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

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Tytuł:: The Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE): study protocol for a cluster randomised controlled trial.
Autorzy:: White D; Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.
Waugh N; Division of Health Sciences, Warwick Medical School, University of Warwick, Warwick, UK.
Elliott J; Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, UK.
Lawton J; Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK.
Barnard K; Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.
Campbell MJ; School of Health and Related Research, University of Sheffield, Sheffield, UK.
Dixon S; School of Health and Related Research, University of Sheffield, Sheffield, UK.
Heller S; Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, UK.
Corporate Authors:: REPOSE group
Źródło:: BMJ open [BMJ Open] 2014 Sep 03; Vol. 4 (9), pp. e006204. Date of Electronic Publication: 2014 Sep 03.
Typ publikacji:: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
Język:: English
Imprint Name(s):: Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
MeSH Terms:: Insulin Infusion Systems*
Diabetes Mellitus, Type 1/*drug therapy
Patient Education as Topic/*methods
Adult ; Glycated Hemoglobin/analysis ; Humans ; Injections, Intramuscular ; Insulin/administration & dosage ; Insulin/therapeutic use ; Treatment Outcome
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Grant Information:: 08/107/01 United Kingdom DH_ Department of Health
Contributed Indexing:: Keywords: Diabetes Mellitus; Insulin Infusion Systems; Insulin/administration & dosage*; Patient Education as Topic/methods*; Type 1/therapy*
Molecular Sequence:: ISRCTN ISRCTN61215213
Substance Nomenclature:: 0 (Glycated Hemoglobin A)
0 (Insulin)
0 (hemoglobin A1c protein, human)
Entry Date(s):: Date Created: 20140905 Date Completed: 20150622 Latest Revision: 20221207
Update Code:: 20240104
PubMed Central ID:: PMC4158215
DOI:: 10.1136/bmjopen-2014-006204
PMID:: 25186159
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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.
(Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

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