{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T17:59:36Z","timestamp":1787680776219,"version":"build-2784847793"},"reference-count":176,"publisher":"National Institute for Health and Care Research","issue":"20","license":[{"start":{"date-parts":[[2017,4,1]],"date-time":"2017-04-01T00:00:00Z","timestamp":1491004800000},"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\/107\/01"],"award-info":[{"award-number":["08\/107\/01"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"Background<\/jats:title>Insulin is generally administered to people with type 1 diabetes mellitus (T1DM) using multiple daily injections (MDIs), but can also be delivered using infusion pumps. In the UK, pumps are recommended for patients with the greatest need and adult use is less than in comparable countries. Previous trials have been small, of short duration and have failed to control for training in insulin adjustment.<\/jats:p><\/jats:sec>Objective<\/jats:title>To assess the clinical effectiveness and cost-effectiveness of pump therapy compared with MDI for adults with T1DM, with both groups receiving equivalent structured training in flexible insulin therapy.<\/jats:p><\/jats:sec>Design<\/jats:title>Pragmatic, multicentre, open-label, parallel-group cluster randomised controlled trial, including economic and psychosocial evaluations. After participants were assigned a group training course, courses were randomly allocated in pairs to either pump or MDI.<\/jats:p><\/jats:sec>Setting<\/jats:title>Eight secondary care diabetes centres in the UK.<\/jats:p><\/jats:sec>Participants<\/jats:title>Adults with T1DM for >\u200912 months, willing to undertake intensive insulin therapy, with no preference for pump or MDI, or a clinical indication for pumps.<\/jats:p><\/jats:sec>Interventions<\/jats:title>Pump or MDI structured training in flexible insulin therapy, followed up for 2 years. MDI participants used insulin analogues. Pump participants used a Medtronic Paradigm\u00ae<\/jats:sup>VeoTM<\/jats:sup>(Medtronic, Watford, UK) with insulin aspart (NovoRapid, Novo Nordisk, Gatwick, UK).<\/jats:p><\/jats:sec>Main outcome measures<\/jats:title>Primary outcome \u2013 change in glycated haemoglobin (HbA1c<\/jats:sub>) at 2 years in participants whose baseline HbA1c<\/jats:sub>was \u2265\u20097.5% (58\u2009mmol\/mol). Key secondary outcome \u2013 proportion of participants with HbA1c<\/jats:sub>\u2264\u20097.5% at 2 years. Other outcomes at 6, 12 and 24 months \u2013 moderate and severe hypoglycaemia; insulin dose; body weight; proteinuria; diabetic ketoacidosis; quality of life (QoL); fear of hypoglycaemia; treatment satisfaction; emotional well-being; qualitative interviews with participants and staff (2 weeks), and participants (6 months); and ICERs in trial and modelled estimates of cost-effectiveness.<\/jats:p><\/jats:sec>Results<\/jats:title>We randomised 46 courses comprising 317 participants: 267 attended a Dose Adjustment For Normal Eating course (132 pump; 135 MDI); 260 were included in the intention-to-treat analysis, of which 235 (119 pump; 116 MDI) had baseline HbA1c<\/jats:sub>of \u2265\u20097.5%. HbA1c<\/jats:sub>and severe hypoglycaemia improved in both groups. The drop in HbA1c<\/jats:sub>% at 2 years was 0.85 on pump and 0.42 on MDI. The mean difference (MD) in HbA1c<\/jats:sub>change at 2 years, at which the baseline HbA1c<\/jats:sub>was \u2265\u20097.5%, was \u20130.24% [95% confidence interval (CI) \u20130.53% to 0.05%] in favour of the pump (p<\/jats:italic>\u2009=\u20090.098). The per-protocol analysis showed a MD in change of \u20130.36% (95% CI \u20130.64% to \u20130.07%) favouring pumps (p<\/jats:italic>\u2009=\u20090.015). Pumps were not cost-effective in the base case and all of the sensitivity analyses. The pump group had greater improvement in diabetes-specific QoL diet restrictions, daily hassle plus treatment satisfaction, statistically significant at 12 and 24 months and supported by qualitative interviews.<\/jats:p><\/jats:sec>Limitation<\/jats:title>Blinding of pump therapy was not possible, although an objective primary outcome was used.<\/jats:p><\/jats:sec>Conclusion<\/jats:title>Adding pump therapy to structured training in flexible insulin therapy did not significantly enhance glycaemic control or psychosocial outcomes in adults with T1DM.<\/jats:p><\/jats:sec>Research priority<\/jats:title>To understand why few patients achieve a HbA1c<\/jats:sub>of <\u20097.5%, particularly as glycaemic control is worse in the UK than in other European countries.<\/jats:p><\/jats:sec>Trial registration<\/jats:title>Current Controlled Trials ISRCTN61215213.<\/jats:p><\/jats:sec>Funding<\/jats:title>This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment<\/jats:italic>; Vol. 21, No. 20. See the NIHR Journals Library website for further project information.<\/jats:p><\/jats:sec>","DOI":"10.3310\/hta21200","type":"journal-article","created":{"date-parts":[[2017,4,25]],"date-time":"2017-04-25T10:02:58Z","timestamp":1493114578000},"page":"1-278","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":46,"title":["A cluster randomised trial, cost-effectiveness analysis and psychosocial evaluation of insulin pump therapy compared with multiple injections during flexible intensive insulin therapy for type 1 diabetes: the REPOSE Trial"],"prefix":"10.3310","volume":"21","clinical-trial-number":[{"clinical-trial-number":"isrctn61215213","registry":"10.18810\/isrctn","type":"results"}],"author":[{"given":"Simon","family":"Heller","sequence":"first","affiliation":[{"name":"Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"White","sequence":"additional","affiliation":[{"name":"Clinical Trials Research Unit, University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ellen","family":"Lee","sequence":"additional","affiliation":[{"name":"Clinical Trials Research Unit, University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Lawton","sequence":"additional","affiliation":[{"name":"Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Pollard","sequence":"additional","affiliation":[{"name":"School of Health and Related Research, University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Norman","family":"Waugh","sequence":"additional","affiliation":[{"name":"Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie","family":"Amiel","sequence":"additional","affiliation":[{"name":"Diabetes Research Group, King\u2019s College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katharine","family":"Barnard","sequence":"additional","affiliation":[{"name":"Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anita","family":"Beckwith","sequence":"additional","affiliation":[{"name":"King\u2019s College Hospital NHS Foundation Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan","family":"Brennan","sequence":"additional","affiliation":[{"name":"School of Health and Related Research, University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Campbell","sequence":"additional","affiliation":[{"name":"School of Health and Related Research, University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cindy","family":"Cooper","sequence":"additional","affiliation":[{"name":"Clinical Trials Research Unit, University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Munyaradzi","family":"Dimairo","sequence":"additional","affiliation":[{"name":"Clinical Trials Research Unit, University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Dixon","sequence":"additional","affiliation":[{"name":"School of Health and Related Research, University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jackie","family":"Elliott","sequence":"additional","affiliation":[{"name":"Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Evans","sequence":"additional","affiliation":[{"name":"Institute of Metabolic