The investigator team will study the adherence of the participant cohort to a non significant risk device over a six month period. The device is a foot mat, which can detect changes in foot temperature that may predict foot ulceration in patients with diabetes mellitus. This mat, the Podimetrics Smart Mat, is FDA cleared.
Innovations toward the prevention of diabetic foot ulcer (DFU) are needed. Early detection of changes in the foot that predict the development of DFU could allow timely intervention to prevent the limb damage that occurs with advanced DFU. Studies have demonstrated that increased temperature in the foot presage the development of DFU. Temperature changes can accurately be detected by home monitoring devices and predict impending ulceration. Here the study team will test the uptake of novel foot temperature monitoring technology for a future intervention study to determine if a home monitoring device could prevent the occurrence of severe DFU for patients at Montefiore Medical Center (MMC). The investigator team will conduct a longitudinal study to determine the adherence to an FDA cleared device, Podimetrics, which has been tested in other populations and shown to 1) decrease the risk of severe DFU, and 2) decrease the utilization of health care resources in high risk patients with a history of DFU. For this study, the study team will identify and enroll patients who are at high risk for DFU. These participants will be identified from the electronic medical record (EMR) and have case report form filled out. After providing informed consent, study participants will receive the foot mat and obtain training remotely from Podimetrics, which provides a standardized training program. Participants briefly stand on the mat daily (20 seconds), and the temperature data is automatically sent for analysis to Podimetrics to interpret the information. The participants will be evaluated over a six-month period to measure: 1. Daily use of the technology 2. Secondary outcomes: occurrence of DFU and use of health care resources. Study participants will be contacted every month by the Einstein investigators to assess foot health. Study participants will be instructed to contact the study team during the study period to inquire if development of any changes in the foot such as the diagnosis of DFU, or if a foot cast is required for offloading, or if participants have any concerns about their feet.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
20
Participants receive training for stepping on SmartMat each day for 6 months. Monthly phone calls will be conducted to assess foot health and mat.
Montefiore Medical Center
The Bronx, New York, United States
Adherence to Use of SmartMat
Participant adherence to use of SmartMat will be quantified by automated data collection. Adherence is defined as having conducted \>3 days foot scans per week (foot scans/week) over the six-month period. The median number of scans/week over a six-month period is reported.
Time frame: Up to six months following intervention
Use of Health Care Facilities
Use of health care facilities will be enumerated based on the number of participants who presented for care over the course of the study. This will include patient visits to the Emergency Room (ER), podiatrist, internist, walk in clinic, and other health care facilities. This outcome will be based on participant self-reporting of visits. The total number of participants who visited a health care facility is summarized.
Time frame: Up to six months following intervention
Occurrence of Diabetic Foot Ulcer (DFU)
The number of participants who developed DFU during the course of the study is summarized. Diagnosis of DFU was be based on a physical exam.
Time frame: Up to six months following intervention
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