Diabetes"},{"key":"key20180814084752091_ref1-bib49","doi-asserted-by":"publisher","first-page":"52","DOI":"10.1111\/j.1399-5448.2008.00440.x","article-title":"Continuous subcutaneous insulin infusion vs. multiple daily injections in children with type 1 diabetes: a systematic review and meta-analysis of randomized control trials","volume":"10","author":"Pa\u0144kowska","year":"2009","journal-title":"Pediatr Diabetes"},{"key":"key20180814084752091_ref1-bib50","doi-asserted-by":"publisher","first-page":"116","DOI":"10.1111\/j.1399-5448.2009.00546.x","article-title":"Discontinuation of insulin pump treatment in children, adolescents, and young adults. A multicenter analysis based on the DPV database in Germany and Austria","volume":"11","author":"Hofer","year":"2010","journal-title":"Pediatr Diabetes"},{"key":"key20180814084752091_ref1-bib51","doi-asserted-by":"publisher","first-page":"506","DOI":"10.1111\/j.1399-5448.2010.00701.x","article-title":"Factors associated with increased risk of insulin pump discontinuation in pediatric patients with type 1 diabetes","volume":"12","author":"de Vries","year":"2011","journal-title":"Pediatr Diabetes"},{"key":"key20180814084752091_ref1-bib52","doi-asserted-by":"publisher","first-page":"2355","DOI":"10.2337\/dc06-1141","article-title":"Durability of insulin pump use in pediatric patients with type 1 diabetes","volume":"29","author":"Wood","year":"2006","journal-title":"Diabetes Care"},{"key":"key20180814084752091_ref1-bib53","doi-asserted-by":"publisher","first-page":"99","DOI":"10.1007\/s00592-011-0344-3","article-title":"Failure of glycated hemoglobin drop after continuous subcutaneous insulin infusion initiation may indicate patients who discontinue: a 4-year follow-up study in children and adolescents with type 1 diabetes","volume":"49","author":"Lombardo","year":"2012","journal-title":"Acta Diabetologica"},{"key":"key20180814084752091_ref1-bib54","doi-asserted-by":"publisher","first-page":"131","DOI":"10.1089\/dia.2008.0042","article-title":"Factors associated with adherence to continuous subcutaneous insulin infusion in pediatric diabetes","volume":"11","author":"Babar","year":"2009","journal-title":"Diabetes Technol Ther"},{"key":"key20180814084752091_ref1-bib55","doi-asserted-by":"publisher","first-page":"65","DOI":"10.18544\/PEDM-21.02.0026","article-title":"Reasons for the discontinuation of therapy of personal insulin pump in children with type 1 diabetes","volume":"21","author":"Binek","year":"2016","journal-title":"Pediatr Endocrinol Diabetes Metab"},{"key":"key20180814084752091_ref1-bib56","doi-asserted-by":"publisher","first-page":"627","DOI":"10.1111\/dme.12683","article-title":"Parents\u2019 experiences of managing their child\u2019s diabetes using an insulin pump: a qualitative study","volume":"32","author":"Rankin","year":"2015","journal-title":"Diabet Med"},{"key":"key20180814084752091_ref1-bib57","doi-asserted-by":"publisher","first-page":"1023","DOI":"10.1007\/s11096-014-9990-1","article-title":"Insulin pump therapy: impact on the lives of children\/young people with diabetes mellitus and their parents","volume":"36","author":"Alsaleh","year":"2014","journal-title":"Int J Clin Pharm"},{"key":"key20180814084752091_ref1-bib58","doi-asserted-by":"publisher","first-page":"855","DOI":"10.1111\/j.1464-5491.2012.03698.x","article-title":"Estimating the current and future costs of type 1 and type 2 diabetes in the UK, including direct health costs and indirect societal and productivity costs","volume":"29","author":"Hex","year":"2012","journal-title":"Diabet Med"},{"key":"key20180814084752091_ref1-bib59","volume-title":"Diabetes Expenditure, Burden of Disease and Management in 5 EU Countries","author":"Kanavos","year":"2012"},{"key":"key20180814084752091_ref1-bib60","volume-title":"Diabetes: Facts and Stats. Version 3","author":"Diabetes UK","year":"2014"},{"key":"key20180814084752091_ref1-bib61","volume-title":"National Paediatric Diabetes Audit Reports","author":"Royal College of Paediatrics and Child Health","year":"2015"},{"key":"key20180814084752091_ref1-bib62","doi-asserted-by":"publisher","first-page":"1239","DOI":"10.1111\/j.1464-5491.2005.01576.x","article-title":"Health-economic comparison of continuous subcutaneous insulin infusion with multiple daily injection for the treatment of type 1 diabetes in the UK","volume":"22","author":"Roze","year":"2005","journal-title":"Diabet