Science, University of Cambridge, Cambridge, UK"},{"name":"Wolfson Diabetes Clinic, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fiona","family":"Green","sequence":"additional","affiliation":[{"name":"Dumfries Royal Infirmary NHS Trust, Dumfries, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gemma","family":"Hackney","sequence":"additional","affiliation":[{"name":"Clinical Trials Research Unit, University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Hammond","sequence":"additional","affiliation":[{"name":"Harrogate and District NHS Foundation Trust, Harrogate, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nina","family":"Hallowell","sequence":"additional","affiliation":[{"name":"Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan","family":"Jaap","sequence":"additional","affiliation":[{"name":"Edinburgh Centre for Endocrinology and Diabetes, Royal Infirmary of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Kennon","sequence":"additional","affiliation":[{"name":"Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde, Glasgow, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jackie","family":"Kirkham","sequence":"additional","affiliation":[{"name":"Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Lindsay","sequence":"additional","affiliation":[{"name":"Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Mansell","sequence":"additional","affiliation":[{"name":"Nottingham University Hospitals NHS Trust, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diana","family":"Papaioannou","sequence":"additional","affiliation":[{"name":"Clinical Trials Research Unit, University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Rankin","sequence":"additional","affiliation":[{"name":"Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pamela","family":"Royle","sequence":"additional","affiliation":[{"name":"Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W Henry","family":"Smithson","sequence":"additional","affiliation":[{"name":"Department of General Practice, University College Cork, Cork, Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carolin","family":"Taylor","sequence":"additional","affiliation":[{"name":"Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"6221","published-online":{"date-parts":[[2017,4]]},"reference":[{"key":"key20170419165017245_ref1-bib1","doi-asserted-by":"publisher","first-page":"681","DOI":"10.1007\/BF00296989","article-title":"Evaluation of an intensified insulin treatment and teaching programme as routine management of type 1 (insulin-dependent) diabetes. The Bucharest-D\u00fcsseldorf Study","volume":"30","author":"M\u00fchlhauser","year":"1987","journal-title":"Diabetologia"},{"key":"key20170419165017245_ref1-bib2","doi-asserted-by":"publisher","first-page":"746","DOI":"10.1136\/bmj.325.7367.746","article-title":"Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes: dose adjustment for normal eating (DAFNE) randomised controlled trial","volume":"325","author":"DAFNE Study Group","year":"2002","journal-title":"BMJ"},{"key":"key20170419165017245_ref1-bib3","doi-asserted-by":"publisher","first-page":"1337","DOI":"10.1001\/archinte.165.12.1337","article-title":"Systematic review and meta-analysis of short-acting insulin analogues in patients with diabetes mellitus","volume":"165","author":"Plank","year":"2005","journal-title":"Arch Intern Med"},{"key":"key20170419165017245_ref1-bib4","doi-asserted-by":"publisher","first-page":"CD005613","DOI":"10.1002\/14651858.cd005613.pub3","article-title":"Long-acting insulin analogues versus NPH insulin (human isophane insulin) for type 2 diabetes mellitus","volume":"2","author":"Horvath","year":"2007","journal-title":"Cochrane Database Syst Rev"},{"key":"key20170419165017245_ref1-bib5","doi-asserted-by":"publisher","first-page":"553","DOI":"10.1016\/S2213-8587 (14)70073-7","article-title":"Effect of insulin analogues on risk of severe hypoglycaemia in patients with type 1 diabetes prone to recurrent severe hypoglycaemia (HypoAna trial): a prospective, randomised, open-label, blinded-endpoint crossover trial","volume":"2","author":"Pedersen-Bjergaard","year":"2014","journal-title":"Lancet Diabetes Endocrinol"},{"key":"key20170419165017245_ref1-bib6","doi-asserted-by":"publisher","first-page":"864","DOI":"10.1046\/j.1464-5491.2001.00626.x","article-title":"Recent advances in treatment of youth with type 1 diabetes: better care through technology","volume":"18","author":"Tamborlane","year":"2001","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib7","doi-asserted-by":"publisher","first-page":"593","DOI":"10.2337\/diacare.25.3.593","article-title":"Continuous subcutaneous insulin infusion at 25 years: evidence base for the expanding use of insulin pump therapy in type 1 diabetes","volume":"25","author":"Pickup","year":"2002","journal-title":"Diabetes Care"},{"issue":"17","key":"key20170419165017245_ref1-bib8","doi-asserted-by":"publisher","DOI":"10.3310\/hta20170","article-title":"Type 1 diabetes: integrated sensor-augmented pump therapy systems for managing blood glucose levels (The MiniMed Paradigm Veo System and the Vibe and G4 PLATINUM CGM system), a systematic review and economic evaluation","volume":"20","author":"Riemsma","year":"2016","journal-title":"Health Technol Assess"},{"issue":"11","key":"key20170419165017245_ref1-bib9","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":"key20170419165017245_ref1-bib10","doi-asserted-by":"publisher","first-page":"16","DOI":"10.1111\/j.1742-1241.2010.02574.x","article-title":"Insulin pumps","volume":"170","author":"Pickup","year":"2011","journal-title":"Int J Clin Pract Suppl"},{"key":"key20170419165017245_ref1-bib11","doi-asserted-by":"publisher","first-page":"412","DOI":"10.1111\/dme.12325","article-title":"The U.K. service level audit of insulin pump therapy in adults","volume":"31","author":"White","year":"2014","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib12","doi-asserted-by":"publisher","first-page":"1449","DOI":"10.2337\/dc06-0011","article-title":"Are insulin pumps underutilized in type 1 diabetes? Yes","volume":"29","author":"Pickup","year":"2006","journal-title":"Diabetes Care"},{"key":"key20170419165017245_ref1-bib13","volume-title":"Continuous Subcutaneous Insulin Infusion for the Treatment of Diabetes Mellitus","author":"NICE","year":"2008"},{"issue":"43","key":"key20170419165017245_ref1-bib14","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":"key20170419165017245_ref1-bib15","doi-asserted-by":"publisher","first-page":"778","DOI":"10.1111\/j.1464-5491.2007.02196.x","article-title":"A randomized pilot study in type 1 diabetes complicated by severe hypoglycaemia, comparing rigorous hypoglycaemia avoidance with insulin analogue therapy, CSII or education alone","volume":"24","author":"Thomas","year":"2007","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib16","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":"key20170419165017245_ref1-bib17","doi-asserted-by":"publisher","first-page":"1170","DOI":"10.2337\/dc08-1874","article-title":"Comparison of a multiple daily insulin injection regimen (basal once-daily glargine plus mealtime lispro) and continuous subcutaneous insulin infusion (lispro) in type 1 diabetes: a randomized open parallel multicenter study","volume":"32","author":"Bolli","year":"2009","journal-title":"Diabetes Care"},{"key":"key20170419165017245_ref1-bib18","doi-asserted-by":"publisher","first-page":"S77","DOI":"10.1007\/s00592-009-0132-5","article-title":"Continuous subcutaneous insulin infusion versus multiple daily insulin injections in type 1 diabetes: a meta-analysis","volume":"47","author":"Monami","year":"2010","journal-title":"Acta Diabetol"},{"key":"key20170419165017245_ref1-bib19","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":"key20170419165017245_ref1-bib20","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":"key20170419165017245_ref1-bib21","doi-asserted-by":"publisher","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":"key20170419165017245_ref1-bib22","volume-title":"Guide to the Methods of Technology Appraisal 2013","author":"NICE","year":"2013"},{"key":"key20170419165017245_ref1-bib23","first-page":"j1285","article-title":"Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE)","volume":"356","author":"The REPOSE Study Group","year":"2017","journal-title":"BMJ"},{"key":"key20170419165017245_ref1-bib24","first-page":"7","article-title":"Dose adjustment for normal eating (DAFNE) structured education reduces progression to continuous subcutaneous insulin infusion (CSII) among patients being considered for insulin pump therapy at enrolment","volume":"30","author":"Ray","year":"2013","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib25","doi-asserted-by":"publisher","first-page":"470","DOI":"10.1007\/BF00284453","article-title":"Bicentric evaluation of a teaching and treatment programme for type 1 (insulin-dependent) diabetic patients: improvement of metabolic control and other measures of diabetes care for up to 22 months","volume":"25","author":"M\u00fchlhauser","year":"1983","journal-title":"Diabetologia"},{"key":"key20170419165017245_ref1-bib26","doi-asserted-by":"publisher","first-page":"1965","DOI":"10.1007\/s00125-005-1905-1","article-title":"Glycaemic control and severe hypoglycaemia following training in flexible, intensive insulin therapy to enable dietary freedom in people with type 1 diabetes: a prospective implementation study","volume":"48","author":"S\u00e4mann","year":"2005","journal-title":"Diabetologia"},{"issue":"5","key":"key20170419165017245_ref1-bib27","doi-asserted-by":"publisher","DOI":"10.3310\/pgfar02050","article-title":"Improving management of type 1 diabetes in the UK: the Dose Adjustment For Normal Eating (DAFNE) programme as a research test-bed. A mixed-method analysis of the barriers to and facilitators of successful diabetes self-management, a health economic analysis, a cluster randomised controlled trial of different models of delivery of an educational intervention and the potential of insulin pumps and additional educator input to improve outcomes","volume":"2","author":"Heller","year":"2014","journal-title":"Programme Grants Appl Res"},{"key":"key20170419165017245_ref1-bib28","doi-asserted-by":"publisher","first-page":"705","DOI":"10.1136\/bmj.324.7339.705","article-title":"Glycaemic control with continuous subcutaneous insulin infusion compared with intensive insulin injections in patients with type 1 diabetes: meta-analysis of randomised controlled trials","volume":"324","author":"Pickup","year":"2002","journal-title":"BMJ"},{"key":"key20170419165017245_ref1-bib29","doi-asserted-by":"publisher","first-page":"729","DOI":"10.1210\/jc.2008-1415","article-title":"Clinical review: hypoglycemia with intensive insulin therapy: a systematic review and meta-analyses of randomized trials of continuous subcutaneous insulin infusion versus multiple daily injections","volume":"94","author":"Fatourechi","year":"2009","journal-title":"J Clin Endocrinol Metab"},{"key":"key20170419165017245_ref1-bib30","doi-asserted-by":"publisher","first-page":"941","DOI":"10.1007\/s00125-008-0974-3","article-title":"Continuous subcutaneous insulin infusion versus multiple daily insulin injections in patients with diabetes mellitus: systematic review and meta-analysis","volume":"51","author":"Jeitler","year":"2008","journal-title":"Diabetologia"},{"key":"key20170419165017245_ref1-bib31","doi-asserted-by":"publisher","first-page":"CD005103","DOI":"10.1002\/14651858.CD005103.pub2","article-title":"Continuous subcutaneous insulin infusion (CSII) versus multiple insulin injections for type 1 diabetes mellitus","volume":"1","author":"Misso","year":"2010","journal-title":"Cochrane Database Syst Rev"},{"key":"key20170419165017245_ref1-bib32","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":"key20170419165017245_ref1-bib33","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":"key20170419165017245_ref1-bib34","first-page":"A328","article-title":"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","volume":"48","author":"Maran","year":"2005","journal-title":"Diabetologia"},{"key":"key20170419165017245_ref1-bib35","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":"key20170419165017245_ref1-bib36","doi-asserted-by":"publisher","first-page":"2074","DOI":"10.2337\/diacare.25.11.2074","article-title":"A randomized trial of continuous subcutaneous insulin infusion and intensive injection therapy in type 1 diabetes for patients with long-standing poor glycemic control","volume":"25","author":"DeVries","year":"2002","journal-title":"Diabetes Care"},{"key":"key20170419165017245_ref1-bib37","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":"key20170419165017245_ref1-bib38","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":"key20170419165017245_ref1-bib39","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":"key20170419165017245_ref1-bib40","doi-asserted-by":"publisher","first-page":"533","DOI":"10.2337\/diacare.28.3.533","article-title":"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","volume":"28","author":"Hirsch","year":"2005","journal-title":"Diabetes Care"},{"key":"key20170419165017245_ref1-bib41","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":"key20170419165017245_ref1-bib42","doi-asserted-by":"publisher","first-page":"S144","DOI":"10.1016\/S0168-8227(06)70019-5","article-title":"Comparison between multiple daily insulin injection therapy (MDI) and continuous subcutaneous insulin infusion therapy (CSII), results of the five nations study","volume":"74","author":"Hoogma","year":"2006","journal-title":"Diabetes Res Clin Pract"},{"key":"key20170419165017245_ref1-bib43","doi-asserted-by":"publisher","first-page":"141","DOI":"10.1111\/j.1464-5491.2005.01738.x","article-title":"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","volume":"23","author":"Hoogma","year":"2006","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib44","doi-asserted-by":"publisher","first-page":"1321","DOI":"10.2337\/diacare.26.4.1321","article-title":"Both continuous subcutaneous insulin infusion and a multiple daily insulin injection regimen with glargine as basal insulin are equally better than traditional multiple daily insulin injection treatment","volume":"26","author":"Lepore","year":"2003","journal-title":"Diabetes Care"},{"key":"key20170419165017245_ref1-bib45","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":"key20170419165017245_ref1-bib46","first-page":"289","article-title":"Frequency of hypoglycaemic and hyperglycaemic-ketotic episodes during conventional and subcutaneous continuous insulin infusion therapy in IDDM","volume":"1","author":"Nosadini","year":"1988","journal-title":"Diabetes Nutr Metab Clin Exp"},{"key":"key20170419165017245_ref1-bib47","doi-asserted-by":"publisher","first-page":"1242","DOI":"10.1001\/archopht.1988.01060140402041","article-title":"The response of diabetic retinopathy to 41 months of multiple insulin injections, insulin pumps, and conventional insulin therapy","volume":"106","author":"Brinchmann-Hansen","year":"1988","journal-title":"Arch Ophthalmol"},{"key":"key20170419165017245_ref1-bib48","doi-asserted-by":"publisher","first-page":"1195","DOI":"10.1136\/bmj.293.6556.1195","article-title":"Effect of near normoglycaemia for two years on progression of early diabetic retinopathy, nephropathy, and neuropathy: the Oslo study","volume":"293","author":"Dahl-J\u00f8rgensen","year":"1986","journal-title":"Br Med J"},{"key":"key20170419165017245_ref1-bib49","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":"key20170419165017245_ref1-bib50","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":"key20170419165017245_ref1-bib51","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":"key20170419165017245_ref1-bib52","first-page":"822","article-title":"Comparison of metabolic and psychological parameters during continuous subcutaneous insulin infusion and intensified conventional insulin treatment in type I diabetic patients","volume":"21","author":"Schottenfeld-Naor","year":"1985","journal-title":"Isr J Med Sci"},{"key":"key20170419165017245_ref1-bib53","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":"key20170419165017245_ref1-bib54","doi-asserted-by":"publisher","first-page":"811","DOI":"10.1136\/bmj.290.6471.811","article-title":"Rapid tightening of blood glucose control leads to transient deterioration of retinopathy in insulin dependent diabetes mellitus: the Oslo study","volume":"290","author":"Dahl-J\u00f8rgensen","year":"1985","journal-title":"Br Med J"},{"key":"key20170419165017245_ref1-bib55","first-page":"S450","article-title":"The effectiveness and safety of continuous subcutaneous insulin infusion in a large adult cohort over a 10 year period","volume":"1","author":"Bacon","year":"2014","journal-title":"Ir J Med Sci"},{"key":"key20170419165017245_ref1-bib56","doi-asserted-by":"publisher","first-page":"1453","DOI":"10.1111\/dme.12869","article-title":"Sustained benefit of continuous subcutaneous insulin infusion on glycaemic control and hypoglycaemia in adults with type 1 diabetes","volume":"32","author":"Beato-V\u00edbora","year":"2015","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib57","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":"key20170419165017245_ref1-bib58","doi-asserted-by":"publisher","first-page":"302","DOI":"10.1089\/dia.2012.0286","article-title":"Insulin pump-long-term effects on glycemic control: an observational study at 10 diabetes clinics in Sweden","volume":"15","author":"Carlsson","year":"2013","journal-title":"Diabetes Technol Ther"},{"key":"key20170419165017245_ref1-bib59","doi-asserted-by":"publisher","first-page":"21","DOI":"10.1089\/dia.2014.0139","article-title":"Predicting the effectiveness of insulin pump therapy on glycemic control in clinical practice: a retrospective study of patients with type 1 diabetes from 10 outpatient diabetes clinics in Sweden over 5 years","volume":"17","author":"Clements","year":"2015","journal-title":"Diabetes Technol Ther"},{"key":"key20170419165017245_ref1-bib60","doi-asserted-by":"publisher","first-page":"544","DOI":"10.1089\/dia.2012.0331","article-title":"Long-term metabolic effects of continuous subcutaneous insulin infusion therapy in type 1 diabetes","volume":"15","author":"Cohen","year":"2013","journal-title":"Diabetes Technol Ther"},{"key":"key20170419165017245_ref1-bib61","doi-asserted-by":"publisher","first-page":"602","DOI":"10.1111\/j.1464-5491.2009.02736.x","article-title":"Continuous subcutaneous insulin infusion is more effective than multiple daily insulin injections in preventing albumin excretion rate increase in type 1 diabetic patients","volume":"26","author":"Lepore","year":"2009","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib62","doi-asserted-by":"publisher","first-page":"1174","DOI":"10.1111\/dme.12486","article-title":"Variations in the quality and sustainability of long-term glycaemic control with continuous subcutaneous insulin infusion","volume":"31","author":"Nixon","year":"2014","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib63","doi-asserted-by":"publisher","first-page":"49","DOI":"10.1089\/dia.2014.0131","article-title":"Long-term efficacy of insulin pump therapy on glycemic control in adults with type 1 diabetes mellitus","volume":"17","author":"Orr","year":"2015","journal-title":"Diabetes Technol Ther"},{"key":"key20170419165017245_ref1-bib64","doi-asserted-by":"publisher","first-page":"1422","DOI":"10.1111\/dme.13094","article-title":"Long-term outcome of insulin pump therapy: reduction of hypoglycaemia and impact on glycaemic control","volume":"33","author":"Quiros","year":"2016","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib65","doi-asserted-by":"publisher","first-page":"1445","DOI":"10.1111\/dme.12950","article-title":"Effect of 4 years subcutaneous insulin infusion treatment on albuminuria, kidney function and HbA1c compared with multiple daily injections: a longitudinal follow-up study","volume":"32","author":"Rosenlund","year":"2015","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib66","doi-asserted-by":"publisher","first-page":"h3234","DOI":"10.1136\/bmj.h3234","article-title":"Insulin pump therapy, multiple daily injections, and cardiovascular mortality in 18,168 people with type 1 diabetes: observational study","volume":"350","author":"Steineck","year":"2015","journal-title":"BMJ"},{"key":"key20170419165017245_ref1-bib67","first-page":"S33","article-title":"Effectiveness of therapeutic-educational re-training in patients affected by type 1 diabetes treated with CSII (continuous subcutaneous insulin infusion)","volume":"54","author":"Carlone","year":"2011","journal-title":"Diabetologia"},{"key":"key20170419165017245_ref1-bib68","doi-asserted-by":"publisher","first-page":"1158","DOI":"10.1111\/j.1464-5491.2011.03256.x","article-title":"Sensor-augmented pump therapy lowers HbA(1c) in suboptimally controlled type 1 diabetes; a randomized controlled trial","volume":"28","author":"Hermanides","year":"2011","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib69","doi-asserted-by":"publisher","first-page":"400","DOI":"10.1177\/193229680700100313","article-title":"Combined insulin pump therapy with real-time continuous glucose monitoring significantly improves glycemic control compared to multiple daily injection therapy in pump na\u00efve patients with type 1 diabetes; single center pilot study experience","volume":"1","author":"Lee","year":"2007","journal-title":"J Diabetes Sci Technol"},{"key":"key20170419165017245_ref1-bib70","doi-asserted-by":"publisher","first-page":"57","DOI":"10.1089\/dia.2008.0002","article-title":"Patient-reported outcomes for an integrated real-time continuous glucose monitoring\/insulin pump system","volume":"11","author":"Peyrot","year":"2009","journal-title":"Diabetes Technol Ther"},{"key":"key20170419165017245_ref1-bib71","doi-asserted-by":"publisher","first-page":"311","DOI":"10.1056\/NEJMoa1002853","article-title":"Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes","volume":"363","author":"Bergenstal","year":"2010","journal-title":"N Engl J Med"},{"key":"key20170419165017245_ref1-bib72","doi-asserted-by":"publisher","first-page":"574","DOI":"10.2337\/dc10-1852","article-title":"Use of continuous glucose monitoring in subjects with type 1 diabetes on multiple daily injections versus continuous subcutaneous insulin infusion therapy: a prospective 6-month study","volume":"34","author":"Garg","year":"2011","journal-title":"Diabetes Care"},{"key":"key20170419165017245_ref1-bib73","doi-asserted-by":"publisher","first-page":"2023","DOI":"10.2337\/dc10-2411","article-title":"Insulin pump therapy with automated insulin suspension in response to hypoglycemia: reduction in nocturnal hypoglycemia in those at greatest risk","volume":"34","author":"Choudhary","year":"2011","journal-title":"Diabetes Care"},{"key":"key20170419165017245_ref1-bib74","doi-asserted-by":"publisher","first-page":"224","DOI":"10.1056\/NEJMoa1303576","article-title":"Threshold-based insulin-pump interruption for reduction of hypoglycemia","volume":"369","author":"Bergenstal","year":"2013","journal-title":"N Engl J Med"},{"key":"key20170419165017245_ref1-bib75","doi-asserted-by":"publisher","first-page":"1240","DOI":"10.1001\/jama.2013.277818","article-title":"Effect of sensor-augmented insulin pump therapy and automated insulin suspension vs. standard insulin pump therapy on hypoglycemia in patients with type 1 diabetes: a randomized clinical trial","volume":"310","author":"Ly","year":"2013","journal-title":"JAMA"},{"key":"key20170419165017245_ref1-bib76","doi-asserted-by":"publisher","first-page":"185","DOI":"10.1177\/1932296815597918","article-title":"IQWiG Reanalyzes and raises questions about an article by Ly et al. which concluded low glucose suspend is very beneficial","volume":"10","author":"Heinemann","year":"2016","journal-title":"J Diabetes Sci Technol"},{"key":"key20170419165017245_ref1-bib77","volume-title":"Integrated sensor-dugmented pump therapy systems for managing blood glucose levels in type 1 diabetes (the MiniMed Paradigm Veo system and the Vibe and G4 PLATINUM CGM system)","author":"NICE","year":"2016"},{"key":"key20170419165017245_ref1-bib78","doi-asserted-by":"publisher","first-page":"391","DOI":"10.1111\/dme.12621","article-title":"A cluster randomized controlled non-inferiority trial of 5-day Dose Adjustment for Normal Eating (DAFNE) training delivered over 1\u2009week versus 5-day DAFNE training delivered over 5\u2009weeks: the DAFNE 5\u2009\u00d7\u20091-day trial","volume":"32","author":"Elliott","year":"2015","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib79","first-page":"S444","article-title":"Outcomes in people with type 1 diabetes transferring to insulin pump therapy after structured education","volume":"56","author":"Mansell","year":"2013","journal-title":"Diabetologia"},{"key":"key20170419165017245_ref1-bib80","first-page":"177","article-title":"Higher levels of psychological distress in people with type 1 diabetes who transfer to insulin pump therapy after Dose Adjustment for Normal Eating (DAFNE) structured education","volume":"30","author":"Cole","year":"2013","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib81","doi-asserted-by":"publisher","first-page":"29","DOI":"10.1016\/j.diabres.2013.01.017","article-title":"Group follow-up compared to individual clinic visits after structured education for type 1 diabetes: a cluster randomised controlled trial","volume":"100","author":"Dinneen","year":"2013","journal-title":"Diabetes Res Clin Pract"},{"key":"key20170419165017245_ref1-bib82","doi-asserted-by":"publisher","first-page":"672","DOI":"10.1186\/1471-2458-11-672","article-title":"A longitudinal qualitative study examining the factors impacting on the ability of persons with T1DM to assimilate the Dose Adjustment for Normal Eating (DAFNE) principles into daily living and how these factors change over time","volume":"11","author":"Casey","year":"2011","journal-title":"BMC Public Health"},{"key":"key20170419165017245_ref1-bib83","doi-asserted-by":"publisher","first-page":"271","DOI":"10.1016\/j.diabres.2010.11.023","article-title":"Impact of dose adjustment for normal eating in Australia (OzDAFNE) on subjective wellbeing, coping resources and negative affects in adults with type 1 diabetes: a prospective comparison study","volume":"91","author":"Engel","year":"2011","journal-title":"Diabetes Res Clin Pract"},{"key":"key20170419165017245_ref1-bib84","first-page":"S452","article-title":"Faster-acting insulin aspart by continuous subcutaneous insulin infusion: earlier exposure and greater early pharmacokinetic\/pharmacodynamic effects vs. insulin aspart","volume":"1","author":"Zijlstra","year":"2015","journal-title":"Diabetologia"},{"key":"key20170419165017245_ref1-bib85","doi-asserted-by":"publisher","first-page":"213","DOI":"10.1111\/j.1464-5491.2007.02346.x","article-title":"Quality of life and treatment satisfaction in adults with type 1 diabetes: a comparison between continuous subcutaneous insulin infusion and multiple daily injections","volume":"25","author":"EQuality1 Study Group","year":"2008","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib86","doi-asserted-by":"publisher","first-page":"e006204","DOI":"10.1136\/bmjopen-2014-006204","article-title":"The Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE): study protocol for a cluster randomised controlled trial","volume":"4","author":"White","year":"2014","journal-title":"BMJ Open"},{"key":"key20170419165017245_ref1-bib87","doi-asserted-by":"publisher","first-page":"863","DOI":"10.1046\/j.1464-5491.2003.01018.x","article-title":"Are analogue insulins better than soluble in continuous subcutaneous insulin infusion? Results of a meta-analysis","volume":"20","author":"Colquitt","year":"2003","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib88","doi-asserted-by":"publisher","first-page":"569","DOI":"10.1007\/s40273-015-0374-8","article-title":"A systematic review of cost-effectiveness models in type 1 diabetes mellitus","volume":"34","author":"Henriksson","year":"2016","journal-title":"PharmacoEconomics"},{"key":"key20170419165017245_ref1-bib89","doi-asserted-by":"publisher","first-page":"1140","DOI":"10.1007\/s00125-007-0599-y","article-title":"Risk of hypoglycaemia in types 1 and 2 diabetes: effects of treatment modalities and their duration","volume":"50","author":"UK Hypoglycaemia Study Group","year":"2007","journal-title":"Diabetologia"},{"key":"key20170419165017245_ref1-bib90","doi-asserted-by":"publisher","first-page":"1384","DOI":"10.2337\/dc12-2480","article-title":"Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society","volume":"36","author":"Seaquist","year":"2013","journal-title":"Diabetes Care"},{"key":"key20170419165017245_ref1-bib91","doi-asserted-by":"publisher","first-page":"232","DOI":"10.1002\/dmrr.377","article-title":"Recall of severe hypoglycaemia and self-estimated state of awareness in type 1 diabetes","volume":"19","author":"Pedersen-Bjergaard","year":"2003","journal-title":"Diabetes Metab Res Rev"},{"key":"key20170419165017245_ref1-bib92","volume-title":"The Medicines for Human Use (Clinical Trials) Regulations 2004","author":"Statutory Instruments","year":"2004"},{"key":"key20170419165017245_ref1-bib93","volume-title":"Risk-adapted Approaches to the Management of Clinical Trials of Investigational Medicinal Products","author":"Medical Research Council\/DH\/MHRA Joint Project","year":"2011"},{"key":"key20170419165017245_ref1-bib94","doi-asserted-by":"publisher","first-page":"585","DOI":"10.1177\/1740774509347398","article-title":"Risk analysis and risk adapted on-site monitoring in noncommercial clinical trials","volume":"6","author":"Brosteanu","year":"2009","journal-title":"Clin Trials"},{"issue":"33","key":"key20170419165017245_ref1-bib95","doi-asserted-by":"publisher","DOI":"10.3310\/hta5330","article-title":"Subgroup analyses in randomised controlled trials: quantifying the risks of false-positives and false-negatives","volume":"5","author":"Brookes","year":"2001","journal-title":"Health Technol Assess"},{"key":"key20170419165017245_ref1-bib96","volume-title":"Unit Costs of Health and Social Care 2014","author":"Curtis","year":"2014"},{"key":"key20170419165017245_ref1-bib97","volume-title":"DAFNE Fact Sheet Six","author":"DAFNE","year":"2012"},{"key":"key20170419165017245_ref1-bib98","volume-title":"NHS Reference Costs 2013 to 2014","author":"Department of Health","year":"2014"},{"key":"key20170419165017245_ref1-bib99","doi-asserted-by":"publisher","first-page":"847","DOI":"10.1111\/dme.12441","article-title":"Substantial reductions in the number of diabetic ketoacidosis and severe hypoglycaemia episodes requiring emergency treatment lead to reduced costs after structured education in adults with type 1 diabetes","volume":"31","author":"Elliott","year":"2014","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib100","volume-title":"NHS Reference Costs 2012 to 2013","author":"Department of Health","year":"2013"},{"key":"key20170419165017245_ref1-bib101","volume-title":"British National Formulary (online)","author":"Joint Formulary Committee"},{"key":"key20170419165017245_ref1-bib102","volume-title":"Prescription