A cluster randomised trial, cost-effectiveness analysis and psychosocial evaluation of insulin pump therapy compared with multiple injections during flexible intensive insulin therapy for type 1 diabetes: the REPOSE Trial

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dc.contributor.authorHeller, Simon
dc.contributor.authorWhite, David
dc.contributor.authorLee, Ellen
dc.contributor.authorLawton, Julia
dc.contributor.authorPollard, Daniel
dc.contributor.authorWaugh, Norman
dc.contributor.authorAmiel, Stephanie
dc.contributor.authorBarnard, Katharine
dc.contributor.authorBeckwith, Anita
dc.contributor.authorBrennan, Alan
dc.contributor.authorCampbell, Michael J.
dc.contributor.authorCooper, Cindy L.
dc.contributor.authorDimairo, Munyaradzi
dc.contributor.authorDixon, Simon
dc.contributor.authorElliott, Jackie
dc.contributor.authorEvans, Mark
dc.contributor.authorGreen, Fiona
dc.contributor.authorHackney, Gemma
dc.contributor.authorHammond, Peter
dc.contributor.authorHallowell, Nina
dc.contributor.authorJaap, Alan
dc.contributor.authorKennon, Brian
dc.contributor.authorKirkham, Jackie
dc.contributor.authorLindsay, Robert
dc.contributor.authorMansell, Peter
dc.contributor.authorPapaioannou, Diana
dc.contributor.authorRankin, David
dc.contributor.authorRoyle, Pamela
dc.contributor.authorSmithson, W. Henry
dc.contributor.authorTaylor, Carolin
dc.contributor.funderNational Institute for Health Researchen
dc.date.accessioned2017-05-18T12:11:34Z
dc.date.available2017-05-18T12:11:34Z
dc.date.issued2017-04
dc.date.updated2017-05-18T11:53:32Z
dc.description.abstractBackground: Insulin is generally administered to people with type 1 diabetes mellitus (T1DM) using multiple daily injections (MDIs), but can also be delivered using infusion pumps. In the UK, pumps are recommended for patients with the greatest need and adult use is less than in comparable countries. Previous trials have been small, of short duration and have failed to control for training in insulin adjustment. Objective: To assess the clinical effectiveness and cost-effectiveness of pump therapy compared with MDI for adults with T1DM, with both groups receiving equivalent structured training in flexible insulin therapy. Design: Pragmatic, multicentre, open-label, parallel-group cluster randomised controlled trial, including economic and psychosocial evaluations. After participants were assigned a group training course, courses were randomly allocated in pairs to either pump or MDI. Setting: Eight secondary care diabetes centres in the UK. Participants: Adults with T1DM for > 12 months, willing to undertake intensive insulin therapy, with no preference for pump or MDI, or a clinical indication for pumps. Interventions: Pump or MDI structured training in flexible insulin therapy, followed up for 2 years. MDI participants used insulin analogues. Pump participants used a Medtronic Paradigm® VeoTM (Medtronic, Watford, UK) with insulin aspart (NovoRapid, Novo Nordisk, Gatwick, UK). Main outcome measures: Primary outcome – change in glycated haemoglobin (HbA1c) at 2 years in participants whose baseline HbA1c was ≥ 7.5% (58 mmol/mol). Key secondary outcome – proportion of participants with HbA1c ≤ 7.5% at 2 years. Other outcomes at 6, 12 and 24 months – moderate and severe hypoglycaemia; insulin dose; body weight; proteinuria; diabetic ketoacidosis; quality of life (QoL); fear of hypoglycaemia; treatment satisfaction; emotional well-being; qualitative interviews with participants and staff (2 weeks), and participants (6 months); and ICERs in trial and modelled estimates of cost-effectiveness. Results: We randomised 46 courses comprising 317 participants: 267 attended a Dose Adjustment For Normal Eating course (132 pump; 135 MDI); 260 were included in the intention-to-treat analysis, of which 235 (119 pump; 116 MDI) had baseline HbA1c of ≥ 7.5%. HbA1c and severe hypoglycaemia improved in both groups. The drop in HbA1c% at 2 years was 0.85 on pump and 0.42 on MDI. The mean difference (MD) in HbA1c change at 2 years, at which the baseline HbA1c was ≥ 7.5%, was –0.24% [95% confidence interval (CI) –0.53% to 0.05%] in favour of the pump (p = 0.098). The per-protocol analysis showed a MD in change of –0.36% (95% CI –0.64% to –0.07%) favouring pumps (p = 0.015). Pumps were not cost-effective in the base case and all of the sensitivity analyses. The pump group had greater improvement in diabetes-specific QoL diet restrictions, daily hassle plus treatment satisfaction, statistically significant at 12 and 24 months and supported by qualitative interviews. Limitation: Blinding of pump therapy was not possible, although an objective primary outcome was used. Conclusion: Adding pump therapy to structured training in flexible insulin therapy did not significantly enhance glycaemic control or psychosocial outcomes in adults with T1DM. Research priority: To understand why few patients achieve a HbA1c of < 7.5%, particularly as glycaemic control is worse in the UK than in other European countries.en
dc.description.sponsorshipNational Institute for Health Research (Health Technology Assessment programme)en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.citationHeller S, White D, Lee E, Lawton J, Pollard D, Waugh N, et al. (2017) ‘A cluster randomised trial, cost-effectiveness analysis and psychosocial evaluation of insulin pump therapy compared with multiple injections during flexible intensive insulin therapy for type 1 diabetes: the REPOSE Trial’, Health Technology Assessment, 21(20). doi:10.3310/hta21200en
dc.identifier.doi10.3310/hta21200
dc.identifier.endpage277en
dc.identifier.issn1366-5278
dc.identifier.issued20en
dc.identifier.journaltitleHealth Technology Assessmenten
dc.identifier.urihttps://hdl.handle.net/10468/3992
dc.identifier.volume21en
dc.language.isoenen
dc.publisherNational Institute for Health Researchen
dc.relation.ispartofCurrent Controlled Trials ISRCTN61215213
dc.rights© Queen’s Printer and Controller of HMSO 2017. This work was produced by Heller et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.en
dc.subjectQuality of lifeen
dc.subjectStructured education programen
dc.subjectPoor glycemic controlen
dc.subjectSevere hypoglycemiaen
dc.subjectInfusion CSIIen
dc.subjectDose adjustmenten
dc.subjectPatients experiencesen
dc.subjectClinical trialen
dc.subjectMetabolic controlen
dc.subjectTreatment satisfactionen
dc.titleA cluster randomised trial, cost-effectiveness analysis and psychosocial evaluation of insulin pump therapy compared with multiple injections during flexible intensive insulin therapy for type 1 diabetes: the REPOSE Trialen
dc.typeReporten
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