The last patient has completed a clinical trial investigating the use of a digital platform to help patients with hypertension personalise and optimise their therapy regime.
The PERSONAL COVID BP clinical trial was organised by therapeutics company Closed Loop Medicine to assess the use of its smartphone app to monitor blood pressure in patients also receiving drug therapy for hypertension.
The technology used in the study allowed patients shielding from Covid-19 to report any disease related symptoms and control their blood pressure remotely on a daily basis from home. Closed Loop Medicine was forced to redesign the study throughout the Covid-19 lockdowns so they could run remotely and be conducted using the uMED decentralised clinical trial platform.
For the interventional arm of the study Closed Loop Medicine recruited over 200 patients, who then received drug therapy while using an app to monitor blood pressure and any potential side effects. Data from the study will be used to advance the company’s product that it hopes can deliver precision control of blood pressure at a population health scale.
The trial is part-funded by Innovate UK and was run by the William Harvey Clinical Research Centre at Queen Mary University of London, part of the National Institute for Health Research Biomedical Research Centre at Barts NHS Trust in London UK.
Dr Hakim Yadi, CEO & Co-Founder of Closed Loop Medicine said: “This represents a key milestone for the company, the last patient dosed and follow-up treatment completed in our interventional clinical study. Our aim is to improve patient outcomes while supporting health systems to better manage patients with long-term conditions through linked remote monitoring and precision drug intervention. The trial design allowed greater patient participation from the comfort and safety of their own home. I am delighted that we were able to successfully complete recruitment, despite the constraints of the COVID-19 pandemic. We look forward to presenting the results of this important trial alongside our partners at Queen Mary University of London.”
Dr David Collier, the lead trial investigator from Queen Mary University of London, added: “This is an important study in that it allows patients and physicians to collect real-world data to help better inform treatment decisions and monitor patient outcomes. Some of the drugs we use are great at preventing heart attacks and strokes, but frequently cause unwanted side-effects, something this trial sets out to address. We are demonstrating through this study that one size does not fit all, but that by using technology in this combined way, we can personalise treatment for the individual. This personalisation seems to have potential to change participants relationship to treatment, as they see the effect of different levels of treatment on their blood pressure whilst carefully checking for unwanted effects. This “personalised dose-response curve” has a meaning for participants and clinicians and we’re excited to confirm its impact on the whole group.”
“Participants, some over 80 years of age became very attached to their remote app and despite it prompting for daily blood pressure recording for three months were upset that they had to delete it at the end of the trial “It was like an angel at my shoulder” said one participant”.