The Library
The relative effectiveness of pumps over MDI and structured education (REPOSE) : study protocol for a cluster randomised controlled trial
Tools
White, David, Waugh, Norman, Elliott, Jackie, Lawton, Julia, Barnard, Katharine D., Campbell, Michael J., Dixon, S. and Heller, Simon (2014) The relative effectiveness of pumps over MDI and structured education (REPOSE) : study protocol for a cluster randomised controlled trial. BMJ Open, Volume 4 (Number 9). e006204. doi:10.1136/bmjopen-2014-006204 ISSN 2044-6055.
|
PDF
BMJ Open-2014-White-.pdf - Published Version - Requires a PDF viewer. Download (962Kb) | Preview |
Official URL: http://dx.doi.org/10.1136/bmjopen-2014-006204
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.
Item Type: | Journal Article | ||||||||
---|---|---|---|---|---|---|---|---|---|
Subjects: | R Medicine > RC Internal medicine | ||||||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
||||||||
Library of Congress Subject Headings (LCSH): | Diabetes -- Treatment, Cluster analysis | ||||||||
Journal or Publication Title: | BMJ Open | ||||||||
Publisher: | BMJ | ||||||||
ISSN: | 2044-6055 | ||||||||
Official Date: | 2014 | ||||||||
Dates: |
|
||||||||
Volume: | Volume 4 | ||||||||
Number: | Number 9 | ||||||||
Page Range: | e006204 | ||||||||
DOI: | 10.1136/bmjopen-2014-006204 | ||||||||
Status: | Peer Reviewed | ||||||||
Publication Status: | Published | ||||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||||
Date of first compliant deposit: | 28 December 2015 | ||||||||
Date of first compliant Open Access: | 28 December 2015 | ||||||||
Funder: | Sheffield Teaching Hospitals NHS Foundation Trust |
Request changes or add full text files to a record
Repository staff actions (login required)
View Item |
Downloads
Downloads per month over past year