A new technology that is capable of transferring data from wearable devices to a cloud platform accessible to clinical study teams in real time is being put through its paces in several pilot programs around the world.

Actigraph, which is headquartered in Pensacola, Florida, has long been known as a developer of clinical-grade wearable devices. Now it has developed the CentrePoint Data Hub, which is designed to connect clinical trial participants with research teams without having to use their own personal computers or smartphones.

A compelling need in the world of academic research and clinical trials is that of real-time data capture to help measure anything from patient compliance to quality of life, and to be able to do it “as quickly and as efficiently as possible,” said Matt Biggs, Actigraph’s vice president of Account Services and Named Accounts.

Actigraph calls the CentrePoint Data Hub a “cellular communication gateway” that can easily be put in a trial participant’s home. It is a plug-and-play device that can synch with wearable Actigraph activity monitors—using Bluetooth and cellular technology—to securely transmit data to the CentrePoint Cloud software platform, where it is available to study teams in real time.

According to Actigraph, the Data Hub can also integrate with other types of connected sensors, simplifying and streamlining data collection from multiple channels.

One of the pilot sites is the Moffitt Cancer Center in Tampa. The Moffitt pilot study is part of a larger trial assessing the sickness behaviors (fatigue, depression, disruption in sleep and physical activity) in gynecologic cancer patients treated with chemotherapy. The Actigraph CentrePoint Data Hub is being used to follow patients over the course of nine different weeks in order to gather data about compliance, physical activity and sleep behavior, said Heather Jim, Ph.D., a postdoctoral fellow in behavioral oncology research at the H. Lee Moffitt Cancer Center & Research Institute.

There are several key challenges when it comes to having patients use wearable devices for clinical studies, said Dr. Jim.

These include:

• Ensuring that the patient is really using the wearable device.
• Making it as easy as possible for the patient to interact with the wearable technology.
• Receiving the data intact.

“For example, if you have something that is connected and uploaded through an app, for many people that’s no big deal,” she explained. “But for many cancer patients—many who may be older—they may not have smartphones, or really don’t know how to download the app and how to use the app to pull the data out of the wearable. So anything you can do to take away those additional responsibilities and make things simpler for the patient is going to ensure that you are going to get better data collection.”

In the case of the CentrePoint Data Hub, data is automatically uploaded to the CentrePoint Cloud from the patient’s own home without the need for a personal computer, smartphone or WiFi connection.

“Patients can be monitored from their own home, reducing the number of site visits,” said Biggs, who pointed out that many patients in clinical trials may have issues that curtail their physical activity or ability to drive. “We need a way to capture this data in the patient’s home without burdening them.”

With this in mind, the development of the CentrePoint Data Hub was an “exciting development,” Jim said. Not only do some patients have issues with compliance or dealing with wearable technology, she pointed out, but a damaged wearable—without the ability to monitor patients in real time—results in a lot of lost data.

“But, with the hub, it’s a very passive process for the participants. The only thing they have to do is plug it in,” she said. “As long as the [wearable] is close to the hub, it will upload the data once a day. We can monitor whether they are wearing it in real time, and reach out to them and troubleshoot if they aren’t. We’re able to capture all that data as it accrues, so that’s a real advantage.”

Actigraph is testing the Hub at several other sites around the world involved in academic research and pharmaceutical clinical trials in different therapeutic areas, Biggs said.

The Actigraph CentrePoint Data Hub is designed to be a “global cellular hub,” said Biggs, so Actigraph has pilot sites around the globe, including Europe, Japan, South America and the East and West Coasts of the U.S.

“First, we want to see how people react to this new technology, and second, we want to monitor its functionality and its ability to be scaled,” Biggs said. “We need real-world data capture in many different regions of the world to ensure [the technology] can be scaled up for global population studies or multiple site studies.”

This article was reprinted from Volume 21, Issue 18, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »