The REPOSE (Relative Effectiveness of Pumps Over MDI and Structured Education) Trial

What Was Tested

The trial (phase 3) is built around Insulin Detemir.

For type-1 diabetes, the aim of insulin therapy is to keep blood glucose close to normal while avoiding hypoglycaemia but this is severely limited by the relative crudeness of current insulin delivery in comparison with the physiology of the β-cells which secrete insulin.

Insulin can now also be administered using a pump (CSII), which is a device, roughly the size of a mobile phone and containing sufficient insulin to supply both the needs of basal metabolism throughout the day, and the boluses which have to cover meals.

It had two arms (groups): Multiple daily injections plus DAFNE (active comparator) and CSII (Insulin Pump) plus DAFNE (experimental).

Optimised MDI therapy using rapid and twice daily (Detemir/Levemir) long-acting insulin analogues.

Medtronic MiniMed Paradigm Veo Insulin pumps (X54).

The registry classes the interventions as other.

More on the Plan

This will mean that in total on the trial, 140 participants are randomised to CSII and 140 to MDI.

Participants will be recruited through direct approach if already on the waiting list for a DAFNE course or through advertisement in various clinics.

Who Took Part

267 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Is aged 18 yrs and above. Have had type-1 diabetes for at least 12 months (as assessed by date clinically diagnosed). Is fluent in speaking, reading and understanding English. Has no preference to either CSII or MDI arm of the study and is happy to be randomised. Is currently using or willing to switch to Detemir.

The full record lists 7 inclusion and 14 exclusion criteria; among the exclusions: inability to give informed consent; is pregnant or planning to become pregnant within the next 2 years; has used csii within the last 3 years.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Insulin Detemir study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin Detemir group and the comparison group ran side by side rather than switching.

Being open-label, the Insulin Detemir study did not mask who received what.

It started in 2011-11 with completion listed for 2015-06.

It ran at 8 sites in United Kingdom (8).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 17 secondary outcomes, for example Diabetes specific quality of life, Hypoglycaemia (severe & moderate), Body weight, Blood lipids & proteinuria, Diabetic Ketoacidosis and Fear of hypoglycaemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Detemir in 267 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Detemir compound page, all human trials.