Med"},{"key":"key20180814084752091_ref1-bib63","doi-asserted-by":"publisher","first-page":"103","DOI":"10.1111\/j.1399-5448.2007.00232.x","article-title":"ISPAD clinical practice consensus guidelines 2006\u20132007. Diabetes education","volume":"8","author":"Swift","year":"2007","journal-title":"Pediatr Diabetes"},{"key":"key20180814084752091_ref1-bib64","doi-asserted-by":"publisher","first-page":"163","DOI":"10.1186\/s13063-015-0658-5","article-title":"Study protocol for a randomised controlled trial of insulin delivery by continuous subcutaneous infusion compared to multiple daily injections","volume":"16","author":"Blair","year":"2015","journal-title":"Trials"},{"key":"key20180814084752091_ref1-bib65","volume-title":"The Medical Devices Regulations 2002","author":"Great Britain","year":"2002"},{"key":"key20180814084752091_ref1-bib66","volume-title":"Directive 2001\/20\/EC of the European Parliament and of the Council of 4 April 2001","author":"European Commission","year":"2001"},{"key":"key20180814084752091_ref1-bib67","volume-title":"Medicines for Human Use (Clinical Trials) Regulations 2004","author":"Great Britain","year":"2004"},{"key":"key20180814084752091_ref1-bib68","doi-asserted-by":"publisher","first-page":"7","DOI":"10.1186\/1471-2431-11-7","article-title":"Delivering Early Care In Diabetes Evaluation (DECIDE): a protocol for a randomised controlled trial to assess hospital versus home management at diagnosis in childhood diabetes","volume":"11","author":"Townson","year":"2011","journal-title":"BMC Pediatrics"},{"key":"key20180814084752091_ref1-bib69","volume-title":"Diagnosis of Diabetes Mellitus and Intermediate Hyperglycemia: Report of a WHO\/IDF Consultation","author":"World Health Organization (WHO)","year":"2006"},{"key":"key20180814084752091_ref1-bib70","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/j.diabres.2005.02.004","article-title":"Therapy with insulin glargine (Lantus) in toddlers, children and adolescents with type 1 diabetes","volume":"70","author":"Colino","year":"2005","journal-title":"Diabetes Res Clin Pract"},{"key":"key20180814084752091_ref1-bib71","doi-asserted-by":"publisher","first-page":"216","DOI":"10.1111\/dme.12041","article-title":"Insulin analogues in children with type 1 diabetes: a 52-week randomized clinical trial","volume":"30","author":"Thalange","year":"2013","journal-title":"Diabet Med"},{"key":"key20180814084752091_ref1-bib72","volume-title":"Pumping Insulin. Everything You Need for Success on a Smart Insulin Pump","author":"Walsh","year":"2006","edition":"4th edn."},{"key":"key20180814084752091_ref1-bib73","doi-asserted-by":"publisher","first-page":"78","DOI":"10.1515\/CCLM.2002.016","article-title":"Approved IFCC reference method for the measurement of HbA1c in human blood","volume":"40","author":"Jeppsson","year":"2002","journal-title":"Clin Chem Lab Med"},{"key":"key20180814084752091_ref1-bib74","doi-asserted-by":"publisher","first-page":"517","DOI":"10.1186\/s13063-016-1640-6","article-title":"Measurement of HbA1c in multicentre diabetes trials \u2013 should blood samples be tested locally or sent to a central laboratory: an agreement analysis","volume":"17","author":"Arch","year":"2016","journal-title":"Trials"},{"key":"key20180814084752091_ref1-bib75","doi-asserted-by":"publisher","first-page":"1245","DOI":"10.2337\/diacare.28.5.1245","article-title":"Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia","volume":"28","author":"Workgroup on Hypoglycemia, American Diabetes Association","year":"2005","journal-title":"Diabetes Care"},{"key":"key20180814084752091_ref1-bib76","doi-asserted-by":"publisher","first-page":"e133","DOI":"10.1542\/peds.113.2.e133","article-title":"European Society for Paediatric Endocrinology\/Lawson Wilkins Pediatric Endocrine Society consensus statement on diabetic ketoacidosis in children and adolescents","volume":"113","author":"Dunger","year":"2004","journal-title":"Pediatrics"},{"key":"key20180814084752091_ref1-bib77","volume-title":"WHO Child Growth Standards: LengthHeight-for-Age, Weight-for-Age, Weight-for-Length, Weight-for-Height and Body Mass Index-For-Age: Methods and Development","author":"World Health Organization (WHO) Multicentre Growth Reference Study Group","year":"2006"},{"key":"key20180814084752091_ref1-bib78","doi-asserted-by":"publisher","first-page":"660","DOI":"10.2471\/BLT.07.043497","article-title":"Development of a WHO growth reference for school-aged children and adolescents","volume":"85","author":"de