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Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device in Adults With Diabetes
Sponsor: Diabetis JSC
Summary
Single-center, prospective, minimal-risk, non-experimental usability study assessing the setup and use of the FDA-registered (Class I medical device; 510(k)-exempt) Feetsee™ home foot-monitoring system by adults with diabetes in their home environment over 8 weeks. This study in non clinical, observational pilot usability study conducted under FDA Human Factors and Usability Engineering guidance (2016).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
20
Start Date
2026-07-10
Completion Date
2027-07-10
Last Updated
2026-06-24
Healthy Volunteers
No
Conditions
Interventions
Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device
: after initial training, participants set up and use the Feetsee foot-monitoring system in their own homes, following the US IFU and in-app instructions. Data will be collected via paper/electronic CRFs, patient questionnaires, and Feetsee device/app usage logs (exported to REDCap and secure sponsor databases).
Locations (1)
UT Health San Antonio
San Antonio, Texas, United States