Joining the RADIAL trial

Being in a clinical trial creates a new structure in your life where you will have a clear set of personal responsibilities and frequent contact with healthcare professionals. It has been shown that being in a clinical trial (regardless of the medication that is provided) can improve glucose management, presumably because trial participants get more medical attention than usual and begin to feel empowered and supported to make changes in their self-care.^1,2

Your current long-acting insulin will be switched to the long-acting insulin, Toujeo®, which may help you improve your blood glucose management. You may also join the trial when you are already using Toujeo® as your current long-acting basal insulin.

Some published studies have shown Toujeo® to have advantages among long-acting basal insulins in terms of keeping glucose levels stable and reducing the risk of hypos ^3,4,5,6. You’ll be given clear guidance on how to adjust the dose of Toujeo® yourself, which will put you in control of your glucose management. When the trial is over, you can talk to your own doctor about prescribing Toujeo® for you, if you’d like to continue with it.

All participants who take part from their home will use the latest technology. This will include video calls with the trial doctor, a ‘smart’ cap for your insulin pen – which automatically captures the dose, date and time of each injection – and a connected glucometer, which automatically transmits your blood glucose readings to your trial apps and the research team.

Alongside the potential personal benefits, joining the RADIAL trial means you will be helping to shape the future of clinical trials. This in turn could accelerate medical progress. Because decentralised (home-based) trials have the potential to make clinical research in general more convenient and more accessible for participants, it is likely that more people will decide to take part in future research. So, your efforts to focus on your own health as a RADIAL participant will also make you a research pioneer.

You may already be accustomed to finger-pricking but the thought of doing this on a daily basis may not be appealing. That is completely understandable. But this will provide you with vital information about how to adjust your insulin dose and gain the benefits, so the researchers will be relying on you to do this regularly. You will also have other responsibilities including recording information through trial apps. If you decide to join the trial, you’ll need to take these responsibilities seriously.

Although being in the RADIAL trial could improve your blood glucose management, this is not guaranteed. It is also possible that you might experience side effects, but of course this can also happen in usual diabetes care. It’s important to remember that Toujeo® is an approved treatment which many people with diabetes around the world are taking.

Finally, you’ll need to become accustomed to the technologies that enable participation in the trial without visiting a hospital clinic. However, you will be given training and IT support throughout the trial whenever needed.