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)
Authors: S Heller, Stephanie Amiel, Mark Evans, Fiona Green, Peter Hammond, Alan Jaap, Brian Kennon, Robert Lindsay, Peter Mansell, Jane Baillie, Anita Beckwith, Helen Brown, Karen Callaby, Katy Davenport, Sarah Donald, Jackie Elliott, Leila Faghahati, Sara Hartnell, Allison Housden, Kaur Kalbir, Nicola Pabla, Sheena Croxon, Muna Macdonald, Vicky Mohammed, Katy Steel, Pamela Valentine, Ann Young, Patsy Boal, Lynn Clerkin, Joanne Doran, Emma Flynn, Hilary Gibb, Bernie Peddie, Helen Quinn, Janice Rogers, Janet Shephard, Ann Carling, Laura Collins, Christine Dinning, Joyce Hare, Sutapa Lodge, Debora Ray, Jenny Brown, Alison Farmer, Chris Cox, Pratik Cheyette, Linda Choudhary, June East, Katherine Ellul, Kimberley Hunt, Ben Shaw, Lucy Stothard, Lindsay Diamond, Debbie Aniello, Kathy Anderson, Vida Cockerell, Alison Heaney, Nicola Hutchison, Gayna Zammitt, Gail Babington, Janet Bird, Tasso Evans, Nicola Gazis, Karen Maude, Dawn Nunnick, Laura Spick, Carla Fenn, Valerie Gianfrancesco, Linda Gordon, Susan Greaves, Valerie Hudson, Chloe Naylor, Carolin Nisbet, Karen Taylor, Candice Towse, Gemma Cooper, Diana Hackney, Emma Papaioannou, David Whatley, Michael Bradburn, Munya Campbell, Ellen Dimairo, Alan Hasan Basarir, Simon Brennan, Daniel Dixon, Nina Hallowell, Jackie Kirkham, Julia Lawton, David Rankin
Journal: BMJ (2017)

<b>Objective</b>&nbsp;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. <b>Design</b>&nbsp;Pragmatic, multicentre, open label, parallel group, cluster randomised controlled trial (Relative Effectiveness of Pumps Over MDI and Structured Education (REPOSE) trial). <b>Setting</b>&nbsp;Eight secondary care centres in England and Scotland. <b>Participants</b>&nbsp;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. <b>Interventions</b>&nbsp;Participants attended training in flexible insulin treatment (using insulin analogues) structured around the use of pump or injections, followed for two years. <b>Main outcome measures</b>&nbsp;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 &lt;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. <b>Results</b>&nbsp;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. <b>Conclusions</b>&nbsp;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. <b>Trial registration</b>&nbsp;Current Controlled Trials ISRCTN61215213.