One form of cheap and convenient RWD that is increasingly being collected comes from wearable devices such as smart watches, heart rate monitors, or continuous glucose monitors.
Around 3.4 million people in the U.S. are diagnosed with epilepsy each year. Of these, around 30%, have uncontrolled epilepsy and struggle to become seizure free. These individuals are at increased risk of sudden, unexpected death in epilepsy (SUDEP) and around 65,000 people die from this each year.
Ray Iskander is co-founder and CEO of Novela Neurotechnologies, also known as Neureka AI, which is aiming to improve the symptoms of epilepsy and reduce the risk of SUDEP through use of the company’s wearable and AI-based technology.
The company produces a ring wearable that uses photoplethysmography to monitor heart rate during sleep and another called SeizureLink, which is an armband that attaches around the bicep and monitors surface electromyography data in the muscles to predict seizures.
“It’s an electric signal in the muscle that gets triggered by the neural activities when a seizure happens,” explained Iskander. “It detects with very high precision the tonic-clonic seizures that are the primary cause of SUDEP.”
The company is combining data from a free app, that patients can use to track their symptoms and treatments, with wearable and other clinical and real-world data and analyzing it with the help of artificial intelligence.
Iskander points out that there is a particular need for this kind of real-world approach in epilepsy, as to monitor a patient today in a clinical trial setting you have to put a patient in an epilepsy monitoring unit. This is a highly monitored hospital setting that you can only really keep a patient in for a few days.
“What if you had the ability to get lower quality data, but over longer periods of time and from the convenience of a patient’s home,” suggested Iskander.
The company provides wearables for patients with epilepsy and their healthcare providers, but also wants to use its technology to help improve clinical trials for patients with epilepsy. “Making it very convenient over longer periods of time is a really good, cost-efficient benefit… You can imagine now that it’s much simpler to do 6–12-month clinical trials from home and collect data with much more precision than we used to do before,” said Iskander.
Data privacy is an important consideration when designing wearable technology for health purposes, but Iskander says the convenience for patients and the amount of longitudinal data that can potentially be collected for use in clinical studies is hard to beat.
“I think the accuracy of what we’re doing in the normal daily conditions of patients is improving and it’s potentially going to be a very powerful way to collect those data,” he emphasized.