Mobile Biosensor for Measuring Vital Signs in Healthcare and Home Settings

Maxim Vital Sign study is a 2 part, investigator initiated observational study with Maxim Integrated aimed to compare vital sign readings using 2 prototype versions of new cell phone based mobile biosensors with standard of care (SOC). Adult subjects will be recruited from UCSD outpatient clinics, AVRC clinic, emergency department (ED), and hospitals. Vital signs will be measured using cell phone based mobile biosensors and SOC.

For Phase 1, up to 800 subjects will be recruited (700 adults and up to 100 adolescents). 250 subjects (200 adults and up to 50 adolescents) will participate in phase 1a and 550 subjects (500 adults and up to 50 adolescents) will participate in phase 1b. An additional group of 30 adult subjects will be recruited from outpatient clinics for participation in phase 2.

Phase 1a:

Two identical copies of the device will be tested during the first part of phase 1 with a total of 125 subjects (100 adults and up to 25 adolescents). Each prototype version will be tested on up to 125 subjects (100 adults and 25 adolescents) and compared to readings obtained by Welch-Allyn Spot Vital Signs monitor. Data will be obtained on the usability and accuracy of the measurements with each initial prototype. Measurement particularly of SpO2 depends on accurate finger position. Current SpO2 monitors encase the finger and immobilize it in order to obtain an accurate measurement. Maxim Integrated, in collaboration with DD Studios, Carlsbad CA, and Specialists in Global Health, Encinitas CA, have developed prototypes, which will be tested to inform design flaws in future prototypes.

Phase 1b: