USTEKID – Phase II multi-centre, double-blind, randomised trial of Ustekinumab in adolescents with new-onset type 1 diabetes
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Friday update for the USTEKID trial:
1) no new patients - still holding at 6 patients consented (5 eligible)
2) Site training at St George's, London this week with Dr Chen and colleagues
Getting ready to visit St George's Hospital, London tomorrow to train them for the USTEKID trial with @T1D_UK ! I wish @premierinn did loyalty points for all the travelling I'm doing at the moment!
Friday update for the USTEKID trial:
1) 6 patients consented (5 eligible)
2) 4 sites open to recruitment
3) Site training at Leicester Royal Infirmary this week with Dr Greening and co (watch this space any one aged 12-18y newly diagnosed with T1D @LEdiabetesforum)
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 “Getting Involved” button below:
Eligibility to take part
- Age 12-18 years
- Diagnosed with type 1 diabetes in the last 100 days
- Commenced on insulin within 1 month of diagnosis
- Body weight < 100kg
- Evidence of body still making some insulin
- 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
Funded by the National Institute of Health Research Efficacy and Mechanism Evaluation (NIHR EME) programme.
CLOUD – Closed Loop from Onset in type 1 Diabetes
Recruiting sites:
- Cambridge University Hospitals NHS Foundation Trust
- Alder Hey Children’s NHS Foundation Trust
- Nottingham Children’s Hospital
- Oxford Children’s Hospital
- Southampton Childrens Hospital
- Royal Hospital for Sick Children, Edinburgh
Summary
CLOuD is a multicentre, randomised trial of an exciting new artificial pancreas device, in newly diagnosed adolescents with type 1 diabetes (T1D) funded by the EME Programme (an MRC and NIHR partnership) and the Helmsley Charitable Trust. The artificial pancreas is designed to mimic the normal healthy activity of beta-islet pancreatic cells in response to blood glucose levels. The device is a closed loop system combining real time continuous glucose monitoring with insulin pump therapy and a computer-based algorithm to calculate the amount of insulin required to keep blood glucose levels within target range. The aim is to prolong residual insulin secretion after T1D diagnosis, via intensive metabolic control using the artificial pancreas closed loop system, in order to minimise long-term complications and reduce the risk of hypoglycaemia. This is the first trial of its kind analysing the use of the artificial pancreas in newly diagnosed T1D patients.
96 participants aged 10 to 16 will be recruited within 10 working days of diagnosis of Type 1 Diabetes from 5 UK sites and will be randomised 1:1 to either closed loop or standard therapy (Multiple Daily Injections). Participants will have study visits and assessments every 3 months for a total of 24 months.
Research study for people with Type 1 Diabetes: EXALT
Recruitment Closed
03/11/2017
Summary
The main purpose of this study is to assess the safety of three different doses of an investigational drug in patients who have been recently diagnosed with type 1 diabetes.
The investigational drug is a “therapeutic vaccine” and affects the body’s immune system response to a medical condition or disease. It is designed to stop the immune system from attacking cells that produce insulin, which may help insulin production in patients with recently diagnosed type 1 diabetes.
In this study, patients will receive 4 injections of the investigational drug over a period of 6 weeks. Total study participation will last approximately 24 weeks, which includes 8 study clinic visits for various tests and evaluations.
All study-related visits, tests, and drugs will be provided at no cost. In addition, reimbursement for study-related time and travel may be provided.
To pre-qualify for this study, you must:
- Be 18 to 30 years of age
- Have been diagnosed with type 1 diabetes in the last 6 months
- Have an insulin requirement
If you are interested in taking part please complete the Getting Involved form.
The Effect of Abatacept on the Immune System in Type 1 Diabetes
Recruitment Closed
Recruiting Site: Guy’s Hospital
09/08/2017
Summary
This study aims to gain a better understanding of the immune processes that lead to the destruction of insulin producing beta cells. Participants will be given the drug Abatacept for 6 months, in addition to their regular diabetes medication. They will have blood tests before, during and after treatment (6 visits in all) so that we can analyse their immune cells.
We are looking for male and female volunteers aged 18-45 who have been diagnosed with Type 1 Diabetes in the last 100 days.
If you are interested in taking part please complete the Getting Involved form.
The Effect of Anti-IL-21 and Liraglutide in Newly Diagnosed Type 1 Diabetes
Recruitment Closed
Recruiting T1D UK Sites: Bristol, Birmingham, Cardiff, London QMUL, Newcastle, Sheffield, Swansea
Other participating sites: Belfast, Blackburn, London Imperial College, Plymouth Stevenage
Summary
This study will investigate if a new drug Anti-IL-21 when given together with another drug marketed for type 2 diabetes called liraglutide can preserve the beta cells in subjects diagnosed with type 1 diabetes.
The study is for adults aged 18-45 years who have been diagnosed with type 1 diabetes within 20 weeks of the screening visit.