The REPOSE trial

The Relative Effectiveness of Pumps over MDI and Structured Education for Type-1 diabetes (REPOSE)

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Challenges

People with type 1 diabetes (T1DM) need insulin therapy to sustain life.

The most common treatment is injecting insulin several times a day. Another approach uses insulin pumps, the size of mobile phones, which are attached under the skin through fine tubing and which provide small amounts of insulin.

In the UK, pumps are recommended for people struggling to control their diabetes with injections, and are used far less often than in other countries.

Previous trials of pumps have been small and of short duration, and have failed to control for training in flexible insulin therapy.

The REPOSE trial aimed to assess the clinical effectiveness and cost-effectiveness of pump therapy compared with MDI for a wider population of adults with T1DM, with both groups receiving equivalent structured training in flexible insulin therapy.


Research

We undertook a pragmatic cluster randomised controlled trial involving 267 people with T1DM in eight secondary care centres across England and Scotland.

Participants were allocated a place on a week-long educational course (DAFNE, Dose Adjustment For Normal Eating) to learn about flexible insulin therapy.

Course groups were then randomly allocated into two groups: one group also received training on how to use a pump to deliver their insulin while the second group used multiple insulin injections, for two years.

The primary outcome was change in HbA1c (a standard surrogate measure of glycaemic control) at two years, in those participants who had a baseline HbA1c of ≥7.5%.

We also collected data at 6, 12 and 24 months on episodes of moderate and severe hypoglycaemia, biochemical outcomes and diabetic ketoacidosis.

Quality of life data were collected using participant self-completed questionnaires and qualitative interviews were undertaken with participants and staff to aid interpretation of the findings. The trial also included a cost-effectiveness analysis.


Results

Our results showed that both groups improved diabetes control after training. Participants using pumps had slightly better control, but differences were small (HbA1c was 0.24% lower than in the injections group).

We found that pumps were not cost-effective, although people using pumps reported better satisfaction with their treatment and in some aspects of their quality of life.

Our study suggests that making insulin pumps more widely available before structured training is unlikely to improve diabetes control or be cost-effective. Providing structured education to more people could be highly beneficial, with pumps made available to those needing better ways of delivering insulin to reach glucose targets.


Impact

The results have been provided to NICE. Our main recommendations were that although these data don’t directly affect NICE pump guidance since participants in REPOSE weren’t those currently those recommended for pump therapy, NICE should consider:

  1. The guideline on structured education is reinforced. Unfortunately this guidance has been poorly implemented and most patients with type 1 diabetes have not been offered evidence-based structured education.

    However NICE guidance currently highlights the importance of DAFNE as a high quality structured education programme in type 1 diabetes and NHS England has recently provided funding for greater provision to patients.
     
  2. The new HbA1c target in the updated type 1 guideline, coupled with the need to avoid hypoglycaemia, will probably need increased use of CSII, particularly those highly active in their own management.

    There is also a need to review the switching threshold of HbA1c of 8.5% in TA 151.

Trials registration


Study documents

Protocol v11.2 - 23 March 2015 (PDF, 677KB)


Publications

The REPOSE Study Group. 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 2017;356:j1285.

Pollard DJ, Brennan A, Dixon S, Waugh N, Elliott J, Heller S, Lee E, Campbell M, Basarir H & White D (in press). The cost-effectiveness of insulin pumps compared to multiple daily injections, both provided with structured education, for adults with type 1 diabetes: a health economic analysis of the relative effectiveness of pumps over structured education (REPOSE) randomised controlled trial. BMJ Open. View this article in WRRO

White D, Waugh N, Elliott J, Lawton J, Barnard K, Campbell MJ, 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:e006204. http://dx.doi.org/10.1136/bmjopen-2014-006204

Lawton J, Kirkham J, Rankin D, Barnard K, Cooper CL, Taylor C, et al. Perceptions and experiences of using automated bolus advisors amongst people with type 1 diabetes: a longitudinal qualitative investigation. Diabetes Res Clin Pract 2014;106:443–50. http://dx.doi.org/10.1016/j.diabres.2014.09.011

Lawton J, Kirkham J, White D, Rankin D, Cooper C, Heller S. Uncovering the emotional aspects of working on a clinical trial: a qualitative study of the experiences and views of staff involved in a type 1 diabetes trial. Trials 2015;16:3.


