Scripps, Scanadu finalize 4K+ vital sign trial enrollment, FDA-ready data due in 2016

Scanadu Scout--Courtesy of the Scripps Translational Science Institute

Hand-held vital sign monitor Scanadu has made a big splash with its Indiegogo crowdfunding campaign that was followed up by being selected as a finalist in the $10 million Qualcomm Tricorder Xprize competition last year. Now it's working to legitimize its Scanadu Scout wireless vital sign monitor in a massive trial of more than 4,000 people conducted by Scripps Translational Science Institute.

The study results are intended to be part of a submission for the Scanadu Scout to the U.S. Food and Drug Administration, the company said. But the trial could have a bit of a positive bias, due to enthusiastic participants who were recruited from the more than 5,000 people in the U.S. who invested in the Scout via a record-breaking Indiegogo campaign that closed in July 2013 and raised almost $1.7 million in a month.

"The goal of this study is to see how using an innovative vital sign monitor influences the emotions and decision-making process of device users," Dr. Steven Steinhubl, who is director of digital medicine at Scripps Health and oversees wireless technology studies at STSI, said in a statement. "It's important to better understand these behaviors as more health information is collected by new devices like the Scanadu Scout."

STSI is a nonprofit, National Institutes of Health-sponsored consortium led by Scripps Health in collaboration with The Scripps Research Institute.

The 6-month trial is slated to evaluate users' perception of Scout's ease of use; how the device affects various health behaviors such as physician communication; and medication adherence. Participants use the device as often as they like to measure their heart rate, blood pressure, blood oxygen level and temperature.Trial data is wirelessly transmitted to a smartphone app accessible to participants and researchers. In addition, web-based surveys will be conducted thrice during the trial evaluation.

The Scout is roughly the size and shape of a small makeup compact. It includes multiple electrodes and an infrared sensor that are activated when the device is held between the thumb and forefinger and held up to the temple. Blood pressure and blood oxygen level data do not require cuff or finger clip devices, but are instead measured in this manner. The vital sign data is sent wirelessly to a smartphone app after a 10-second collection period.

"As more wireless health sensors become available to consumers, it is critical that these technologies undergo independent, scientific testing to validate their effectiveness and value," Dr. Eric Topol, director of STSI and chief academic officer of Scripps Health, said in a statement. "This study fully reflects the institute's mission of clinical validation of promising digital technology before it goes into mainstream medicine."

- here is the announcement