Blog 12 – Verisense End Points and Metrics

The 12th edition of our blog series will focus on the clinical trial end points and metrics that are possible to explore using Shimmer’s Verisense platform.

Selecting the right clinical endpoint or outcome measure may be the most important factor in determining the success of a clinical trial and whether it truly reflects the performance of the drug or medical device. The use of wearables in clinical trials provides a tremendous opportunity to replace sporadic and sometimes subjective measures with objective continuous ones. The interest in such endpoint can be seen in some recent statistics from the Digital Medicine Society’s Library of Digital Endpoints (https://www.dimesociety.org/index.php/knowledge-center/library-of-digital-endpoints):

• The number of unique digital endpoints increased from 34 to 166 in the last 14 months, and the number of sponsors actively collecting digital endpoints in clinical trials of their medical products has increased from 12 to 52.

• Last year, 50% of digital endpoints being collected were being used in drug trials — this has increased to 62%

• There has been an increase in the use of digital clinical endpoints during the post-market phase of drug and biologic trials

When the libraries were launched a couple years ago, roughly 40% of digital endpoints were exploratory; now, they only account for just over 10% — indicating increasing confidence in their use. The challenge is that there are few established endpoints to choose from. As pointed out in a recent posting by the Digital Medicine Society’s Jennifer Goldsack, NONE of the 166 endpoints in the library has been used more than once.

Shimmer is strongly supportive of efforts to collaborate and establish standards, but until such standards exist, the key in selecting wearables will be flexibility.

The most flexible approach is to capture continuous raw data. For example, Shimmer’s Verisense IMU (inertial measurement unit with an accelerometer and gyroscope) is one such system. In addition, its flexible form factor allows it to be used in any location. The combination of these two factors enables any endpoint that can be determined by an accelerometer and/or a gyroscope can be calculated. This makes Verisense an enormously flexible platform that can be used by investigators for an almost unlimited number of applications.

Shimmer is also trying to do its part to support the development of standards. Shimmer is a founding member of the Open Wearables Initiative (owear.org) whose mission is to promote collaboration and open-source digital algorithms and datasets. Verisense’s built-in metrics employ the open-source GGIR algorithms which are becoming a de facto standard for activity and sleep metrics with over 150 peer reviewed papers and studies involving over 200,000 participants. Activity and sleep are probably the most fundamental indicators. The most commonly looked at activity metrics include time spent in: idle, light, moderate or vigorous activity. For sleep, the key metrics are total time in bed and sleep efficiency. With that said, there are a great deal of other metrics that can be looked at using the GGIR algorithm package that the Verisense IMU employs.

Sample activity and sleep metrics that can be measured using the Verisense IMU.

As Shimmer expands the Verisense platform to add PPG, SpO2, GSR, ECG and EMG sensors to the platform, we will continue to promote and leverage open-source solutions in our efforts to establish de facto standards that can be used by all. In all cases, we will continue to support providing complete raw data from these sensors as well, so any endpoint that uses these types of raw data can be explored using the Verisense platform.

With digital endpoints being used more extensively in clinical trials, it is an advantage to have a platform like Verisense that offers flexibility in new end points that you can measure because of the continuous data nature. Due to the flexibility of the platform, you may have questions about whether it is possible to look at a specific endpoint using Verisense. If you do have any questions, we are always here to help.