Project staff

Name Site Telephone number Email
Simon Heller
Chief Investigator
School of Medicine,
University of 91Ö±²¥
+44 (0)114 271 3204 s.heller@sheffield.ac.uk
Cindy Cooper
Director of CTRU
ScHARR +44 (0)114 22 20743 c.l.cooper@sheffield.ac.uk
Diana Papaioannou
Research Fellow
ScHARR +44 (0)114 22 20766 d.papaioannou@sheffield.ac.uk
David White
Trial Manager
ScHARR +44 (0)114 22 20807 d.a.white@sheffield.ac.uk
Gemma Hackney
Research Assistant
ScHARR +44 (0)114 22 24320 g.hackney@sheffield.ac.uk
Lucy Carr
Trials Support Officer
ScHARR +44 (0)114 22 20866 lucy.carr@sheffield.ac.uk
Tim Chater
Data Manager
ScHARR +44 (0)114 22 20876 t.chater@sheffield.ac.uk
Kirsty Pemberton
Data Officer
ScHARR +44 (0) 114 22 20861 k.j.pemberton@sheffield.ac.uk
Mike Campbell
Statistician
ScHARR +44 (0)114 22 20839 m.j.campbell@sheffield.ac.uk
Munyaradzi Dimairo
Statistician
ScHARR +44 (0) 114 222 5204 m.dimairo@sheffield.ac.uk
Simon Dixon
Professor of Health Economics
ScHARR +44 (0)114 22 20724 s.dixon@sheffield.ac.uk
Hasan Basarir
Health Economist
ScHARR +44 (0)114 22 26397 h.basarir@sheffield.ac.uk
Alan Brennan
Professor of Health Economics and Decisions Modelling
ScHARR +44 (0)114 22 20684 a.brennan@sheffield.ac.uk
Jen Kruger
Health Economist
ScHARR +44 (0)114 22 25207 j.kruger@sheffield.ac.uk
Dr Kath Barnard
Psychosocial Quantitative Research Fellow
University of Southampton + 44 (0) 2380 595548 K.Barnard@soton.ac.uk
Dr Julia Lawton
Qualitative Psychosocial Research Fellow
University of Edinburgh +44 (0) 1316 506197 j.lawton@ed.ac.uk
Professor Norman Waugh
Deputy Chief Investigator
University of Warwick   norman.waugh@warwick.ac.uk
Gill Thompson
National DAFNE director
Central DAFNE +44 (0) 1912 934023 gillian.thompson@northumbria-healthcare.nhs.uk

Participating centres

Centre name Principal Investigator Educators- DSNs and dieticians
91Ö±²¥ Teaching Hospitals NHS Foundation Trust Simon Heller
Co-investigator: Jackie Elliott
Carolin Taylor
Carla Gianfrancesco
Valerie Gordon
Val Nayor
Karen Towse
Addenbrookes Hospital, Cambridge Mark Evans
Co-investigator: Leila Faghahati
Candice Ward
Sara Hartnell
Sarah Donald
Katy Davenport
Kulbir Kaur Pabla
Jane Baillie
Karen Callaby
Helen Davies
Harrogate District Hospital Peter Hammond
Co-investigator: Sutapa Ray
Janet Carling
Joyce Lodge
Laura Dinning
King’s College Hospital, London Stephanie Amiel
Co-investigator: Pratik Choudhary
Anita Beckwith
Helen Rogers
Chris Cheyette
Vicky Deprez
Alison Cox
Philippa Marks
Dumfries and Galloway Royal Infirmary

Fiona Green
Co-investigator: Muna Mohammed

Pam Young
Sheena McDonald
Katy Valentine
Glasgow Royal Infirmary Robert Lindsay
Co-investigator: Brian Kennon
Janice Shepherd
Ann Boal
Bernadette Quinn
Emma Gibb
Royal Infirmary of Edinburgh Alan Jaap
Co-investigator: Alan Patrick

Alyson Hutchison
Debbie Anderson
Lindsay Aniello
Vida Heaney

Nottingham University Hospitals NHS Trust Peter Mansell
Co-investigator: Tasso Gazis

Nicola Maude
Janet Evans
Gayna Babington

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