USTEKID – Phase II multi-centre, double-blind, randomised trial of Ustekinumab in adolescents with new-onset type 1 diabetes

Recruitment temporarily closed due to COVID-19 outbreak

Summary

Trial of a new medication in people with Type 1 diabetes aged 12-18 and within 100 days of diagnosis.

Aim

To investigate whether this medication can delay or halt the damage to the pancreas of people recently diagnosed with type 1 diabetes, making it easier to achieve optimal diabetes control in the early years following diagnosis.

If you are interested in taking part, please click the “Get Involved” button below:

Eligibility to take part

  1. Age 12-18 years
  2. Diagnosed with type 1 diabetes in the last 100 days
  3. Commenced on insulin within 1 month of diagnosis
  4. Body weight < 100kg
  5. Evidence of body still making some insulin
  6. Able and willing to record data for the study

What will I be asked to do?

We will ask you to agree to being tested to see if your body is still making some insulin on its own. If it is, we can include you in the study and give you the study drug or a placebo (dummy medicine). You will have injections of the study medicine or placebo 7 times over 44 weeks. You will also be asked to provide blood and urine samples at study visits and you will be asked to complete three short questionnaires.

If you are aged between 12-15, your parent/carer will be asked to agree to you taking part.

Who is running this study?

This study is being run by Cardiff University and Swansea University. It is funded by the National Institute of Health Research Efficiency and Mechanism Evaluation (NIHR EME) programme. The hospitals listed below will be participating in the study:

Hospitals taking part so far:

  • University Hospital of Wales, CARDIFF
  • Noah’s Ark Children’s Hospital for Wales, CARDIFF
  • Tayside Children’s Hospital, DUNDEE
  • Royal Devon and Exeter Hospital, EXETER
  • Royal Aberdeen Children’s Hospital, ABERDEEN
  • Morriston Hospital, SWANSEA
  • Leicester Royal Infirmary, LEICESTER
  • St George’s Hospital, LONDON
  • St James University Hospital, LEEDS
  • Royal Alexandra Children’s Hospital, BRIGHTON
  • The Royal London Hospital (Barts), LONDON
  • Norfolk and Norwich University Hospital, NORWICH
  • Evelina children’s hospital, LONDON
  • Countess of Chester Hospital, CHESTER

External Links

Funded by the National Institute of Health Research Efficacy and Mechanism Evaluation (NIHR EME) programme.

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Things to do when self-isolating - creation by a fellow Diabetes UK clinical champion - Dr Rose Stewart

We understand that our families are concerned about COVID-19 (Coronoavirus). There is no evidence at present that children and young people with diabetes are more at risk of getting COVID-19. However we realise that it is more difficult to manage diabetes when you are unwell.

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