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).
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Authors
REPOSE Study Group,
Publication Date
2017-03-30Journal Title
BMJ (Clinical research ed.)
ISSN
0959-8146
Publisher
The BMJ
Volume
356
Pages
j1285
Language
English
Type
Article
This Version
VoR
Physical Medium
Electronic
Metadata
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REPOSE Study Group,. (2017). 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).. BMJ (Clinical research ed.), 356 j1285. https://doi.org/10.1136/bmj.j1285
Abstract
Objective To compare the effectiveness of insulin pumps with multiple daily injections for adults with type 1 diabetes, with both groups receiving equivalent training in flexible insulin treatment.Design Pragmatic, multicentre, open label, parallel group, cluster randomised controlled trial (Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE) trial).Setting Eight secondary care centres in England and Scotland.Participants Adults with type 1 diabetes who were willing to undertake intensive insulin treatment, with no preference for pumps or multiple daily injections. Participants were allocated a place on established group training courses that taught flexible intensive insulin treatment ("dose adjustment for normal eating," DAFNE). The course groups (the clusters) were then randomly allocated in pairs to either pump or multiple daily injections.Interventions Participants attended training in flexible insulin treatment (using insulin analogues) structured around the use of pump or injections, followed for two years.Main outcome measures The primary outcomes were a change in glycated haemoglobin (HbA1c) values (%) at two years in participants with baseline HbA1c value of ≥7.5% (58 mmol/mol), and the proportion of participants achieving an HbA1c value of <7.5%. Secondary outcomes included body weight, insulin dose, and episodes of moderate and severe hypoglycaemia. Ancillary outcomes included quality of life and treatment satisfaction.Results 317 participants (46 courses) were randomised (156 pump and 161 injections). 267 attended courses and 260 were included in the intention to treat analysis, of which 235 (119 pump and 116 injection) had baseline HbA1c values of ≥7.5%. Glycaemic control and rates of severe hypoglycaemia improved in both groups. The mean change in HbA1c at two years was -0.85% with pump treatment and -0.42% with multiple daily injections. Adjusting for course, centre, age, sex, and accounting for missing values, the difference was -0.24% (-2.7 mmol/mol) in favour of pump users (95% confidence interval -0.53 to 0.05, P=0.10). Most psychosocial measures showed no difference, but pump users showed greater improvement in treatment satisfaction and some quality of life domains (dietary freedom and daily hassle) at 12 and 24 months.Conclusions Both groups showed clinically relevant and long lasting decreases in HbA1c, rates of severe hypoglycaemia, and improved psychological measures, although few participants achieved glucose levels currently recommended by national and international guidelines. Adding pump treatment to structured training in flexible intensive insulin treatment did not substantially enhance educational benefits on glycaemic control, hypoglycaemia, or psychosocial outcomes in adults with type 1 diabetes. These results do not support a policy of providing insulin pumps to adults with poor glycaemic control until the effects of training on participants' level of engagement in intensive self management have been determined.Trial registration Current Controlled Trials ISRCTN61215213.
Keywords
REPOSE Study Group
Sponsorship
This research was funded by the UK Health Technology
Assessment Programme (project No 08/107/01) and will be published in
full in Health Technology Assessment. See the HTA programme website
for further project information. (http://www.nets.nihr.ac.uk/). This report
presents independent research commissioned by the National Institute
for Health Research (NIHR). We also acknowledge financial support from
the Research and Development Programmes of the Department of
Health for England and the Scottish Health and Social Care Directorates
who supported the costs of consumables, and of Medtronic UK, which
provided the insulin pumps for the trial. These funders had no
involvement in the design of the protocol; the collection, analysis, and
interpretation of the data; the writing of this paper; or the decision to
submit this article for publication. The views and opinions expressed
herein are those of the authors and do not necessarily reflect those of
the HTA, NIHR, NHS, the Department of Health, or Medtronic UK.
Funder references
Department of Health (via University of Sheffield) (R/124553)
Identifiers
External DOI: https://doi.org/10.1136/bmj.j1285
This record's URL: https://www.repository.cam.ac.uk/handle/1810/296357
Rights
Attribution-NonCommercial 4.0 International
Licence URL: http://creativecommons.org/licenses/by-nc/4.0/
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