The new blood collection device, known as BloodTrackR, has the potential to allow rheumatoid arthritis sufferers to detect the first signs of a flare-up of their condition at home. Chief among the researchers’ goals for the new device is that it will not only be reliable and robust in its design and execution, but supremely user-friendly.
Principal investigator on this project is Dr David Gibson, research group lead of the Personalised Medicine Centre and senior lecturer at the School of Biomedical Sciences at Ulster University. “Trying to get the right medicine to the right patient at the right time is the fundamental philosophy of our work,” he explains.
A biochemist by trade, Gibson has been involved in arthritis research for over 15 years. He says that rheumatoid arthritis is a painful condition that is characterised by stiff and swollen joints. At times, this can significantly worsen, known as a flare-up.
“These are episodes where symptoms get worse,” Gibson explains. “They are usually more frequent when a patient’s treatment isn’t working very well. Doctors need to be able to identify these flares to reduce damage to the joint because if we don’t do that really well, then there is a high risk of disability as the joints are getting damaged on a regular basis.” This also has the potential to cause heart problems, due to the systemic nature of the condition, he adds.
It's about them becoming empowered to look after their own condition and be involved in that process
As yet there are no fully tested options available to safely and reliably collecting blood samples to monitor these flare-ups when a person is at home. During the Covid-19 pandemic, however, the myriad benefits of remote monitoring became apparent, Gibson says. “The pandemic has really focused everybody’s attention on how we can make it easier to monitor long-term health conditions when people are away from the clinic and alleviate pressure on the healthcare service as well.”
Moreover, the old model of “doctor to patient” medicine is being replaced by one that sees people living with arthritis emerging as the experts in their own condition and taking a lead role in its management. “It’s about them becoming empowered to look after their own condition and be involved in that process,” Gibson says
With the BloodTrackR device, there is the potential to not only monitor the condition remotely while the person living with arthritis is at home, but potentially adjust their treatment remotely too. “Overall it makes it more efficient for the health service but the person at the centre is also given better care.”
The researchers are currently working to test and develop the device through a series of user-experience workshops, where every three months they seek patient feedback on a new iteration of the device, along with new software. A two-year project, the hope is that by the end of this period the team will have developed “a robust, user friendly device” from a regulatory standpoint, and an accompanying mobile app, which could then be utilised in clinical trials or healthcare.
The BloodTrackR project aims to incorporate as much user feedback as possible. “It’s a truly patient-driven project, with input from people living with arthritis at every step of the journey,” Gibson says. “We used it to conceive the study but we even asked for patient input into the ethics and the design of the study and how it’s run and eventually reported.”
This multi stakeholder project sees the Ulster University team of researchers working closely with patient groups, clinicians, medical scientists, med tech experts and the pharmaceutical industry. “The pharmaceutical sector is very interested in this area because during the pandemic a lot of clinical trials could not happen because people couldn’t physically come to trial centres due to Covid-19,” Gibson notes.
“This whole idea of decentralised clinical trials or essentially remote monitoring means you can have somebody enrolled in a clinical trial who uses one of these devices and doesn’t have to come into a centre. If we can get this adopted into clinical trials, we can see the testing of this device accelerated to a point where it could be more widely implemented in healthcare.”
It's the leading cause of disability in Ireland and the UK and we underestimate its impact on the population
Yet this area of connected health is highly regulated, meaning many regulatory hurdles that must be cleared and long lead-in times for any new technology. “We have the challenge of making the device functional and do exactly what we want to do, and also build future scope for more new technologies, which has been quite a challenge technically,” he says. “But we also have the regulatory challenges - it is quite a long time scale to develop a device, test it in patients which is what we are doing now, then it will have to be tested in the clinical environment where the bottom line will be, does it improve health outcomes and is it cost-effective?”
With nearly one in three people affected by arthritis or other musculoskeletal conditions, however, the potential positive impact of this device is obvious and this is what drives the researchers, Gibson says. “It’s the leading cause of disability in Ireland and the UK and we underestimate its impact on the population, and the problems it causes people on a daily basis.”
The end user remains at the forefront of their mind the whole time, he adds. “It has to fit in with their busy lifestyle - they may be balancing work and their condition. If the device can prevent them from having to leave work and go to a hospital when they have a flare-up then obviously that would be extremely useful.” Encouragingly, feedback from people with arthritis has been “overwhelmingly positive” so far, he adds. “The general view is that anything that can improve their situation and help them manage their condition proactively is very welcome.”