The study aims to validate the development of a new combination product that links a drug to a smartphone app, allowing patients to personalize and optimize their treatment regimen to treat hypertension and prevent heart attacks and strokes cerebrovascular
The trial, called PERSONAL COVID BP, was partly funded by Innovate UK and led by the William Harvey Clinical Research Center at Queen Mary University of London
The last of 200 patients with hypertension completed the 14-week treatment phase as well as the required follow-up period of 2-4 weeks
Full study results are expected in Q2 2022 and will be presented to the American College of Cardiology (ACC) for presentation at the ACC Annual Scientific Session in April 2022 in Washington DC
Closed Loop Medicine Ltd, a leader in the development of products combining single prescription medicine and digital therapy (DTx) to enable precision dosing and care, today announced that the last patient has completed participation in a clinical trial of the company’s integrated precision care product solution for hypertensive patients.
Closed Loop Medicine develops digital drug and therapeutic combinations focused on dose optimization to improve patient outcomes, support clinicians, and enable evolution towards a value-based medicine proposition for healthcare systems. health by providing precision care at the population health scale.
The clinical trial, called PERSONAL COVID BP, aimed to determine if a combination product that combines a drug with a smartphone app can allow patients to personalize and optimize their treatment regimen for treating hypertension. Importantly, the technology in the study allowed patients protected against COVID-19 to report symptoms related to COVID-19 infection as well as monitor their blood pressure remotely, daily, from their residence. The company quickly evolved its approach to continuing studies during the COVID-19 lockdown, redesigning studies to run remotely and through technology development, including using the Decentralized Clinical Trials Platform uMED.
The interventional arm of the study exceeded its enrollment goal of 200 patients, with patients receiving drug therapy while using an app to monitor blood pressure and any potential side effects. The data from this study is being used to drive the development of the company’s highly innovative product that will provide precise blood pressure control at the population health scale. Product will save lives by tackling the Western world’s number one killer (1), high blood pressure – which even in the pre-vaccination year of COVID-19 in 2020 killed more people than cancer or COVID-19 (2).
Preliminary data from this study will be presented at the ACC’s 71st Annual Scientific Session, April 2-4, live in Washington, DC. They will also be published online in the Journal of the American College of Cardiology (JACC).
The trial is partly funded by Innovate UK and was conducted by the William Harvey Clinical Research Center in Queen Mary University of Londonwhich is part of the Biomedical Research Center of the Barts NHS Trust National Institute for Health Research in London, UK.
Following Closed Loop Medical’s success in securing a place in the Association of British HealthTech Industries (ABHI) American Accelerator Program earlier in January 2022, the company is exploring other clinical opportunities within the US healthcare system to support the development of its new precision care product for patients with hypertension.
Dr. Hakim Yadi OBE, CEO and Co-Founder of Closed Loop Medicine commented:
This represents a key milestone for the company, the last patient treated and follow-up treatment completed in our interventional clinical study. Our goal is to improve patient outcomes while helping healthcare systems better manage patients with long-term conditions through linked remote monitoring and precision medication intervention. The trial design allowed for greater patient participation in the comfort and safety of their own home. I am delighted that we were able to complete the 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 principal investigator of the trial from Queen Mary University of London, commented:
This is an important study in that it allows patients and doctors 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, which is what this trial aims to address. We demonstrate through this study that there is no one-size-fits-all solution, but by using technology in this combined way, we can personalize treatment for the individual. This personalization appears to have the potential to change participants’ relationship to treatment, as they see the effect of different levels of treatment on their blood pressure while carefully checking for adverse effects. This “personalized dose-response curve” has meaning for participants and clinicians and we are delighted to confirm its impact on the whole group. »
“The participants, some over 80, became very attached to their remote app and despite it prompting them to record their blood pressure daily for three months, they were upset that they had to delete it at the end. of the essay. “It was like an angel on my shoulder” said one participant.