Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device in Adults With Diabetes

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).

Inclusion Criteria: * Males and females aged 18 years or older * Clinical diagnosis of Type 1 or Type 2 diabetes * At least one palpable foot pulse per feet * Possess basic ability to use a smartphone or tablet * Have no prior experience with the Feetsee™ system * Be willing and able to provide informed consent Exclusion Criteria: * Active foot ulceration at enrollment * Active Charcot neuro-osteoarthropathy * Severe vascular disease (complete absence of foot pulses) * Amputation of more than three toes * Active malignancy or immunosuppressive condition * Cognitive or physical impairments preventing proper device usage * Concurrent participation in another investigational study with contraindicated procedures