Cost Analysis England 2014","author":"Health and Social Care Information Centre","year":"2015"},{"key":"key20170419165017245_ref1-bib103","volume-title":"Comparative Table of Insulin Pumps","author":"London New Drugs Group","year":"2013"},{"key":"key20170419165017245_ref1-bib104","doi-asserted-by":"publisher","first-page":"851","DOI":"10.1097\/01.mlr.0000135827.18610.0d","article-title":"The estimation of a preference-based measure of health from the SF-12","volume":"42","author":"Brazier","year":"2004","journal-title":"Med Care"},{"key":"key20170419165017245_ref1-bib105","doi-asserted-by":"publisher","first-page":"348","DOI":"10.1080\/01621459.1962.10480664","article-title":"An efficient method of estimating seemingly unrelated regressions and tests for aggregation bias","volume":"57","author":"Zellner","year":"1962","journal-title":"J Am Stat Assoc"},{"key":"key20170419165017245_ref1-bib106","doi-asserted-by":"publisher","first-page":"487","DOI":"10.1002\/hec.944","article-title":"Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility","volume":"14","author":"Manca","year":"2005","journal-title":"Health Econ"},{"key":"key20170419165017245_ref1-bib107","doi-asserted-by":"publisher","DOI":"10.1002\/9780470316696","volume-title":"Multiple Imputation for Nonresponse in Surveys","author":"Rubin","year":"1987"},{"key":"key20170419165017245_ref1-bib108","doi-asserted-by":"publisher","first-page":"477","DOI":"10.1111\/dme.12371","article-title":"Assessing the cost-effectiveness of type 1 diabetes interventions: the Sheffield type 1 diabetes policy model","volume":"31","author":"Thokala","year":"2014","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib109","doi-asserted-by":"publisher","first-page":"1213","DOI":"10.1111\/j.1464-5491.2011.03342.x","article-title":"A new model for 5-year risk of cardiovascular disease in type1 diabetes; from the Swedish National Diabetes Register (NDR)","volume":"28","author":"Cederholm","year":"2011","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib110","unstructured":"Palmer JL. Cost-effectiveness of Angiotensin-converting Enzyme Inhibitors for the Prevention of Cardiovascular and End-stage Renal Disease in Patients with Type 1 Diabetes. 2012. PhD thesis. Sheffield: University of Sheffield; 2012."},{"key":"key20170419165017245_ref1-bib111","doi-asserted-by":"publisher","first-page":"2643","DOI":"10.1056\/NEJMoa052187","article-title":"Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes","volume":"353","author":"Nathan","year":"2005","journal-title":"N Engl J Med"},{"key":"key20170419165017245_ref1-bib112","doi-asserted-by":"publisher","first-page":"1020","DOI":"10.1177\/0272989X16658660","article-title":"The impact of diabetes-related complications on preference-based measures of health-related quality of life in adults with type I diabetes","volume":"36","author":"Peasgood","year":"2016","journal-title":"Med Decis Mak"},{"key":"key20170419165017245_ref1-bib113","doi-asserted-by":"publisher","first-page":"462","DOI":"10.1016\/j.jval.2014.03.003","article-title":"Review of utility values for economic modeling in type 2 diabetes","volume":"17","author":"Beaudet","year":"2014","journal-title":"Value Health"},{"key":"key20170419165017245_ref1-bib114","doi-asserted-by":"publisher","first-page":"2238","DOI":"10.2337\/diacare.25.12.2238","article-title":"Valuing health-related quality of life in diabetes","volume":"25","author":"Coffey","year":"2002","journal-title":"Diabetes Care"},{"key":"key20170419165017245_ref1-bib115","doi-asserted-by":"publisher","first-page":"487","DOI":"10.1002\/hec.2930","article-title":"The effect of diabetes complications on health-related quality of life: the importance of longitudinal data to address patient heterogeneity","volume":"23","author":"Alva","year":"2014","journal-title":"Health Econ"},{"key":"key20170419165017245_ref1-bib116","doi-asserted-by":"publisher","first-page":"340","DOI":"10.1177\/027298902400448902","article-title":"Estimating utility values for health states of type 2 diabetic patients using the EQ-5D (UKPDS 62)","volume":"22","author":"Clarke","year":"2002","journal-title":"Med Decis Making"},{"key":"key20170419165017245_ref1-bib117","volume-title":"British National Formulary","author":"Joint Formulary Committee","year":"2012","edition":"63 ed."},{"key":"key20170419165017245_ref1-bib118","doi-asserted-by":"publisher","first-page":"S7","DOI":"10.1185\/030079907X167561","article-title":"Evaluation of the cost-effectiveness of insulin glargine versus NPH insulin for the treatment of type 1 diabetes in the UK","volume":"23","author":"McEwan","year":"2007","journal-title":"Curr Med Res Opin"},{"key":"key20170419165017245_ref1-bib119","author":"Department of Health","year":"2011","journal-title":"NHS Reference Costs 2010\u201311"},{"key":"key20170419165017245_ref1-bib120","doi-asserted-by":"publisher","first-page":"187","DOI":"10.1111\/j.1464-5491.2006.02057.x","article-title":"The financial costs of healthcare treatment for people with type 1 or type 2 diabetes in the UK with particular reference to differing severity of peripheral neuropathy","volume":"24","author":"Currie","year":"2007","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib121","doi-asserted-by":"publisher","first-page":"442","DOI":"10.1046\/j.1464-5491.2003.00972.x","article-title":"The impact of diabetes-related complications on healthcare costs: results from the United Kingdom Prospective Diabetes Study (UKPDS Study No. 65)","volume":"20","author":"Clarke","year":"2003","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib122","doi-asserted-by":"crossref","first-page":"499","DOI":"10.1093\/clinchem\/18.6.499","article-title":"Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge","volume":"18","author":"Friedewald","year":"1972","journal-title":"Clin Chem"},{"key":"key20170419165017245_ref1-bib123","doi-asserted-by":"publisher","first-page":"1","DOI":"10.18637\/jss.v034.i02","article-title":"Beta regression in R","volume":"34","author":"Cribari-Neto","year":"2010","journal-title":"J Stat Softw"},{"key":"key20170419165017245_ref1-bib124","doi-asserted-by":"publisher","first-page":"22","DOI":"10.1016\/j.diabres.2010.03.017","article-title":"Long-term biomedical and psychosocial outcomes following DAFNE (Dose Adjustment For Normal Eating) structured education to promote intensive insulin therapy in adults with sub-optimally controlled type 1 diabetes","volume":"89","author":"Speight","year":"2010","journal-title":"Diabetes Res Clin Pract"},{"key":"key20170419165017245_ref1-bib125","doi-asserted-by":"publisher","first-page":"807","DOI":"10.1111\/j.1464-5491.2011.03525.x","article-title":"Glycaemic control and weight 7 years after Dose Adjustment For Normal Eating (DAFNE) structured education in type 1 diabetes","volume":"29","author":"Gunn","year":"2012","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib126","first-page":"405","article-title":"Patient-reported outcomes and diabetes technology: a systematic review of the literature","volume":"7","author":"Rubin","year":"2010","journal-title":"Pediatr Endocrinol Rev"},{"key":"key20170419165017245_ref1-bib127","doi-asserted-by":"publisher","first-page":"757","DOI":"10.2337\/diacare.21.5.757","article-title":"Validation of a diabetes-specific quality-of-life scale for patients with type 1 diabetes","volume":"21","author":"Bott","year":"1998","journal-title":"Diabetes Care"},{"key":"key20170419165017245_ref1-bib128","doi-asserted-by":"publisher","first-page":"551","DOI":"10.1017\/S0033291798006667","article-title":"Development of the World Health Organisation WHOQOL-BREF quality of life assessment","volume":"28","author":"The WHOQOL Group","year":"1998","journal-title":"Psychol