Upperline Health

Foot ulcers often go undetected until severe, leading to costly complications and preventable amputations

Upperline Health specializes in remote patient monitoring for elderly patients, addressing critical health issues proactively. One significant challenge for the client was monitoring and managing foot ulcers among patients with diabetes. Late detection of foot ulcers often leads to severe complications, including amputation, which could have been avoided with early intervention.

Research indicated that a temperature difference of four degrees Fahrenheit between the same spot on the left and right foot could predict ulcer formation with ~90% accuracy. Existing solutions, like monitoring socks, had poor patient compliance due to their inconvenient design.

Upperline proposed developing a shoe insole that could monitor foot temperatures, bypassing the shortcomings of monitoring socks and providing a seamless user experience. However, this posed significant technical challenges, including the ability to independently measure temperatures at seven specific points on the foot while ensuring the system operated without patient interaction or reliance on mobile apps and Wi-Fi. The solution also needed six months of battery life and HIPAA-compliant data transmission.

Designing advanced IOT for elderly patients

Preventing Compliance Issues by Understanding the Users’ Context

​​Especially since existing solutions had issues with patient compliance, we needed to ensure our design met the users where they were. We started by researching their current experience in-depth: understanding their living arrangements, where they typically store shoes, their daily routines, and whether the product needed to function while they were on vacation or in nursing facilities. We also explored factors like how frequently they wore shoes indoors versus outdoors and their ability to manage simple tasks like charging a device or following setup instructions. This detailed understanding allowed us to ensure the product would integrate seamlessly into their lives.

The research led us toward a plug-and-play system that avoided mobile apps and Wi-Fi setups. The system needed to function seamlessly across living environments, from private homes to nursing facilities, ensuring ease of use and reliability.

Validating our Approach through Rapid Prototyping

The Ovyl team began by testing the feasibility of placing temperature sensors in an insole capable of detecting precise measurements at multiple locations on the foot. Using a proof-of-concept prototype, the team created a silicone foot model with heating elements at seven distinct spots to simulate temperature changes. The team then dressed the foot in a sock and validated the temperature detection accuracy. 

These tests validated the solution's technical feasibility, allowing us to move forward confidently with detailed engineering and design.

Tacking Specific Technical Challenges

1. Sensor Integration: Ovyl designed small, coin-cell-powered sensor boards embedded within the insoles to monitor specific foot regions.
2. Data Transmission: The team developed a gateway device featuring a Nordic NRF52832 central unit paired with a cellular modem. This gateway collected data from the insoles via Bluetooth and transmitted it to the cloud using the MQTT protocol.
3. Battery Life: Ovyl optimized the sensors and communication systems to ensure a six-month battery life, ensuring minimal interaction and maintenance for patients and clinics.

HIPAA Compliance: Ovyl ensured all data transmission adhered to strict HIPAA regulations, safeguarding patient information.

Remote Monitoring Made Simple

The final system included:

• Custom insoles that could work with any shoe: Embedded with temperature sensors capable of independently monitoring seven points on each foot, even through socks.
• Plug-In Gateway Device: A cellular- and Bluetooth-enabled device that seamlessly transmits data to the cloud without user intervention and could function in private residences and nursing facilities. The gateway managed data from multiple users simultaneously, ensuring reliability and accuracy even in crowded settings.
• Web Application: A HIPAA-compliant platform for medical providers to view patient data, receive alerts, and take immediate action when temperature changes indicate potential ulcer formation.

This innovative solution enabled Upperline Health to monitor patients remotely without burdening them with complex technology. It significantly improved early detection of foot ulcers, reducing the need for amputations and enhancing patient outcomes. By addressing technical and usability challenges, Ovyl delivered a comprehensive system that blends cutting-edge IoT technology with compassionate healthcare solutions.

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