Clinical Trials on AI-Assessed QTc Measurement Directly from Consumer Smartwatches

Since 2014, Cardiologs has been on a mission to democratize access to expert cardiac care through medical-grade artificial intelligence and cloud technology.

The Cardiologs Holter platform is a unique heart arrhythmia diagnostic software powered by Artificial Intelligence to streamline electrocardiogram analysisⁱ. In 2016, the solution became the world’s first medical device powered by deep learning technology to be CE-certified.

The next step to validate the true potential of Cardiologs’ unique AI software, is to combine it with data from consumer smartwatches, to ultimately enable highly accurate home-monitoring of patients all over the world. In 2020, Cardiologs launched initial clinical studies with data acquired directly in patient smartwatches. Additional studies will continue in 2021 and beyond.

Challenge

To validate that the Cardiologs algorithm can detect all heart arrhythmias based on single-lead electrocardiograms from consumer smartwatches, Cardiologs needed to collect and manage large amounts of data from multiple sources, including data collected directly in the Cardiologs software.

In the past, Cardiologs used Excel spreadsheets for their data collection and management. However, The Excel spreadsheet had several limitations: some recordings could be lost, data input and management was time consuming and it was difficult to get an overview of the data.

For the upcoming trials, Cardiologs needed to ensure:

• Secure data management with no risk of losing data
• Simplified data collection and management to minimize workload
• Direct data transfer from the Cardiologs software to a data management solution
• Fast and easy implementation and training
• Flexible setup to accommodate differing study design

Solution

Cardiologs selected SMART-TRIAL eCRF with an external API addon as the solution. This enabled them to run the studies in a single system while directly transferring data from the Cardiologs software to SMART-TRIAL.

Results

Replacing Excel spreadsheets with the SMART-TRIAL EDC platform helped Cardiologs overcome all challenges related to the data collection and management for the studies. Compared to the former solution using Excel spreadsheets, the three main improvements were:

• Significantly reduced time spent on data collection and management
• Zero loss of data
• Improved data oversight

“Using the SMART-TRIAL platform was really, really easy. Implementation was quick and painless, and the API connection with our own software saves an incredible amount of internal resources.” Audrey Plesse, Project Manager Clinical Affairs, Cardiologs.