Onis","year":"2007","journal-title":"Bull World Health Organ"},{"key":"key20180814084752091_ref1-bib79","doi-asserted-by":"publisher","first-page":"631","DOI":"10.2337\/diacare.26.3.631","article-title":"The PedsQL in type 1 and type 2 diabetes: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales and type 1 Diabetes Module","volume":"26","author":"Varni","year":"2003","journal-title":"Diabetes Care"},{"key":"key20180814084752091_ref1-bib80","doi-asserted-by":"publisher","first-page":"2169","DOI":"10.1007\/s11136-012-0339-8","article-title":"Content validity of the PedsQL\u2122 3.2 Diabetes Module in newly diagnosed patients with type 1 diabetes mellitus ages 8\u201345","volume":"22","author":"Varni","year":"2013","journal-title":"Qual Life Res"},{"issue":"43","key":"key20180814084752091_ref1-bib81","doi-asserted-by":"publisher","DOI":"10.3310\/hta8430","article-title":"Clinical and cost-effectiveness of continuous subcutaneous insulin infusion for diabetes","volume":"8","author":"Colquitt","year":"2004","journal-title":"Health Technol Assess"},{"key":"key20180814084752091_ref1-bib82","doi-asserted-by":"publisher","first-page":"1232","DOI":"10.2337\/diacare.23.9.1232","article-title":"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","volume":"23","author":"Hanaire-Broutin","year":"2000","journal-title":"Diabetes Care"},{"key":"key20180814084752091_ref1-bib83","first-page":"155","article-title":"Multiple insulin injections using a pen injector versus insulin pump treatment in young diabetic patients","volume":"6","author":"Bak","year":"1987","journal-title":"Diabetes Res"},{"key":"key20180814084752091_ref1-bib84","doi-asserted-by":"publisher","first-page":"324","DOI":"10.2337\/diacare.19.4.324","article-title":"Reduction in severe hypoglycemia with long-term continuous subcutaneous insulin infusion in type I diabetes","volume":"19","author":"Bode","year":"1996","journal-title":"Diabetes Care"},{"key":"key20180814084752091_ref1-bib85","doi-asserted-by":"publisher","first-page":"331","DOI":"10.2337\/diacare.7.4.331","article-title":"Continuous subcutaneous insulin infusion (Mill-Hill Infuser) versus multiple injections (Medi-Jector) in the treatment of insulin-dependent diabetes mellitus and the effect of metabolic control on microangiopathy","volume":"7","author":"Chiasson","year":"1984","journal-title":"Diabetes Care"},{"key":"key20180814084752091_ref1-bib86","doi-asserted-by":"publisher","first-page":"457","DOI":"10.1111\/j.1365-2796.1990.tb00263.x","article-title":"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","volume":"228","author":"Haakens","year":"1990","journal-title":"J Intern Med"},{"key":"key20180814084752091_ref1-bib87","doi-asserted-by":"publisher","first-page":"466","DOI":"10.2337\/diacare.5.5.466","article-title":"A crossover comparison of continuous subcutaneous insulin infusion (CSII) against multiple insulin injections in insulin-dependent diabetic subjects: improved control with CSII","volume":"5","author":"Home","year":"1982","journal-title":"Diabetes Care"},{"key":"key20180814084752091_ref1-bib88","doi-asserted-by":"publisher","first-page":"31","DOI":"10.7326\/0003-4819-97-1-31","article-title":"Intensive conventional and insulin pump therapies in adult type I diabetes. A crossover study","volume":"97","author":"Nathan","year":"1982","journal-title":"Ann Intern Med"},{"key":"key20180814084752091_ref1-bib89","first-page":"289","article-title":"Frequency of hypoglycaemic and hyperglycaemic\u2013ketotic episodes during conventional and subcutaneous continuous insulin infusion therapy in IDDM","volume":"1","author":"Nosadini","year":"1988","journal-title":"Diabetes Nutr Metab"},{"key":"key20180814084752091_ref1-bib90","doi-asserted-by":"publisher","first-page":"150","DOI":"10.1111\/j.1464-5491.1988.tb00962.x","article-title":"Comparison of continuous subcutaneous insulin infusion with multiple insulin injections using the NovoPen","volume":"5","author":"Saurbrey","year":"1988","journal-title":"Diabet Med"},{"key":"key20180814084752091_ref1-bib91","doi-asserted-by":"publisher","first-page":"255","DOI":"10.2337\/diab.31.3.255","article-title":"Comparison between continuous subcutaneous insulin infusion and multiple injections of insulin. A one-year prospective study","volume":"31","author":"Schiffrin","year":"1982","journal-title":"Diabetes"},{"key":"key20180814084752091_ref1-bib92","first-page":"176","article-title":"Effect