Mobile Biosensor for Measuring Vital Signs in Healthcare and Home Settings

This study will record vital signs (heart rate and blood oxygen levels) using a new cell phone integrated biosensor and compare it to routine measurements carried out in the clinics and hospital at UCSD. Cell phones will be given to a selected group of subjects for use at home and data collected.

Study Overview

• Status: Recruiting
• Conditions: Pulse Oximetry

Detailed Description

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:

Based on the results from phase 1a, one of the prototypes will be selected for further testing (the one with the least within-instrument variation). During Phase 1b, vital sign readings will be collected with the selected Maxim biosensor prototype and one of the Welch-Allyn Spot Vital Signs monitor simultaneously. The subjects will be recruited from both outpatient and hospital settings for accuracy and usability. A total of 550 subjects (500 adults and 50 adolescents) will be recruited for this part of phase 1.

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

• Study Contact: Name: Sara H Browne, MD MPH; Phone Number: 619 543 8080; Email: shbrowne@health.ucsd.edu
• Study Contact Backup: Name: Bianca Ramirez; Phone Number: +1-619-543 8080; Email: biramirez@health.ucsd.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • Recruiting
      • UCSD Antiviral Research Center
      • Contact: Sara H Browne, MD MPH; Phone Number: 858-822-6563; Email: shbrowne@ucsd.edu
      • Contact: Amanda J Tucker Maytom, MD; Phone Number: 6195433145; Email: a1tucker@ucsd.edu
      • Principal Investigator: Sara H Browne, MD MPH
      • Principal Investigator: Constance A Benson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children (≥ 13 years old) and adult male and female subjects who provide written informed consent and assent.

Description

Inclusion Criteria:

1. Children (≥ 13 years old) and adult male and female subjects who provide written informed consent and assent.
2. Subjects must be willing to use the mobile device and answer questions regarding their experience.

Exclusion Criteria:

Individuals with prior or recent injury to one or both of their index fingers that would prevent or interfere with the use of Maxim biosensor.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of vital signs (HR and SpO2)	The accuracy of the vital sign (HR and SpO2) readings collected by Maxim biosensor compared to standard of care Welch-Allyn Spot Vital Sign monitor.	20 minutes

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Sara H Browne, MD MPH, UC San Diego

Publications and helpful links

General Publications

• Browne SH, Bernstein M, Pan SC, Gonzalez Garcia J, Easson CA, Huang CC, Vaida F. Smartphone Biosensor With App Meets FDA/ISO Standards for Clinical Pulse Oximetry and Can Be Reliably Used by a Wide Range of Patients. Chest. 2021 Feb;159(2):724-732. doi: 10.1016/j.chest.2020.08.2104. Epub 2020 Sep 11.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2016
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 161573

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No