REPOSE V1

• Research type

  Research Study

• Full title

  The Relative Effectiveness of Pumps Over MDI and Structured Education.

• IRAS ID

  49441

• Contact name

  Simon Heller

• Sponsor organisation

  Sheffield Teaching Hospitals NHS Foundation Trust

• Eudract number

  2010-023198-21

• Research summary

  Are Insulin Pumps or Multiple Insulin Injections More Effective in Treating Adult Type-1 Diabetic Patients when Combined with DAFNE (Dose Adjustment for Normal Eating) Education? The precise benefit of insulin infusion pumps for adults with type-1 diabetes and the number who might benefit from such treatment is unclear. The aim of this study is to assess whether multiple injections or insulin infusion is the most effective treatment after a DAFNE (Dose Adjustment For Normal Eating) education course. 280 participants will be randomised from 7 NHS sites to either a standard course or one in which pump training is given. We will evaluate at baseline, 6 months, 1 year and 2 years with biomedical (HbA1c, a measure glycaemic control, weight), psychosocial (quality of life, treatment satisfaction, interviews) and health economic measures. The project is funded by the HTA (Health Technology Assessment) in the hope of establishing any benefit of pump therapy over diabetes education training so that the Department of Health may guide commissioning bodies for provision of pumps in the future.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  11/H1002/10

• Date of REC Opinion

  27 Apr 2011

• REC opinion

  Further Information Favourable Opinion