Tags

Type your tag names separated by a space and hit enter

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 Technol Assess 2017; 21(20):1-278HT

Abstract

BACKGROUND

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.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN61215213.

FUNDING

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 20. See the NIHR Journals Library website for further project information.

Authors+Show Affiliations

Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, UK.Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK.School of Health and Related Research, University of Sheffield, Sheffield, UK.Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.Diabetes Research Group, King's College London, London, UK.Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.King's College Hospital NHS Foundation Trust, London, UK.School of Health and Related Research, University of Sheffield, Sheffield, UK.School of Health and Related Research, University of Sheffield, Sheffield, UK.Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.School of Health and Related Research, University of Sheffield, Sheffield, UK.Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, UK.Institute of Metabolic Science, University of Cambridge, Cambridge, UK. Wolfson Diabetes Clinic, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.Dumfries Royal Infirmary NHS Trust, Dumfries, UK.Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.Harrogate and District NHS Foundation Trust, Harrogate, UK.Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK.Edinburgh Centre for Endocrinology and Diabetes, Royal Infirmary of Edinburgh, Edinburgh, UK.Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde, Glasgow, UK.Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK.Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.Nottingham University Hospitals NHS Trust, Nottingham, UK.Clinical Trials Research Unit, University of Sheffield, Sheffield, UK.Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK.Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.Department of General Practice, University College Cork, Cork, Ireland.Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28440211

Citation

Heller, Simon, et al. "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 (Winchester, England), vol. 21, no. 20, 2017, pp. 1-278.
Heller S, White D, Lee E, et al. 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 Technol Assess. 2017;21(20):1-278.
Heller, S., White, D., Lee, E., Lawton, J., Pollard, D., Waugh, N., ... Taylor, C. (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 (Winchester, England), 21(20), pp. 1-278. doi:10.3310/hta21200.
Heller S, et al. 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 Technol Assess. 2017;21(20):1-278. PubMed PMID: 28440211.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Heller,Simon, AU - White,David, AU - Lee,Ellen, AU - Lawton,Julia, AU - Pollard,Daniel, AU - Waugh,Norman, AU - Amiel,Stephanie, AU - Barnard,Katharine, AU - Beckwith,Anita, AU - Brennan,Alan, AU - Campbell,Michael, AU - Cooper,Cindy, AU - Dimairo,Munyaradzi, AU - Dixon,Simon, AU - Elliott,Jackie, AU - Evans,Mark, AU - Green,Fiona, AU - Hackney,Gemma, AU - Hammond,Peter, AU - Hallowell,Nina, AU - Jaap,Alan, AU - Kennon,Brian, AU - Kirkham,Jackie, AU - Lindsay,Robert, AU - Mansell,Peter, AU - Papaioannou,Diana, AU - Rankin,David, AU - Royle,Pamela, AU - Smithson,W Henry, AU - Taylor,Carolin, PY - 2017/4/26/entrez PY - 2017/4/26/pubmed PY - 2018/3/1/medline SP - 1 EP - 278 JF - Health technology assessment (Winchester, England) JO - Health Technol Assess VL - 21 IS - 20 N2 - BACKGROUND: 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. TRIAL REGISTRATION: Current Controlled Trials ISRCTN61215213. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 20. See the NIHR Journals Library website for further project information. SN - 2046-4924 UR - https://www.unboundmedicine.com/medline/citation/28440211/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_ L2 - https://doi.org/10.3310/hta21200 DB - PRIME DP - Unbound Medicine ER -