Clinical Trials
The Children's Diabetes Centre at PCH has a number of clinical trials currently open for recruitment in WA. This page explains what clinical trials are and why people are choosing to participate in clinical trials.
Clinical trials are the only way to generate the evidence needed to bring new immunotherapy treatments into the care of people living with type 1 diabetes (T1D).
Participation in a clinical trial provides the opportunity to access promising new treatments and to be cared for by a highly motivated team of specialists.
You can also benefit from the knowledge that your effort in participating in a clinical trial will help others affected by T1D, both now and into the future.
Frequently Asked Questions (FAQs) about clinical trials:
What is immune therapy for T1D?
Immune therapy is medication that may help protect insulin making cells in the pancreas.
Sometimes these medications will only be available to you through clinical trials.
What is an immune therapy clinical trial?
Clinical trials are research studies that aim to answer important questions about different diseases. Immune therapy clinical trials ask these questions to better understand how medications may help people. Some of these questions may include:
- Does the medication have any side effects?
- Is the medication safe?
- Does the therapy work?
- Does it work the same or better than other medications for the same conditions?
Sometimes medications being trialled are already approved and used in other conditions but are being researched to see if they will work in a new condition. This is the case for many of the immune therapies being trialled in T1D.
Joining a clinical trial at PCH means having visits with our research nurses and doctors. During these visits you may need to have blood tests or other investigations to answer some (or all) of the questions above. Our team works with your family to make these visits enjoyable and rewarding.
What is a placebo and why are they needed?
A placebo is a medication that’s made to look the same as the study medicine but does not contain any real medicine.
A placebo is needed to confirm the results seen in the trial are because of the study medicine and not because of other coincidental factors, like changes in lifestyle or the environment.
Are there any immune therapy medications for T1D available in Australia outside of clinical trials?
You may have heard of teplizumab in the media. Teplizumab is an immune therapy and is the first of its kind to be proven to potentially delay the onset of stage 3 T1D.
It has been approved in other parts of the world since 2022.
In May 2026, it was government approved for people with Stage 2 T1D, ages 8 and older in Australia. However, the Australian government does not subsidise the cost of teplizumab yet. This means that the main route to access teplizumab is still through clinical trials.
There are many other immune therapies being trialled currently and this area of diabetes care is growing and changing rapidly. Your clinical team will be able to keep you updated as things change.
What does Stage 2 mean?
Our understanding of how to define T1D has changed. We can now test people for T1D autoantibodies, these autoantibodies are markers of an immune attack on the pancreas and especially the cells that make insulin (beta cells).
If somebody has 2 or more autoantibodies they are considered to have early-stage T1D. This means that even though they don’ t have symptoms yet, they have a close to 100% chance of progressing to insulin requiring symptomatic T1D, known now as stage 3 T1D. If somebody has a single autoantibody, they are also at risk of developing stage 3 T1D.
Early-stage T1D is currently classified into two stages: stage 1 and stage 2.
- Stage 1 is when you have 2 or more diabetes autoantibodies with normal blood sugar levels.
- Stage 2 is the same, however with abnormal blood sugar levels that are not yet consistently high enough to need insulin therapy.
For those with early-stage T1D we don’t yet know how long it takes to progress to stage 3 T1D. We do know those with stage 2 T1D are more likely to progress quickly. This is why immune therapies are increasingly being directed towards this group.
Many trials are also aimed at those in stage 3 T1D. This is with the aim to preserve the insulin producing cells in the pancreas for as long as possible. We hope that this may lead to easier management of T1D.
What Immunotherapy trials are open currently at our site:
For people living with Stage 2 - Delay onset of stage 3 T1D
BARICADE- DELAY
Ages 1 to 18 years
8kg and over
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For people living with Stage 3 - Preservation of beta cell function
BARICADE-PRESERVE
Ages 1 to 18 years
8kg and over
*Within 100 days of diagnosis
SAFEGUARD
Ages 5-18 years (currently only recruiting 12 and up)
16kg and over
*Within 100 days of diagnosis
BETA-PRESERVE
Ages 1-18 years
33.8Kg
*Within 56 days of diagnosis
*Must be given the study drug by this timeframe. Each study requires at least 4 weeks prior to these dates for screening to occur and results to be reviewed prior to entering the treatment period.
Who to contact if you have questions?
First published Wednesday 8 July 2026.
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