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Review
. 2021 Jan;55(1):33-37.
doi: 10.1007/s43441-020-00187-3. Epub 2020 Jun 25.

Determining Minimum Wear Time for Mobile Sensor Technology

Marie McCarthy  1 , Denise P Bury  2 , Bill Byrom  3 , Cindy Geoghegan  4 , Susan Wong  5
Affiliations
Review

Determining Minimum Wear Time for Mobile Sensor Technology

Marie McCarthy et al. Ther Innov Regul Sci. 2021 Jan.

Abstract

Part 1 in the DIA Study Endpoint Community Working Group on Mobile Sensor Technology (MST) series addresses considerations that may be useful when determining the minimum wear time associated with mobile sensor use to ensure reliable estimation of the clinical endpoint under consideration. What constitutes a minimum valid data set is a dilemma facing those using MSTs in clinical studies. If this alignment does not occur, the integrity of the data collected and conclusions drawn from these data may be in incorrect. While study participants should consent to engage with MSTs as defined in a protocol, participant behavior or technology lapses may result in capturing incomplete data. Drawing from the literature, we review what constitutes a minimum data set, the risks associated with missing data, alignment with the clinical endpoint(s) and goals of a study, as well as managing patient burden.

Keywords: Clinical trials; Digital health technologies; Minimum wear time; Mobile health; Sensors; Valid data set; Wearable devices.

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