of pump versus pen treatment on glycaemic control and kidney function in long-term uncomplicated insulin-dependent diabetes mellitus (IDDM)","volume":"36","author":"Schmitz","year":"1989","journal-title":"Dan Med Bull"},{"key":"key20180814084752091_ref1-bib93","doi-asserted-by":"publisher","first-page":"1722","DOI":"10.2337\/diacare.24.10.1722","article-title":"Intensive insulin therapy with insulin lispro: a randomized trial of continuous subcutaneous insulin infusion versus multiple daily insulin injection","volume":"24","author":"Tsui","year":"2001","journal-title":"Diabetes Care"},{"key":"key20180814084752091_ref1-bib94","first-page":"203","article-title":"Comparison of continuous subcutaneous insulin infusion and intensified conventional therapy in the treatment of type I diabetes: a two year randomized study","volume":"3","author":"Ziegler","year":"1990","journal-title":"Diabetes Nutr Metab Clin Exp"},{"key":"key20180814084752091_ref1-bib95","doi-asserted-by":"publisher","first-page":"104","DOI":"10.1159\/000293680","article-title":"Complications and fetal outcome in diabetic pregnancy. Intensified conventional versus insulin pump therapy","volume":"26","author":"Burkart","year":"1988","journal-title":"Gynecol Obstet Invest"},{"key":"key20180814084752091_ref1-bib96","first-page":"121","article-title":"Continuous subcutaneous insulin infusion versus intensive conventional insulin therapy in type I and type II diabetic pregnancy","volume":"12","author":"Carta","year":"1986","journal-title":"Diabetes Metab"},{"key":"key20180814084752091_ref1-bib97","doi-asserted-by":"publisher","first-page":"631","DOI":"10.1001\/jama.1986.03370050073024","article-title":"A randomized clinical trial of the insulin pump vs intensive conventional therapy in diabetic pregnancies","volume":"255","author":"Coustan","year":"1986","journal-title":"JAMA"},{"key":"key20180814084752091_ref1-bib98","first-page":"33","article-title":"Is continuous subcutaneous insulin infusion more effective than intensive conventional insulin therapy in the treatment of pregnant diabetic women?","volume":"6","author":"Nosari","year":"1993","journal-title":"Diabetes Nutr Metab"},{"key":"key20180814084752091_ref1-bib99","doi-asserted-by":"publisher","first-page":"255","DOI":"10.2337\/diacare.7.3.255","article-title":"Metabolic response to fasting exercise in adolescent insulin-dependent diabetic subjects treated with continuous subcutaneous insulin infusion and intensive conventional therapy","volume":"7","author":"Schiffrin","year":"1984","journal-title":"Diabetes Care"},{"key":"key20180814084752091_ref1-bib100","first-page":"24","article-title":"Comparison of continuous subcutaneous insulin infusion versus multiple daily injections in adolescents with insulin-dependent diabetes","volume":"2","author":"Tamborlane","year":"1989","journal-title":"Adv Diabetol"},{"key":"key20180814084752091_ref1-bib101","doi-asserted-by":"publisher","first-page":"726","DOI":"10.7326\/0003-4819-152-11-201006010-00232","article-title":"CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials","volume":"152","author":"Schulz","year":"2010","journal-title":"Ann Intern Med"},{"key":"key20180814084752091_ref1-bib102","volume-title":"Topic E9 Statistical Principles for Clinical Trials. (CPMP\/ICH\/363\/96)","author":"International Conference on Harmonisation","year":"1998"},{"key":"key20180814084752091_ref1-bib103","doi-asserted-by":"publisher","DOI":"10.3310\/hta14110","article-title":"Clinical effectiveness and cost-effectiveness of continuous subcutaneous insulin infusion for diabetes: systematic review and economic evaluation","volume":"14","author":"Cummins","year":"2010","journal-title":"Health Technol Assess"},{"key":"key20180814084752091_ref1-bib104","doi-asserted-by":"publisher","first-page":"1415","DOI":"10.1111\/dme.12792","article-title":"Cost-effectiveness of continuous subcutaneous insulin infusion versus multiple daily injections of insulin in type 1 diabetes: a systematic review","volume":"32","author":"Roze","year":"2015","journal-title":"Diabet Med"},{"key":"key20180814084752091_ref1-bib105","doi-asserted-by":"publisher","first-page":"21","DOI":"10.1002\/dmrr.2653","article-title":"Continuous subcutaneous insulin infusion in diabetes: patient populations, safety, efficacy, and pharmacoeconomics","volume":"32","author":"Pozzilli","year":"2016","journal-title":"Diabetes Metab Res