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Home > About BTT1D & Our Impact > Our research > Research projects > Better immunotherapy clinical trials for type 1 diabetes
Professor Colin Dayan
This project aims to overcome two major roadblocks to developing and licensing immunotherapies for people newly diagnosed with type 1 diabetes:
To do this, the researchers will use mathematical modelling to improve the way clinical trials are analysed for success.
In type 1 diabetes, the current way to tell how well a new immunotherapy treatment is working is to measure the amount of a molecule called C-peptide in the person’s blood after a meal.
C-peptide is made by the body when it creates insulin, so if there is more of it in the blood, then the person trying the treatment is making more insulin.
But this doesn’t take into account all the other outcomes that matter to people with type 1 – like the number of hypos they experience, or how difficult their blood glucose is to manage.
So, with this project, Professor Dayan aims to create a better way to test how well an immunotherapy is working.
To do this, he will adapt a system that already exists, called the BETA-2 score. BETA-2 is a combination of four measurements, and is used when people with type 1 are given a transplant of beta cells, to give doctors an idea of how effective the transplant has been.
By re-analysing data from more than 2,400 participants on 25 previous immunotherapy clinical trials, Professor Dayan will see if the BETA-2 score would have worked for these trials and, if so, how the score should be calculated.
He will also explore whether any other measurements could be added to the score to make it more accurate.
This should tell him the best set of measurements to take to accurately and quickly assess how well a new treatment is working.
This research, if successful, could make it possible to run trials more quickly and cheaply, making it easier to develop new treatments for type 1.
It would also make life easier for clinical trial volunteers, as the BETA-2 score can be calculated from one blood test, so does not require a full hospital visit.
The team will also work with medicine regulators in Europe and the US to ensure that this new test is rigorous enough to pass their standards for licensing new treatments – another vital part of speeding up the process of bringing a new treatment to people with type 1.
Breakthrough T1D UK is also co-funding Professor Dayan to lead the UK T1D Research Consortium. The consortium promotes immunotherapy research in type 1 diabetes, by running more clinical trials, and improving the way they are carried out.
This award will help to fund the next generation of immunotherapy research, enabling more efficient clinical trials, in more locations, so that promising treatments can reach people sooner.
Dr Bewick is exploring ways to improve the health, performance and number of beta cells in the body, so that people with type 1 can be less reliant on insulin pumps and injections – or even, one day, live without them completely.
This project is looking at a new way to turn stem cells into beta cells in the lab, to better understand what conditions make this process happen efficiently.
Dr Gavin Bewick is a researcher at King’s College London whose research focuses on the cells in the pancreas which produce and release insulin, the beta cells. He is currently developing a drug to protect these beta cells.