Device and Data Access Considerations for Digital Health Studies Using Consumer-Grade Wearables: An Experience-Based...

Area of Science:

• Biomedical Engineering
• Clinical Research Technology
• Digital Health

Background:

• Consumer wearables like smartwatches and fitness trackers are increasingly accessible for health research.
• Their use in clinical trials presents challenges in device selection, data management, and participant support.
• Previous experience in large-scale clinical trials informs this practical guidance.

Purpose of the Study:

• To provide a structured framework for incorporating consumer wearables into clinical studies.
• To outline the consumer wearables market landscape and supporting data management software.
• To guide investigators in selecting appropriate devices and data tools based on study objectives.

Main Methods:

• Review of the consumer wearables market, including various form factors and manufacturers.
• Analysis of data management software solutions for wearable data.
• Delineation of key decision-making processes for study design involving wearables.

Main Results:

• Identification of major decision points in designing studies with consumer wearables.
• A structured framework for selecting wearable devices and data management tools.
• Insights into the engineering ecosystem required for successful wearable integration.

Conclusions:

• Consumer wearables can enhance clinical trials but require careful planning and execution.
• A systematic approach to device and data tool selection is crucial for study success.
• This tutorial offers practical guidance for researchers leveraging wearables in clinical research.