Wearable devices are playing an increasingly important role in remote monitoring for patients with a range of chronic conditions.
From monitoring heart rate, to blood pressure, oxygen levels and body temperature, these discreet devices such as smart rings and watches can record patient data and also transmit it to physicians to help in treatment and diagnosis for conditions such as Atrial Fibrillation (AF).
But an important element of this is in establishing just how effective these devices are.
To support this medical advance and innovation within a clinical setting, the Sky Labs CART-I plus is being used in a number of clinical trials to assess the value of smart devices in supporting patients in a relevant and meaningful way.
Sky Labs has provided CART-I plus for a clinical study led by cardiologist and arrhythmia specialist Professor Timothy Betts, who is a key figure for clinical research in cardiac rhythm management and an associate professor of cardiovascular medicine at Oxford University.
The study involves 50 patients at Oxford University Hospitals (OUH) NHS Foundation Trust to assess whether smart rings and watches can offer an accurate and reliable way to detect AF.
AF patients are advised to take anticoagulants to prevent the risk of stroke, but it is not easy to identify the symptoms.
Professor Betts is conducting a clinical study with Sky Labs CART-I plus to detect AF symptoms and alert the patients to take anticoagulants when needed.
CART-I plus is the world’s first ring-type heart-monitoring device and monitors heart signals and detects diseases by using a photoplethysmography (PPG) sensor in the ring, which monitors the bloodstream in the finger and continuously measures the irregular pulse waves of AF. Electrocardiogram (ECG) can be also measured.
For the study, 50 patients will have the Medtronic Reveal LINQ II implantable cardiac monitor (ICM) inserted and then use a Sky Labs CART-I plus or an Apple Watch to detect AF symptoms and alert the patients to take anticoagulants when needed. It will also note if patients acknowledge the alert.
The ability of the ring and the watch to monitor heart rhythm and alert AF episodes will be analysed in comparison with the ICM.
The ultimate goal is to use the data collected to guide anticoagulant treatment so that AF patients take anticoagulation only when they need it.
The study has received a grant of around £150,000 from the charity Heart Research UK. AF is the most common heart rhythm problem and causes an irregular and fast heartbeat, which makes the heart pump poorly. As a result, blood clots may form inside the heart and, if they travel to the brain, can lead to an AF-related stroke. The risk of stroke in patients with AF is five times higher than in people with normal rhythm, hence the need for anticoagulants.
Kate Bratt-Farrar, Chief Executive of Heart Research UK, said: “We are confident that Professor Betts’ project can bring about real and tangible improvements in how we treat patients, using technology that is both non-invasive and simple to use.”
Sky Labs is also involved in clinical trials with (University Medical Centers) UMC Amsterdam, is collaborating with doctors and researchers in South Korea, and seeking collaboration partners in the United States. Sky Labs is currently running a clinical study on the use of the smart ring for continuous blood pressure monitoring, with results due to be published early next year.
CART platform has already proved effective in long-term continuous monitoring for AF, with accuracy of 96.9%.
Sky Labs’ CART-I plus won the Digital Health & Technology Competition of the European Society of Cardiology for two consecutive years from 2018 and the company was selected as the ‘technology pioneer’ of the World Economic Forum 2019.