REPOSE Impact Case Study

REPOSE: Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes

Key features

• Two year study: November 2011- April 2013

• 267 patients with type 1 diabetes recruited to the study across eight sites

• Funded by the NIHR Health Technology Assessment programme and supported by the NIHR Sheffield Clinical Research Facility

• NIHR provided research nurse and infrastructure support

• Chief Investigator: Professor Simon Heller, Sheffield Teaching Hospitals NHS Foundation Trust

• The study was the largest randomised trial of insulin pumps in type 1 diabetes ever conducted at the time

The hormone insulin, produced by the pancreas, is responsible for controlling the amount of glucose in the blood. Type 1 diabetes is a condition where the pancreas is not able to produce insulin and causes high blood sugar (glucose) levels. It affects around 250,000 people in the UK.

The REPOSE trial aimed to compare the clinical effectiveness and cost-effectiveness of insulin pumps with multiple daily injections for adults with type 1 diabetes, with both groups receiving training in flexible insulin treatment (a course of treatment where a patient can adjust the amount of insulin they take at each dose).

Patients with this form of diabetes need to supply insulin using either injections or a pump to keep blood glucose at a normal level. Insulin is usually injected daily and the dose is changed to fit with food intake and exercise.

Insulin pumps are portable devices, attached to the body by a long, thin piece of tubing, with a needle at the end, which is inserted under the skin. The pump delivers insulin into the bloodstream at a rate the patient can control. They are an alternative to insulin injections and reduce the need for daily multiple insulin jabs, although patients do need to monitor their blood glucose levels very closely to ensure they are receiving the right amount of insulin.

The use of pumps is expensive compared to injections.

NICE has approved the use of insulin pumps for type 1 diabetes for those patients who have the greatest need. They are used by around seven per cent of patients in the UK.

Participants undertook a week-long educational course (DAFNE, Dose Adjustment For Normal Eating) to learn about flexible insulin therapy. The group then split into two. One group also received training on how to use a pump to deliver their insulin while the second group used multiple insulin injections for two years.

Outcomes and findings

The REPOSE study found that people with type 1 diabetes using insulin pumps did not achieve better blood glucose control compared with those using multiple daily injections. Offering pumps to adults whose blood glucose levels are high and who have not yet received training in insulin self-management does not appear to offer additional benefit. However, both groups improved diabetes control after training. While most measures showed no difference between groups, people using pumps reported better satisfaction with their treatment and in some aspects of their quality of life, such as dietary freedom and daily hassle.

The study found that pumps were not cost-effective.

Value to the NHS

The study was the largest randomised trial of insulin pumps in type 1 diabetes ever conducted at the time. Previous trials of pumps have been small and of short duration, and have failed to control for training in flexible insulin therapy. The results support NICE guidelines around the restricted use of insulin pumps. The results show the importance of training to enable patients to better manage their diabetes and that guidance on structured education should be reinforced. Currently just ten per cent of adults with type 1 diabetes access these training courses.

The guidance has been poorly implemented and most patients with type 1 diabetes have not been offered evidence-based structured education. However, NICE guidance does highlight the importance of DAFNE as a high quality structured education programme in type 1 diabetes and NHS England has since provided funding for greater provision to patients.

Education remains crucial to improving the quality of life for people with type 1 diabetes. Our study suggests that providing structured insulin self-management training to more people could be highly beneficial, alongside making pumps available to those needing better ways of delivering insulin to reach glucose targets.

Professor Simon Heller, Professor of Clinical Diabetes at the University of Sheffield and NIHR National Specialty Lead for Diabetes

Key publications:

• Study site: www.sheffield.ac.uk/scharr/sections/dts/ctru/repose

• BMJ http://www.bmj.com/content/356/bmj.j1285

• NIHR Journals Library https://www.journalslibrary.nihr.ac.uk/hta/hta21200/#/abstract