19 Nov. 2020. A clinical trial is testing a combination of smartphone reporting and medication to help individuals personalize their blood pressure therapy. Closed Loop Medicine, in Cambridge, U.K., developer of the remote medication-management system, began enrolling participants with hypertension, or high blood pressure, in the trial.
Closed Loop Medicine calls itself a new type of therapeutics company that joins currently approved drugs with digital devices such as diagnostics and smartphones to offer more personalized health care to individuals than is possible with conventional practices. Patients today, says the company, can only see their doctors infrequently, often requiring patients to piece together their recollections of symptoms happening weeks or months earlier. Closed Loop says its systems offer a faster and tighter feedback loop between patient and physician, making it possible to deliver more personalized prescriptions for drugs, behavioral changes, or lifestyle modifications.
The company says the Covid-19 pandemic creates an even more urgent need for remote health care management systems. A review of 17 million electronic health records published in July and cited by Closed Loop Medicine, shows an association between hypertension and death from Covid-19 infections, particularly for people under the age of 70.
The clinical trial, called Personal Covid BP, aims to find out if remote diagnostics and reporting, combined with medications, can help individuals with high blood pressure manage their condition and personalize their care. The study, conducted at Queen Mary University of London, is enrolling 1,000 people who will record their blood pressure, and any associated symptoms, in a smartphone diary app, for three months. All participants will also be able to schedule telemedicine consultations with a physician during the trial.
A subgroup of 200 trial participants will be randomly assigned to receive amlodipine, a calcium-channel blocker drug that relaxes blood vessels to enable the heart to pump blood more normally. Data from these participants, including blood pressure readings and symptom reports, are expected to help physicians find an optimum dosage level for the drug that keeps blood pressure under control while minimizing adverse side effects.
“Our aim,” says Closed Loop Medicine CEO Hakim Yadi in a company statement, “is to improve patient outcomes while supporting health systems to better manage patients with long-term conditions through remote monitoring and timely intervention. The trial design allows greater patient participation from the comfort and safety of their own home whilst also investigating the potential link between Covid-19 and hypertension.”
David Collier, lead trial investigator for Queen Mary University adds, “We hope that through this study we can not only demonstrate that one size does not fit all, but that by using technology in this combined way, we can personalize treatment for the individual at a population scale.”
The trial is funded by a £250,000 award ($US 331,000) from Innovate UK, the government’s funding body for businesses translating scientific research into new products and services.
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