Rev"},{"key":"key20180814084752091_ref1-bib106","doi-asserted-by":"publisher","first-page":"881","DOI":"10.2165\/00019053-200725100-00006","article-title":"Continuous subcutaneous insulin infusion versus multiple daily injections of insulin: economic comparison in adult and adolescent type 1 diabetes mellitus in Australia","volume":"25","author":"Cohen","year":"2007","journal-title":"PharmacoEconomics"},{"key":"key20180814084752091_ref1-bib107","doi-asserted-by":"publisher","first-page":"674","DOI":"10.1111\/j.1524-4733.2008.00478.x","article-title":"A cost-effectiveness analysis of continuous subcutaneous insulin injection versus multiple daily injections in type 1 diabetes patients: a third-party US payer perspective","volume":"12","author":"St Charles","year":"2009","journal-title":"Value Health"},{"key":"key20180814084752091_ref1-bib108","first-page":"679","article-title":"Cost-utility analysis of insulin pumps compared to multiple daily doses of insulin in patients with type 1 diabetes mellitus in Spain","volume":"80","author":"Conget","year":"2006","journal-title":"Rev Esp Salud Publica"},{"key":"key20180814084752091_ref1-bib109","first-page":"2020","article-title":"Cost-effectiveness of continuous subcutaneous insulin infusion therapy for type 1 diabetes","volume":"172","author":"N\u00f8rgaard","year":"2010","journal-title":"Ugeskr Laeger"},{"key":"key20180814084752091_ref1-bib110","doi-asserted-by":"publisher","first-page":"155","DOI":"10.1186\/1471-2431-13-155","article-title":"Economic evaluation of continuous subcutaneous insulin infusion for children with diabetes - a pilot study: CSII application for children \u2013 economic evaluation","volume":"13","author":"Petkova","year":"2013","journal-title":"BMC Pediatr"},{"key":"key20180814084752091_ref1-bib111","doi-asserted-by":"crossref","first-page":"586","DOI":"10.1046\/j.1464-5491.2003.00991.x","article-title":"The cost-effectiveness of continuous subcutaneous insulin infusion compared with multiple daily injections for the management of diabetes","volume":"20","author":"Scuffham","year":"2003","journal-title":"Diabet Med"},{"key":"key20180814084752091_ref1-bib112","doi-asserted-by":"publisher","first-page":"657","DOI":"10.1016\/j.clinthera.2009.03.013","article-title":"Health economic comparison between continuous subcutaneous insulin infusion and multiple daily injections of insulin for the treatment of adult type 1 diabetes in Canada","volume":"31","author":"St Charles","year":"2009","journal-title":"Clin Ther"},{"key":"key20180814084752091_ref1-bib113","doi-asserted-by":"publisher","first-page":"1974","DOI":"10.2337\/diacare.28.8.1974","article-title":"Discordant trends in microvascular complications in adolescents with type 1 diabetes from 1990 to 2002","volume":"28","author":"Mohsin","year":"2005","journal-title":"Diabetes Care"},{"key":"key20180814084752091_ref1-bib114","volume-title":"Australian National Diabetes Information Audit and Benchmarking","author":"National Association of Diabetes Centres","year":"2004"},{"key":"key20180814084752091_ref1-bib115","doi-asserted-by":"publisher","first-page":"1079","DOI":"10.2337\/diacare.26.4.1079","article-title":"Insulin pump therapy: a meta-analysis","volume":"26","author":"Weissberg-Benchell","year":"2003","journal-title":"Diabetes Care"},{"key":"key20180814084752091_ref1-bib116","doi-asserted-by":"publisher","first-page":"746","DOI":"10.1046\/j.1464-5491.2002.00713.x","article-title":"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","volume":"19","author":"Linkeschova","year":"2002","journal-title":"Diabet Med"},{"key":"key20180814084752091_ref1-bib117","doi-asserted-by":"publisher","first-page":"2254","DOI":"10.1001\/jama.289.17.2254","article-title":"Outpatient insulin therapy in type 1 and type 2 diabetes mellitus: scientific review","volume":"289","author":"DeWitt","year":"2003","journal-title":"JAMA"},{"key":"key20180814084752091_ref1-bib118","doi-asserted-by":"publisher","first-page":"14","DOI":"10.1002\/dmrr.205","article-title":"Diabetes management in the new millennium using insulin pump therapy","volume":"18","author":"Bode","year":"2002","journal-title":"Diabetes Metab Res Rev"},{"key":"key20180814084752091_ref1-bib119","doi-asserted-by":"publisher","first-page":"628","DOI":"10.1046\/j.1464-5491.2002.00750.x","article-title":"Continuous subcutaneous insulin infusion (CSII) in the Veneto region: efficacy, acceptability and quality of life","volume":"19","author":"Bruttomesso","year":"2002","journal-title":"Diabet