This model outlines the challenges participants encounter in maintaining diabetes self-management practice s after attending structured education , and describes how participants try to address these barriers by adapting , simplifying or personalising the self-management approaches they have learned .
Conclusions This meta-ethnography highlights how providing skills training using structured education to people with type 1 diabetes does not necessarily result in participants adopting and sustaining recommended changes in behaviour .
Background People with type 1 diabetes who attend structured education training in self-management using flexible intensive therapy achieve improved blood glucose control and experience fewer episodes of severe hypoglycaemia .
However , many struggle to sustain these improvements over time .
To inform the design of more effective follow-up support we undertook a review of qualitative studies which have identified factors that influence and inform participants ’ self-management behaviours after attending structured education  and their need for support to sustain improvements in glycaemic control .
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.
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 r and omised controlled trial , including economic and psychosocial evaluations . After participants were assigned a group training course , courses were r and omly 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 r and omised 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 underst and 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 IS RCT N61215213 . 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
This model outlines the challenges participants encounter in maintaining diabetes self-management practice s after attending structured education , and describes how participants try to address these barriers by adapting , simplifying or personalising the self-management approaches they have learned .
Conclusions This meta-ethnography highlights how providing skills training using structured education to people with type 1 diabetes does not necessarily result in participants adopting and sustaining recommended changes in behaviour .
Background People with type 1 diabetes who attend structured education training in self-management using flexible intensive therapy achieve improved blood glucose control and experience fewer episodes of severe hypoglycaemia .
However , many struggle to sustain these improvements over time .
To inform the design of more effective follow-up support we undertook a review of qualitative studies which have identified factors that influence and inform participants ’ self-management behaviours after attending structured education  and their need for support to sustain improvements in glycaemic control .