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)

Abstract

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) ABSTRACT ObjeCtive 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. PartiCiPantsAdults 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.interventiOns Participants attended training in flexible insulin treatment (using insulin analogues) structured around the use of pump or injections, followed for two years. Main OutCOMe MeasuresThe 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 <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. results 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. COnClusiOnsBoth 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. trial registratiOn Current Controlled Trials ISRCTN61215213.

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

“…A cluster design was chosen because of the impracticality of randomising individuals and then finding suitable times for that participant to attend a course of the correct allocation. 23 Such an approach was more likely to have resulted in significantly higher attrition rates pre course. Following the course, participants received the trial treatment for 2 years and outcome measures were collected at 6, 12 and 24 months post course.…”

“…23 In many DAFNE centres, reimbursement for pump use is conditional on patients having attended a DAFNE education course and so some patients undertake DAFNE training with the intention of moving to pump treatment thereafter. It has been our clinical experience that many individuals decide not to switch to the pump after attending a DAFNE course, as they then realise that what they required was training in insulin self-adjustment rather than a different technical way of delivering insulin.…”

“…2,25,26 To our knowledge, no trials in adults, comparing pump treatment with modern MDI, used the same structured training in insulin adjustment, resulting in the added benefit of the pump technology remaining unclear. 23 There was an urgent need to establish this, and identify patients who benefit the most. A RCT was needed to establish these outcomes without bias.…”

The danger of misinterpreting studies

“…1 A case in point is how it has been reported in widely read outlets such as Medscape (http://www.medscape.com/viewarticle/ 855508) and how it can be interpreted in non-specialist circles, especially amongst payers. The impact could be far-reaching in crunched financial environments such as the NHS where efficiency drive is sometimes restricted to yearly financial sheets and thereby interpreted as cost savings by reducing perceived 'expensive' investments such as insulin pumps, while the case for long-term financial savings in appropriate patients has been made and is clarified in relevant NICE guidelines.…”

2nd Annual National ABCD IPN-UK meeting

“…1 As readers will be aware, the REPOSE trial was recently published in the BMJ. The main aim of the study was to answer the questions 'Are pumps for all?'.…”