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The Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE): study protocol for a cluster randomised controlled trial.
BMJ Open. 2014 Sep 03; 4(9):e006204.BO

Abstract

INTRODUCTION

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.

Authors+Show Affiliations

Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.Division of Health Sciences, Warwick Medical School, University of Warwick, Warwick, UK.Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, UK.Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK.Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.School of Health and Related Research, University of Sheffield, Sheffield, UK.School of Health and Related Research, University of Sheffield, Sheffield, UK.Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, UK.No affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25186159

Citation

White, David, et al. "The Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE): Study Protocol for a Cluster Randomised Controlled Trial." BMJ Open, vol. 4, no. 9, 2014, pp. e006204.
White D, Waugh N, Elliott J, et al. The Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE): study protocol for a cluster randomised controlled trial. BMJ Open. 2014;4(9):e006204.
White, D., Waugh, N., Elliott, J., Lawton, J., Barnard, K., Campbell, M. J., Dixon, S., & Heller, S. (2014). The Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE): study protocol for a cluster randomised controlled trial. BMJ Open, 4(9), e006204. https://doi.org/10.1136/bmjopen-2014-006204
White D, et al. The Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE): Study Protocol for a Cluster Randomised Controlled Trial. BMJ Open. 2014 Sep 3;4(9):e006204. PubMed PMID: 25186159.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE): study protocol for a cluster randomised controlled trial. AU - White,David, AU - Waugh,Norman, AU - Elliott,Jackie, AU - Lawton,Julia, AU - Barnard,Katharine, AU - Campbell,Michael J, AU - Dixon,Simon, AU - Heller,Simon, AU - ,, Y1 - 2014/09/03/ PY - 2014/9/5/entrez PY - 2014/9/5/pubmed PY - 2015/6/24/medline KW - Diabetes Mellitus KW - Insulin Infusion Systems KW - Insulin/administration & dosage* KW - Patient Education as Topic/methods* KW - Type 1/therapy* SP - e006204 EP - e006204 JF - BMJ open JO - BMJ Open VL - 4 IS - 9 N2 - INTRODUCTION: 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. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/25186159/The_Relative_Effectiveness_of_Pumps_Over_MDI_and_Structured_Education__REPOSE_:_study_protocol_for_a_cluster_randomised_controlled_trial_ L2 - http://bmjopen.bmj.com/cgi/pmidlookup?view=long&pmid=25186159 DB - PRIME DP - Unbound Medicine ER -