The next-generation platform was developed to ensure the immutability of data, enable on-premise flexible deployment, and provide improved analytics and dashboarding, says Litmus Health Chief Medical Officer Dr. Samuel Volchenboum.
“We needed to be able to provide sponsors and, ultimately, the FDA, with an ironclad lineage for their data,” Volchenboum told us. To achieve this, Chicago-based Litmus Health worked with a blockchain technology company, Sixgill, which provides universal sensor data automation services.
Implementation of the technology ensures all data is collected, stored, and analyzed in “an immutable, trackable, and auditable way,” said Volchenboum.
Additionally, while Litmus offers secure cloud services, it became evident that in some instances there would be a need to provide on-premise rollout, he added. Though not technically challenging, the on-premise capability needed to be reproducible, with good processes in place. Currently, Litmus is working with a pharma partner to provide these capabilities.
Litmus Health is currently part of a 500 patient, three-year study funded by Takeda Pharmaceuticals. Being run by Dr. David Rubin at the University of Chicago’s Digestive Diseases Center, the study has enrolled more than 200 patients of all ages.
The new platform is being rolled out to study participants, who have been quick to adopt the new technology, quelling initial fears that there would be pushback from patients not wanting to use their own phones or wearables, said Volchenboum.
The initial results are promising, he added, and include the discovery that passive biosensor monitoring can predict disease activity in inflammatory bowel disease (IBD) patients.
The third focus in developing the next-generation platform, which is HIPAA and 21 CFR Part 11 compliant, was to provide analytics in a way that was useful to clinicians and researchers.
“It’s one thing to say that you’ll provide machine learning to do modeling of events in patients using the data – it’s another to give researchers a dashboard where they can actually start playing with the data,” Volchenboum said.
The platform – in addition to FitBit and Garmin – now also supports Actigraph, an FDA-approved, medical-grade wearable for monitoring patient physical and sleep activity.
A changing conversation
Historically, the company’s conversations with pharma have centered around the industry’s fear of doing things differently. But Volchenboum said that conversation has really shifted, and much more so in the last six months.
“No longer are we trying to convince pharma that they need to do this,” he said. “I think it’s blowing wide open now and it’s a really exciting time to be in the space.”
Pharma – a cautious first, but quick second – is starting to see the power of wearables. “Nobody wants to be the last one to implement a wearable to monitor their patients at home,” said Volchenboum
Still, there is a need to temper expectations. “There is a real use for these technologies, but it has to be done in a way that is regimented and repeatable,” he added.
“Pharma all feel like they are late to the game, but they are all similarly late,” said Volchenboum. “Everybody has waited for somebody else to come out in front and do it … and now we’re starting to see this real rise of trials using this type of technology.”