Med"},{"key":"key20170419165017245_ref1-bib129","doi-asserted-by":"publisher","first-page":"220","DOI":"10.1097\/00005650-199603000-00003","article-title":"A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity","volume":"34","author":"Ware","year":"1996","journal-title":"Med Care"},{"key":"key20170419165017245_ref1-bib130","doi-asserted-by":"publisher","first-page":"199","DOI":"10.1016\/0168-8510(90)90421-9","article-title":"EuroQol: a new facility for the measurement of health-related quality of life","volume":"16","author":"The EuroQol Group","year":"1990","journal-title":"Health Policy (New York)"},{"key":"key20170419165017245_ref1-bib131","doi-asserted-by":"publisher","first-page":"617","DOI":"10.2337\/diacare.10.5.617","article-title":"Fear of hypoglycemia: quantification, validation, and utilization","volume":"10","author":"Cox","year":"1987","journal-title":"Diabetes Care"},{"key":"key20170419165017245_ref1-bib132","doi-asserted-by":"publisher","first-page":"93","DOI":"10.1089\/dia.2010.0192","article-title":"Fear of hypoglycemia in type 1 diabetes managed by continuous subcutaneous insulin infusion: is it associated with poor glycemic control?","volume":"13","author":"Nixon","year":"2011","journal-title":"Diabetes Technol Ther"},{"key":"key20170419165017245_ref1-bib133","doi-asserted-by":"publisher","first-page":"235","DOI":"10.1111\/j.1464-5491.1988.tb00976.x","article-title":"A measure of treatment satisfaction designed specifically for people with insulin-dependent diabetes","volume":"5","author":"Lewis","year":"1988","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib134","doi-asserted-by":"publisher","first-page":"80","DOI":"10.1186\/1477-7525-4-80","article-title":"Patient-reported outcomes in a trial of exenatide and insulin glargine for the treatment of type 2 diabetes","volume":"4","author":"Secnik Boye","year":"2006","journal-title":"Health Qual Life Outcomes"},{"key":"key20170419165017245_ref1-bib135","doi-asserted-by":"publisher","first-page":"361","DOI":"10.1111\/j.1600-0447.1983.tb09716.x","article-title":"The Hospital Anxiety and Depression Scale","volume":"67","author":"Zigmond","year":"1983","journal-title":"Acta Psychiatr Scand"},{"key":"key20170419165017245_ref1-bib136","doi-asserted-by":"publisher","first-page":"142","DOI":"10.1016\/j.jclinepi.2004.06.005","article-title":"A simple imputation algorithm reduced missing data in SF-12 health surveys","volume":"58","author":"Perneger","year":"2005","journal-title":"J Clin Epidemiol"},{"key":"key20170419165017245_ref1-bib137","doi-asserted-by":"publisher","first-page":"1171","DOI":"10.1016\/S0895-4356(98)00109-7","article-title":"Cross-validation of item selection and scoring for the SF-12 Health Survey in nine countries: results from the IQOLA Project. International Quality of Life Assessment","volume":"51","author":"Gandek","year":"1998","journal-title":"J Clin Epidemiol"},{"key":"key20170419165017245_ref1-bib138","volume-title":"WHOQOL-Bref: Introduction, Administration, Scoring and Generic Version of the Assessment","author":"The WHOQOL Group","year":"1996"},{"key":"key20170419165017245_ref1-bib139","doi-asserted-by":"crossref","first-page":"497","DOI":"10.1177\/1536867X0600600404","article-title":"Confidence intervals for rank statistics: percentile slopes, differences, and ratios","volume":"6","author":"Newson","year":"2006","journal-title":"Stata J"},{"key":"key20170419165017245_ref1-bib140","volume-title":"The Discovery of Grounded Theory: Strategies for Qualitative Research","author":"Glaser","year":"1967"},{"key":"key20170419165017245_ref1-bib141","doi-asserted-by":"publisher","first-page":"251","DOI":"10.1136\/bmj.311.6999.251","article-title":"Qualitative interviews in medical research","volume":"311","author":"Britten","year":"1995","journal-title":"BMJ"},{"key":"key20170419165017245_ref1-bib142","doi-asserted-by":"publisher","first-page":"42","DOI":"10.1136\/bmj.311.6996.42","article-title":"Reaching the parts other methods cannot reach: an introduction to qualitative methods in health and health services research","volume":"311","author":"Pope","year":"1995","journal-title":"BMJ"},{"key":"key20170419165017245_ref1-bib143","doi-asserted-by":"publisher","first-page":"236","DOI":"10.1016\/j.diabres.2012.09.024","article-title":"Patients\u2019 experiences of adjusting insulin doses when implementing flexible intensive insulin therapy: a longitudinal, qualitative investigation","volume":"98","author":"Lawton","year":"2012","journal-title":"Diabetes Res Clin Pract"},{"key":"key20170419165017245_ref1-bib144","doi-asserted-by":"publisher","first-page":"652","DOI":"10.1186\/1471-2458-12-652","article-title":"Supporting self-management after attending a structured education programme: a qualitative longitudinal investigation of type 1 diabetes patients\u2019 experiences and views","volume":"12","author":"Rankin","year":"2012","journal-title":"BMC Public Health"},{"key":"key20170419165017245_ref1-bib145","doi-asserted-by":"publisher","first-page":"209","DOI":"10.1111\/dme.12007","article-title":"Self-treating hypoglycaemia: a longitudinal qualitative investigation of the experiences and views of people with type 1 diabetes","volume":"30","author":"Lawton","year":"2013","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib146","doi-asserted-by":"publisher","first-page":"87","DOI":"10.1016\/j.diabres.2010.11.007","article-title":"Dose Adjustment for Normal Eating: a qualitative longitudinal exploration of the food and eating practices of type 1 diabetes patients converted to flexible intensive insulin therapy in the UK","volume":"91","author":"Lawton","year":"2011","journal-title":"Diabetes Res Clin Pract"},{"key":"key20170419165017245_ref1-bib147","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1186\/1745-6215-16-3","article-title":"Uncovering the emotional aspects of working on a clinical trial: a qualitative study of the experiences and views of staff involved in a type 1 diabetes trial","volume":"16","author":"Lawton","year":"2015","journal-title":"Trials"},{"key":"key20170419165017245_ref1-bib148","volume-title":"Basics of Qualitative Research: Grounded Theory Procedures and Techniques","author":"Strauss","year":"1990"},{"key":"key20170419165017245_ref1-bib149","volume-title":"Standard occupational classification 2010","author":"Office for National Statistics","year":"2010"},{"key":"key20170419165017245_ref1-bib150","volume-title":"English indices of deprivation 2010","author":"Department for Communities and Local Government","year":"2011"},{"key":"key20170419165017245_ref1-bib151","volume-title":"Scottish Index of Multiple Deprivation 2012","author":"Scottish Government","year":"2012"},{"key":"key20170419165017245_ref1-bib152","doi-asserted-by":"publisher","first-page":"309","DOI":"10.1002\/hec.4730030505","article-title":"Costs, effects and C\/E-ratios alongside a clinical trial","volume":"3","author":"Van Hout","year":"1994","journal-title":"Health Econ"},{"key":"key20170419165017245_ref1-bib153","doi-asserted-by":"publisher","first-page":"270","DOI":"10.2337\/dc12-0080","article-title":"Structured type 1 diabetes education delivered within routine care: impact on glycemic control and diabetes-specific quality of life","volume":"36","author":"Cooke","year":"2013","journal-title":"Diabetes Care"},{"key":"key20170419165017245_ref1-bib154","doi-asserted-by":"publisher","first-page":"2919","DOI":"10.1111\/jocn.12539","article-title":"Type 1 diabetes patients\u2019 experiences of, and need for, social support after attending a structured education programme: a qualitative longitudinal investigation","volume":"23","author":"Rankin","year":"2014","journal-title":"J Clin Nurs"},{"key":"key20170419165017245_ref1-bib155","doi-asserted-by":"publisher","first-page":"443","DOI":"10.1016\/j.diabres.2014.09.011","article-title":"Perceptions and experiences