For Trial Participants

You are being invited to take part in a research study. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether you wish to take part.

More information on this condition

These links contain information that we hope will be useful to patients taking part in the EXTOD study.

Who can enter the study?

For you to enter the study, you must be

1) age 16 and 60 years

2) diagnosed with T1D within the previous twelve weeks

3) feel able to increase your current levels of exercise

4) safe to exercise

5) willing to self-monitor and record blood glucose levels

6) willing to take insulin as part of a multiple dose injection regime

 

Some people are not suitable to enter the study. This includes those who have

1) physical or psychological disease that prevents exercise

2) concomitant therapy that affects heart rate (e.g. beta blocker, calcium channel antagonist)

3) major surgery or other event planned that would prevent exercise for more than six weeks

4) pregnancy or planning pregnancy,

5) uncontrolled blood pressure (greater than 180/100mmHg)

Tests and examination

If you agree to take part in this study, you will be asked to help in one of 2 ways

1) You will be asked to attend a 1-2 hour interview to find out from yourself what the problems are to doing exercise. This may be an individual interview or in a group with other patients with T1D.

or

2) You will be placed at ‘random’ in one of 2 groups: One group will be asked to have ‘usual diabetes care’. The other will be asked to undertake more ‘exercise’, and supported to do this. This group will be helped through provision of membership to leisure centres, gyms or swimming pools. They will also be provided advice and guidance to ensure that this exercise does not result in hypoglycaemia (low blood sugar), as well as motivational contact from diabetes nurses and dieticians. This ‘exercise’ group will be asked to maintain this level of exercise for 1 year

Both groups (the ‘exercise’ as well as the ‘usual care’ groups) will have blood tests taken at 0, 3, 6, 9 months, and after a year. There will also be urine tests and tests of your fitness levels (on an exercise cycle) at 0 and 6 months, as well as after a year. There will also be periods when we check your blood glucose by continuous glucose monitoring, a procedure where we get a very accurate picture of your glucose levels over a 1-2 week period. This study will finish after this one year

Participating centres


View EXTOD - Participating Centres UK in a larger map

The following hospitals are involved in the EXTOD study:

  • University Hospital Birmingham
  • Musgrove Park Hospital, Taunton
  • Bristol Royal Infirmary, Bristol
  • Southmead Hospital, Bristol
  • Gloucester Royal Hospital, Gloucester
  • Yeovil District Hospital, Yeovil
  • Queen Elizabeth Hospital, Welwyn Garden City
  • Pinderfields Hospital, Wakefield
  • Churchill Hospital, Oxford
  • Alexandra Hospital, Redditch
  • George Eliot Hospital, Nuneaton
  • Russell’s Hall Hospital, Dudley
  • Walsall Manor Hospital, Walsall
  • New Cross Hospital, Wolverhampton
  • Birmingham Heartlands Hospital, Birmingham
  • Good Hope Hospital, Birmingham
  • City Hospital, Birmingham
  • Cheltenham General Hospital, Cheltenham
  • Weston General Hospital, Weston super Mare
  • Frenchay Hospital, Bristol
  • Royal United Hospital, Bath
  • Royal Devon and Exeter Hospital, Exeter