Med"},{"key":"key20180814084752091_ref1-bib120","doi-asserted-by":"publisher","first-page":"714","DOI":"10.1016\/j.jval.2014.07.007","article-title":"Validation of the IMS CORE Diabetes Model","volume":"17","author":"McEwan","year":"2014","journal-title":"Value Health"},{"key":"key20180814084752091_ref1-bib121","volume-title":"National Tariff 2016\u20132017 Annex A","author":"NHS England","year":"2016"},{"key":"key20180814084752091_ref1-bib122","volume-title":"National Schedule 2014\u20132015","author":"Department of Health and Social Care","year":"2015"},{"key":"key20180814084752091_ref1-bib123","volume-title":"Unit Costs of Health and Social Care 2015","author":"Curtis","year":"2015"},{"key":"key20180814084752091_ref1-bib124","volume-title":"British National Formulary","author":"Joint Formulary Committee","year":"2015","edition":"69th edn."},{"key":"key20180814084752091_ref1-bib125","doi-asserted-by":"publisher","first-page":"1201","DOI":"10.1002\/hec.1785","article-title":"Spoilt for choice: implications of using alternative methods of costing hospital episode statistics","volume":"21","author":"Geue","year":"2012","journal-title":"Health Econ"},{"key":"key20180814084752091_ref1-bib126","doi-asserted-by":"publisher","first-page":"e0135672","DOI":"10.1371\/journal.pone.0135672","article-title":"Measuring health utilities in children and adolescents: a systematic review of the literature","volume":"10","author":"Thorrington","year":"2015","journal-title":"PLOS ONE"},{"key":"key20180814084752091_ref1-bib127","doi-asserted-by":"publisher","first-page":"12","DOI":"10.1186\/1477-7525-8-12","article-title":"A review of health utilities across conditions common in paediatric and adult populations","volume":"8","author":"Tarride","year":"2010","journal-title":"Health Qual Life Outcomes"},{"key":"key20180814084752091_ref1-bib128","volume-title":"Guide to the Methods of Technology Appraisal","author":"NICE","year":"2008"},{"key":"key20180814084752091_ref1-bib129","doi-asserted-by":"publisher","first-page":"627","DOI":"10.1097\/01.mlr.0000163666.00471.8e","article-title":"Utility scores for the Health Utilities Index Mark 2: an empirical assessment of alternative mapping functions","volume":"43","author":"McCabe","year":"2005","journal-title":"Med Care"},{"key":"key20180814084752091_ref1-bib130","doi-asserted-by":"publisher","first-page":"779","DOI":"10.1002\/hec.635","article-title":"Representing uncertainty: the role of cost-effectiveness acceptability curves","volume":"10","author":"Fenwick","year":"2001","journal-title":"Health Econ"},{"key":"key20180814084752091_ref1-bib131","volume-title":"Guide to the Methods of Technology Appraisal 2013. Process and Methods [PMG9]","author":"NICE","year":"2013"},{"key":"key20180814084752091_ref1-bib132","volume-title":"Health Utilities Index (HUI) Procedures Manual: Algorithm for Determining HUI Mark 2 (HUI2)\/Mark 3 (HUI3) Health Status Classification Levels, Health States Single-attribute Level Utility Scores and Overall Health-related Quality of Life Utility Scores from 15-item Self-complete Health Status Questionnaires","author":"Furlong","year":"2002"},{"key":"key20180814084752091_ref1-bib133","doi-asserted-by":"publisher","first-page":"377","DOI":"10.1002\/sim.4067","article-title":"Multiple imputation using chained equations: issues and guidance for practice","volume":"30","author":"White","year":"2011","journal-title":"Stat Med"},{"key":"key20180814084752091_ref1-bib134","doi-asserted-by":"publisher","first-page":"f1049","DOI":"10.1136\/bmj.f1049","article-title":"Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement","volume":"346","author":"Husereau","year":"2013","journal-title":"BMJ"},{"key":"key20180814084752091_ref1-bib135","doi-asserted-by":"publisher","first-page":"217","DOI":"10.1002\/hec.1008","article-title":"Methods for incorporating covariate adjustment, subgroup analysis and between-centre differences into cost-effectiveness evaluations","volume":"14","author":"Nixon","year":"2005","journal-title":"Health Econ"},{"key":"key20180814084752091_ref1-bib136","doi-asserted-by":"publisher","first-page":"S5","DOI":"10.1185\/030079904X1980","article-title":"The CORE Diabetes Model: projecting long-term clinical outcomes, costs and costeffectiveness of interventions in diabetes mellitus (types 1 and 2) to support clinical and reimbursement decision-making","volume":"20","author":"Palmer","year":"2004","journal-title":"Curr