of using automated bolus advisors amongst people with type 1 diabetes: a longitudinal qualitative investigation","volume":"106","author":"Lawton","year":"2014","journal-title":"Diabetes Res Clin Pract"},{"key":"key20170419165017245_ref1-bib156","doi-asserted-by":"publisher","first-page":"54","DOI":"10.1016\/j.pedn.2014.09.006","article-title":"The experience of living with type 1 diabetes and attending clinic from the perception of children, adolescents and carers: analysis of qualitative data from the DEPICTED study","volume":"30","author":"Lowes","year":"2015","journal-title":"J Pediatr Nurs"},{"key":"key20170419165017245_ref1-bib157","doi-asserted-by":"publisher","first-page":"243","DOI":"10.1111\/dme.12879","article-title":"Who gains clinical benefit from using insulin pump therapy? A qualitative study of the perceptions and views of health professionals involved in the Relative Effectiveness of Pumps over MDI and Structured Education (REPOSE) trial","volume":"33","author":"Lawton","year":"2016","journal-title":"Diabet Med"},{"key":"key20170419165017245_ref1-bib158","doi-asserted-by":"publisher","first-page":"12","DOI":"10.1002\/edn.167","article-title":"A hermeneutic phenomenological study of why adults with type 1 diabetes choose to discontinue CSII","volume":"8","author":"Hayes","year":"2011","journal-title":"Eur Diabetes Nurs"},{"key":"key20170419165017245_ref1-bib159","volume-title":"Type 1 Diabetes in Adults: Diagnosis and Management","author":"NICE"},{"key":"key20170419165017245_ref1-bib160","volume-title":"National Diabetes Audit 2012\u201313. Report 1: Care Processes and Treatment Targets","author":"Health and Social Care Information Centre","year":"2014"},{"key":"key20170419165017245_ref1-bib161","doi-asserted-by":"publisher","first-page":"e002889","DOI":"10.1136\/bmjopen-2013-002889","article-title":"What can qualitative research do for randomised controlled trials? A systematic mapping review","volume":"3","author":"O\u2019Cathain","year":"2013","journal-title":"BMJ Open"},{"key":"key20170419165017245_ref1-bib162","doi-asserted-by":"publisher","first-page":"338","DOI":"10.1016\/j.cct.2014.06.002","article-title":"Conducting qualitative research within clinical trials units: avoiding potential pitfalls","volume":"38","author":"Cooper","year":"2014","journal-title":"Contemp Clin Trials"},{"key":"key20170419165017245_ref1-bib163","doi-asserted-by":"publisher","first-page":"766","DOI":"10.1136\/bmj.325.7367.766","article-title":"Quality improvement report: Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: presenting unbiased information to patients can be difficult","volume":"325","author":"Donovan","year":"2002","journal-title":"BMJ"},{"key":"key20170419165017245_ref1-bib164","doi-asserted-by":"publisher","first-page":"5","DOI":"10.1186\/1745-6215-15-5","article-title":"Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials","volume":"15","author":"Donovan","year":"2014","journal-title":"Trials"},{"key":"key20170419165017245_ref1-bib165","doi-asserted-by":"publisher","first-page":"912","DOI":"10.1016\/j.jclinepi.2014.03.010","article-title":"The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials","volume":"67","author":"Donovan","year":"2014","journal-title":"J Clin Epidemiol"},{"key":"key20170419165017245_ref1-bib166","doi-asserted-by":"publisher","first-page":"15","DOI":"10.1186\/1745-6215-15-15","article-title":"The face of equipoise: delivering a structured education programme within a randomized controlled trial: qualitative study","volume":"15","author":"Eborall","year":"2014","journal-title":"Trials"},{"key":"key20170419165017245_ref1-bib167","doi-asserted-by":"publisher","first-page":"709","DOI":"10.1016\/S0277-9536(01)00197-6","article-title":"\u2018Why don\u2019t they just tell me straight, why allocate it?\u2019 The struggle to make sense of participating in a randomised controlled trial","volume":"55","author":"Featherstone","year":"2002","journal-title":"Soc Sci Med"},{"key":"key20170419165017245_ref1-bib168","first-page":"41","article-title":"What we learnt: recruiting prenatal mothers to an RCT addressing the prevention of overweight in early childhood?","volume":"28","author":"Wardle","year":"2010","journal-title":"Aust J Adv Nurs"},{"key":"key20170419165017245_ref1-bib169","doi-asserted-by":"publisher","first-page":"574","DOI":"10.1016\/j.socscimed.2011.11.012","article-title":"Understanding the outcomes of multi-centre clinical trials: a qualitative study of health professional experiences and views","volume":"74","author":"Lawton","year":"2012","journal-title":"Soc Sci Med"},{"key":"key20170419165017245_ref1-bib170","doi-asserted-by":"publisher","first-page":"108","DOI":"10.1186\/1745-6215-12-108","article-title":"Challenges of maintaining research protocol fidelity in a clinical care setting: a qualitative study of the experiences and views of patients and staff participating in a randomized controlled trial","volume":"12","author":"Lawton","year":"2011","journal-title":"Trials"},{"key":"key20170419165017245_ref1-bib171","first-page":"394","article-title":"Participating in the United Kingdom Prospective Diabetes Study (UKPDS): a qualitative study of patients\u2019 experiences","volume":"53","author":"Lawton","year":"2003","journal-title":"Br J Gen Pract"},{"key":"key20170419165017245_ref1-bib172","doi-asserted-by":"publisher","first-page":"1289","DOI":"10.1016\/0277-9536(89)90069-5","article-title":"Is it any good? The evaluation of therapy by participants in a clinical trial","volume":"29","author":"Wynne","year":"1989","journal-title":"Soc Sci Med"},{"key":"key20170419165017245_ref1-bib173","doi-asserted-by":"publisher","first-page":"61","DOI":"10.1186\/s13063-017-1813-y","article-title":"Staff experiences of closing out a clinical trial involving withdrawal of treatment: qualitative study","volume":"18","author":"Lawton","year":"2017","journal-title":"Trials"},{"key":"key20170419165017245_ref1-bib174","doi-asserted-by":"publisher","first-page":"104","DOI":"10.1093\/fampra\/12.1.104","article-title":"Qualitative research methods in general practice and primary care","volume":"12","author":"Britten","year":"1995","journal-title":"Fam Pract"},{"key":"key20170419165017245_ref1-bib175","volume-title":"Management of Diabetes: A National Clinical Guideline","author":"SIGN","year":"2013"},{"key":"key20170419165017245_ref1-bib176","doi-asserted-by":"publisher","first-page":"O1","DOI":"10.1186\/1745-6215-16-S2-O1","article-title":"Good practice principles for sharing individual participant data from publicly funded clinical trials","volume":"16","author":"Smith","year":"2015","journal-title":"Trials"}],"container-title":["Health Technology Assessment"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/publications\/hta21200\/hta21200.xml","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/njl-admin.nihr.ac.uk\/document\/download\/2002702","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/publications\/hta21200\/hta21200.xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/njl-admin.nihr.ac.uk\/document\/download\/2010386","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,15]],"date-time":"2023-08-15T15:40:39Z","timestamp":1692114039000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/hta\/hta21200"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,4]]},"references-count":176,"journal-issue":{"issue":"20","published-online":{"date-parts":[[2017,4]]}},"alternative-id":["10.3310\/hta21200"],"URL":"https:\/\/doi.org\/10.3310\/hta21200","relation":{},"ISSN":["1366-5278","2046-4924"],"issn-type":[{"value":"1366-5278","type":"print"},{"value":"2046-4924","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,4]]},"assertion":[{"value":"This content has been made freely available to all.","name":"free","label":"Free to read"}]}}