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Determining Minimum Wear Time for Mobile Sensor Technology

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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.

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Funding

There were no funding sources. No financial support was received.

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Authors and Affiliations

  1. ICON PLC, South County Business Park, Leopardstown, Dublin 18, Ireland

    Marie McCarthy MSc, MBA

  2. Sanofi-Aventis Groupe (Sanofi), Cambridge, USA

    Denise P. Bury MPH, PhD

  3. Signant Health, London, England, UK

    Bill Byrom

  4. Patient and Partners LLC, Madison, CT, USA

    Cindy Geoghegan

  5. Transparency Life Sciences, Inc., Philadelphia, USA

    Susan Wong PA

Authors
  1. Marie McCarthy MSc, MBA
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  2. Denise P. Bury MPH, PhD
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  3. Bill Byrom
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  4. Cindy Geoghegan
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  5. Susan Wong PA
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Corresponding author

Correspondence to Marie McCarthy MSc, MBA.

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McCarthy, M., Bury, D.P., Byrom, B. et al. Determining Minimum Wear Time for Mobile Sensor Technology. Ther Innov Regul Sci 55, 33–37 (2021). https://doi.org/10.1007/s43441-020-00187-3

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  • DOI: https://doi.org/10.1007/s43441-020-00187-3

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