Med Res Opin"},{"key":"key20180814084752091_ref1-bib137","doi-asserted-by":"publisher","first-page":"E924","DOI":"10.1152\/ajpendo.2001.281.5.E924","article-title":"Intermittent high glucose enhances apoptosis in human umbilical vein endothelial cells in culture","volume":"281","author":"Risso","year":"2001","journal-title":"Am J Physiol Endocrinol Metab"},{"key":"key20180814084752091_ref1-bib138","doi-asserted-by":"publisher","first-page":"234","DOI":"10.1002\/dmrr.680","article-title":"Gliclazide protects human islet beta-cells from apoptosis induced by intermittent high glucose","volume":"23","author":"Del Guerra","year":"2007","journal-title":"Diabetes Metab Res Rev"},{"key":"key20180814084752091_ref1-bib139","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/j.diabres.2016.02.006","article-title":"Effect of glucose variability on pathways associated with glucotoxicity in diabetes: Evaluation of a novel in vitro experimental approach","volume":"114","author":"Kuricov\u00e1","year":"2016","journal-title":"Diabetes Res Clin Pract"},{"key":"key20180814084752091_ref1-bib140","doi-asserted-by":"publisher","first-page":"326","DOI":"10.1111\/j.1464-5491.2007.02365.x","article-title":"In type 1 diabetic patients with good glycaemic control, blood glucose variability is lower during continuous subcutaneous insulin infusion than during multiple daily injections with insulin glargine","volume":"25","author":"Bruttomesso","year":"2008","journal-title":"Diabet Med"},{"key":"key20180814084752091_ref1-bib141","doi-asserted-by":"publisher","first-page":"288","DOI":"10.1111\/j.1463-1326.2009.01160.x","article-title":"Glycaemic variability and complications in patients with diabetes mellitus: evidence from a systematic review of the literature","volume":"12","author":"Nalysnyk","year":"2010","journal-title":"Diabetes Obes Metab"},{"key":"key20180814084752091_ref1-bib142","doi-asserted-by":"publisher","first-page":"48","DOI":"10.17140\/DROJ-1-108","article-title":"Glycemic variability: clinical and prognostic significance","volume":"1","author":"Lin","year":"2015","journal-title":"Diabetes Res Open J"},{"key":"key20180814084752091_ref1-bib143","doi-asserted-by":"publisher","first-page":"428","DOI":"10.1111\/pedi.12413","article-title":"Factors contributing to partial remission in type 1 diabetes: analysis based on the insulin dose-adjusted HbA1c in 3657 children and adolescents from Germany and Austria","volume":"18","author":"Nagl","year":"2016","journal-title":"Pediatr Diabetes"},{"key":"key20180814084752091_ref1-bib144","doi-asserted-by":"publisher","first-page":"1105","DOI":"10.1016\/j.jdiacomp.2015.09.002","article-title":"Influence of remission and its duration on development of early microvascular complications in young adults with type 1 diabetes","volume":"29","author":"Niedzwiecki","year":"2015","journal-title":"J Diabetes Complications"},{"key":"key20180814084752091_ref1-bib145","doi-asserted-by":"publisher","first-page":"410","DOI":"10.1136\/adc.75.5.410","article-title":"Ketoacidosis at the diagnosis of type 1 (insulin dependent) diabetes mellitus is related to poor residual beta cell function. Childhood Diabetes in Finland Study Group","volume":"75","author":"Komulainen","year":"1996","journal-title":"Arch Dis Child"},{"key":"key20180814084752091_ref1-bib146","doi-asserted-by":"publisher","first-page":"250","DOI":"10.2337\/diabetes.53.1.250","article-title":"C-peptide is the appropriate outcome measure for type 1 diabetes clinical trials to preserve beta-cell function: report of an ADA workshop, 21\u201322 October 2001","volume":"53","author":"Palmer","year":"2004","journal-title":"Diabetes"},{"key":"key20180814084752091_ref1-bib147","doi-asserted-by":"publisher","first-page":"1384","DOI":"10.2337\/dc08-1987","article-title":"New definition for the partial remission period in children and adolescents with type 1 diabetes","volume":"32","author":"Mortensen","year":"2009","journal-title":"Diabetes Care"},{"key":"key20180814084752091_ref1-bib148","doi-asserted-by":"publisher","first-page":"479","DOI":"10.1542\/peds.109.3.479","article-title":"Stature at time of diagnosis of type 1 diabetes mellitus","volume":"109","author":"DiLiberti","year":"2002","journal-title":"Pediatrics"},{"key":"key20180814084752091_ref1-bib149","doi-asserted-by":"publisher","first-page":"1779","DOI":"10.2337\/diacare.22.11.1779","article-title":"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","volume":"22","author":"Boland","year":"1999","journal-title":"Diabetes