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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).
Participants will be recruited from outpatient diabetes and podiatry clinics at UT Health San Antonio, an academic medical center. The study itself is conducted as a home-use usability study: 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 or Type 2 diabetes, recruited from outpatient clinics | Approximately 20 adults (≥18 years) with Type 1 or Type 2 diabetes, recruited from outpatient clinics at UT Health San Antonio |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Usability of the Feetsee Foot Monitoring System | • To evaluate the usability of the Feetsee Foot Monitoring System by both patients and healthcare providers when they use only the provided labeling, Quick Start Guide, Instructions for Use (IFU), and in-app instructions | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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This study will enroll adult participants with diabetes who are at risk for diabetic foot complications and who are able to use a smartphone-based home monitoring system. Participants represent the intended user population of the Feetsee™ Foot Monitoring System.
Participants will be recruited from diabetes, endocrinology, and podiatry clinics at UT Health San Antonio and affiliated University Health clinical sites under the supervision of the Principal Investigator.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helena Grinberg, PhD | Contact | +31615636666 | lenagrin@gmail.com | |
| Rytis Zajančkauskas, MD | Contact | rytis@diabetis.lt |
| Name | Affiliation | Role |
|---|---|---|
| Lawrence A. Lavery, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Health San Antonio | San Antonio | Texas | 78229 | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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