People aged 12 – 30, who have been diagnosed with type 1 diabetes within the last 100 days, may be eligible to participate.
Where is the trial being conducted and how long will it last?
This is an Australian-based trial being undertaken over two years at three sites in Melbourne Australia: The Royal Melbourne Hospital, The Royal Children’s Hospital Melbourne and St Vincent’s Hospital Melbourne and at one site in Adelaide Australia – the Women’s and Children’s Hospital.
Why should I participate in this trial?
If the drug helps to preserve a participant’s ability to make insulin, participants may find it easier to control glucose levels and may be able to decrease their insulin doses. Participants will help to advance type 1 diabetes research and may also benefit from the additional monitoring of their diabetes provided by the trial and from close interaction with the research team.
What kind of things will the trial participant have to do?
Participants will be asked to provide details of their medical history and be examined by a trial doctor.
Blood samples will be collected to check for blood cell counts, liver and kidney function, blood glucose levels and other measurements such as immune system genes, called HLA, which play an important role in the development of type 1 diabetes.
During the trial, participants will be asked to undertake meal tests, and have a glucose monitor fitted at times.
In between the trial visits at the hospital, a member of the trial team will contact participants regularly by telephone to enquire about any concerns and to review participant treatment with insulin.
Is there a cost to participate in the BANDIT trial?
No; all medication, tests and medical care required as part of the research project will be provided free of charge. Participants will be reimbursed for any reasonable travel, parking, meals and other expenses associated with the research project visit.
How will the trial work?
There will be two groups in this trial – two thirds of the participants will be given baricitinib (a tablet) and one third of the participants will be given a placebo (a tablet). A placebo looks like the real drug but has no active ingredients. The main reason to have a placebo group is to be sure that any effects that happen are caused by the treatment and not by something else.
How will participant privacy be managed?
All identifying information will be kept confidential.
When the results of this trial are known, they will be made available to participants who ask for them.
Who is leading the BANDIT trial?
The BANDIT trial is being led by St Vincent’s Institute (SVI) in Melbourne Australia, with funding provided by JDRF.