Care"},{"key":"key20180814084752091_ref1-bib150","doi-asserted-by":"publisher","first-page":"204","DOI":"10.1089\/dia.2013.0315","article-title":"Family perceptions of insulin pump adverse events in children and adolescents","volume":"16","author":"Wheeler","year":"2014","journal-title":"Diabetes Technol Ther"},{"key":"key20180814084752091_ref1-bib151","doi-asserted-by":"publisher","first-page":"1095","DOI":"10.1177\/193229681300700435","article-title":"Insulin pump therapy in children with type 1 diabetes: the dark side of the moon","volume":"7","author":"Scaramuzza","year":"2013","journal-title":"J Diabetes Sci Technol"},{"key":"key20180814084752091_ref1-bib152","doi-asserted-by":"publisher","first-page":"1017","DOI":"10.1007\/s00592-015-0784-2","article-title":"Clinical review: insulin pump-associated adverse events in adults and children","volume":"52","author":"Ross","year":"2015","journal-title":"Acta Diabetol"},{"key":"key20180814084752091_ref1-bib153","doi-asserted-by":"publisher","first-page":"991","DOI":"10.1007\/s00592-016-0897-2","article-title":"Insulin pump-associated adverse events are common, but not associated with glycemic control, socio-economic status, or pump\/infusion set type","volume":"53","author":"Ross","year":"2016","journal-title":"Acta Diabetol"},{"key":"key20180814084752091_ref1-bib154","doi-asserted-by":"publisher","first-page":"1113","DOI":"10.1007\/s11136-015-1158-5","article-title":"Whose quality of life is it anyway? Discrepancies between youth and parent health-related quality of life ratings in type 1 and type 2 diabetes","volume":"25","author":"Yi-Frazier","year":"2016","journal-title":"Qual Life Res"},{"key":"key20180814084752091_ref1-bib155","doi-asserted-by":"publisher","first-page":"64","DOI":"10.1016\/j.healthpol.2015.10.006","article-title":"Valuing technology: a qualitative interview study with physicians about insulin pump therapy for children with type 1 diabetes","volume":"120","author":"Shulman","year":"2016","journal-title":"Health Policy"},{"key":"key20180814084752091_ref1-bib156","doi-asserted-by":"publisher","first-page":"929","DOI":"10.1089\/dia.2013.0132","article-title":"Race, socioeconomic status, and treatment center are associated with insulin pump therapy in youth in the first year following diagnosis of type 1 diabetes","volume":"15","author":"Lin","year":"2013","journal-title":"Diabetes Technol Ther"},{"key":"key20180814084752091_ref1-bib157","doi-asserted-by":"publisher","first-page":"99","DOI":"10.1055\/s-0042-101155","article-title":"Use and effectiveness of Continuous Subcutaneous Insulin Infusion (CSII) and Multiple Daily Insulin Injection Therapy (MIT) in children, adolescents and young adults with type 1 diabetes mellitus","volume":"124","author":"Schiel","year":"2016","journal-title":"Exp Clin Endocrinol Diabetes"},{"key":"key20180814084752091_ref1-bib158","doi-asserted-by":"publisher","first-page":"192","DOI":"10.1111\/dme.12881","article-title":"Effectiveness of the Kids in Control of Food (KICk\u2013OFF) structured education course for 11\u201316 year olds with type 1 diabetes","volume":"33","author":"Price","year":"2016","journal-title":"Diabet Med"}],"container-title":["Health Technology Assessment"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/publications\/hta22420\/hta22420.xml","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/njl-admin.nihr.ac.uk\/document\/download\/2003409","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/publications\/hta22420\/hta22420.xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/njl-admin.nihr.ac.uk\/document\/download\/2021129","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,15]],"date-time":"2023-08-15T15:47:04Z","timestamp":1692114424000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/hta\/hta22420"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,8]]},"references-count":158,"journal-issue":{"issue":"42","published-online":{"date-parts":[[2018,8]]}},"alternative-id":["10.3310\/hta22420"],"URL":"https:\/\/doi.org\/10.3310\/hta22420","relation":{},"ISSN":["1366-5278","2046-4924"],"issn-type":[{"value":"1366-5278","type":"print"},{"value":"2046-4924","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,8]]},"assertion":[{"value":"This content has been made freely available to all.","name":"free","label":"Free to read"}]}}