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 analysis. In 2016, the solution became the world’s first medical device powered by deep learning technology to be CE-certified.

To fully harness the true potential of Cardiologs' innovative AI software, the next phase involves integrating it with data from customer smartwatches. This integration aims to enable precise home monitoring of patients worldwide. In 2020, Cardiologs launched initial clinical studies using data collected directly from patient smartwatches. Further studies are scheduled for 2021 and beyond to build on these findings.

The Challenge

In order 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.

Historically, Cardiologs used Excel spreadsheets for their data collection and management. However, Excel had several limitations, including data loss, time-consuming data-input and management, and difficulty reviewing the data.

For the upcoming trials, Cardiologs needed to ensure:

• Secure clinical trial 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

The Solution

Cardiologs selected Greenlight Guru Clinical's eCRF (formerly SMART-TRIAL) with an external API add-on as the solution. This enabled them to run the studies in a single system while directly transferring data from the Cardiologs software to Greenlight Guru Clinical.

Results

Replacing Excel spreadsheets with the Greenlight Guru EDC platform helped Cardiologs overcome all challenges related to the data collection and management of 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