Blog 21 - Adding Wearable Sensors to Clinical Trial Protocols
While the use of wearable sensors has grown exponentially over the last decade and according to research by Kaiser Associates and Intel (1), 70% of clinical trials will incorporate sensors by 2025, we still find in our experience many trial managers are unsure on how to best integrate wearable sensors into a clinical trial protocol. They are conscious of not wanting to add undue workload to study personnel or participants. This blog aims to give guidance on how the Verisense IMU sensor for activity and sleep can be seamlessly integrated into a trial protocol with minimal burden on sponsors, sites and participants.
Setting up a sensor and participant
A key objective in the development of the Verisense platform is that the burden on the site admin is kept to the absolute minimum. Regardless of the protocol requirements for wearing the sensor, one constant requirement in onboarding a participant for the wearable portion of the study is setting up the sensor, Base Station phones and providing these to the Participant. From our own estimates, and backed up by feedback from sites, we estimate that this process takes less than 10 minutes. Generally the actions are:
One time Only - Register and create login details for web portal (approx. 1 minute) – see demo video here
Add Participant IDs to the web portal (approx. 30 seconds per ID added) – see demo video here
Activate Base Station (approx. 2 minutes) – see demo video here
Setup and pair sensor to a Participant ID and provide this equipment to that Participant for them to take home (approx. 3 minutes) – see demo video here
Provide instructions on wearing the sensor and compliance requirements for meeting the study protocol (approx. 1 minute)
Optional - Create Compliance Analysis Period (approx. 1 minute) – see demo video here
Wear Time Requirement -> Protocol
Building out the remaining protocol after initial setup is largely based on the wear time compliance requirements of the Sponsor. These can be quite varied; we’ve seen numerous different requirements. Let’s look at a few typical examples and how a protocol was developed to fit that requirement.
Example 1
Requirement to collect 5 days of continuous 24/7 activity and sleep data (raw accelerometer only) between site visits (28 days) for 10 months. Daily upload of data to monitor compliance was required.
At onboarding the participant was advised of the wear requirement and provided the Sensor and Base Station to enable daily uploading of data. In this example a Compliance Analysis period was setup by the site admin and the Verisense dashboard was able to provide a day-by-day update on the wear compliance. If the period between site visits was running out and no wear had yet been detected, the site admin would receive an alert to advise the participant they needed to start the wear period promptly.
On site visits the Site admin had x4 actions:
On monthly site visits (x9 in total), change sensor battery (approx. 1 minute) – see demo video here
Perform Manual Upload if necessary (approx. 1 minute) – see demo video here
a) Should automated upload malfunction for any reason
Review previous wear time with the Participant and remind them of the wear compliance requirements for the study (approx. 2 minutes)
Create Compliance Analysis Period for the coming period of 28 days (approx. 1 minute)
Final requirement from the site admin was to unpair the participant and sensor from the trial on completion of the 10 months. Unpairing takes approx. 2 minutes, see demo video here.
The Participants requirements were very straightforward, wear the sensor for 5 days continuously between site visits and keep the Base Station plugged in receiving power. They did not need charge the sensor, upload data or anything else.
Example 2
Requirement to collect 6 months of continuous 24/7 activity and sleep data (raw accelerometer only). Weekly upload of data to monitor compliance was required.
In this scenario, the long-lasting battery of Verisense only necessitated monthly visits at two and four-month intervals.
The Site admin and Participant requirements were similar to Example 1, with the only change for the Participant being to continually wear the Sensor.
Example 3
Requirement to collect 2 months (60 days) of continuous 24/7 activity and sleep data (raw accelerometer only). No upload of data to monitor compliance was required.
The main difference to the protocol in this example is that with the long-lasting battery and onboard memory capability of up to 82 days, no interim site visits were required. Furthermore, the participant did not require a Base Station in their home. They were simply given the Sensor at the setup visit and handed it back 2 months later. The Site admin then performed a manual upload to retrieve all the data stored onboard the Sensor.
Conclusion
As the above examples show, Verisense’s flexibility with long-lasting battery and memory storage, in addition to the automated upload allows our sensor to be integrated seamlessly into a wider Clinical Trial protocol. True to our stated ambition in developing Verisense, burden on both the sites and participants is minimal.
1 - Jansen, Y. and Thornton, G. (2020) Wearables & Big Data In Clinical Trials — Where Do We Stand? Clinical Leader. https://www.clinicalleader.com/doc/wearables-big-data-in-clinical-trials-where-dowe-stand-0001
