The Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE): study protocol for a cluster randomised controlled trial

dc.contributor.authorWaugh, Norman
dc.contributor.authorElliott, Jackie
dc.contributor.authorWhite, David
dc.contributor.authorLawton, Julia
dc.contributor.authorBarnard, Katharine
dc.contributor.authorCampbell, Michael J.
dc.contributor.authorDixon, Simon
dc.contributor.authorHeller, Simon
dc.contributor.funderNational Institute for Health Researchen
dc.contributor.funderDepartment of Health, Social Services and Public Safetyen
dc.contributor.funderScottish Government Health and Social Care Directorateen
dc.contributor.otherSmithson, W. Henry
dc.description.abstractIntroduction: People with type 1 diabetes (T1DM) require insulin therapy to sustain life, and need optimal glycaemic control to prevent diabetic ketoacidosis and serious long-term complications. Insulin is generally administered using multiple daily injections but can also be delivered using an infusion pump (continuous subcutaneous insulin infusion), a more costly option with benefits for some patients. The UK National Institute for Health and Care Excellence (NICE) recommend the use of pumps for patients with the greatest need, citing insufficient evidence to approve extension to a wider population. Far fewer UK adults use pumps than in comparable countries. Previous trials of pump therapy have been small and of short duration and failed to control for training in insulin adjustment. This paper describes the protocol for a large randomised controlled trial comparing pump therapy with multiple daily injections, where both groups are provided with high-quality structured education. Methods and analysis: A multicentre, parallel group, cluster randomised controlled trial among 280 adults with T1DM. All participants attended the week-long dose adjustment for normal eating (DAFNE) structured education course, and receive either multiple daily injections or pump therapy for 2 years. The trial incorporates a detailed mixed-methods psychosocial evaluation and cost-effectiveness analysis. The primary outcome will be the change in glycosylated haemoglobin (HbA1c) at 24 months in those participants whose baseline HbA1c is at or above 7.5% (58 mmol/mol). The key secondary outcome will be the proportion of participants reaching the NICE target of an HbA1c of 7.5% (58 mmol/mol) or less at 24 months. Ethics and dissemination: The protocol was approved by the Research Ethics Committee North West, Liverpool East and received Medicines and Healthcare products Regulatory Agency (MHRA) clinical trials authorisation. Each participating centre gave National Health Service R&D approval. We shall disseminate study findings to study participants and through peer reviewed publications and conference presentations, including lay user groups. Trial registration number ISRCTN 61215213.en
dc.description.sponsorshipNational Institute for Health Research (UK Health Technology Assessment Programme: Project Number 08/107/01); Department of Health, Social Services and Public Safety (Research and Development Programme); Scottish Government Health and Social Care Directorate (Research and Development Programme)en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.identifier.citationWhite, D., Waugh, N., Elliott, J., Lawton, J., Barnard, K., Campbell, M. J., Dixon, S. and Heller, S. on behalf of the REPOSE group (2014) 'The Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE): study protocol for a cluster randomised controlled trial'. BMJ Open, 2014(4), e006204 (9pp). doi:10.1136/bmjopen-2014-006204en
dc.identifier.journaltitleBMJ Openen
dc.publisherBMJ Publishing Group Ltd.en
dc.rights© 2014, the Authors. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work noncommercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
dc.subjectInsulin pumpen
dc.subjectDiabetes education programmeen
dc.subjectMultidose insulinen
dc.titleThe Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE): study protocol for a cluster randomised controlled trialen
dc.typeArticle (peer-reviewed)en
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