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Better Care Closer to Home: Enhancing Primary and Community Care
Sponsor: Universidad Complutense de Madrid
Summary
60 million people in Europe have diabetes (DM) and up to 34% (20.4 million) of them are at risk of developing diabetic foot ulcers (DFUs) in their lifetime (1). However, current primary and community care is suboptimal with 40% of DFUs recurring within a year. Path Active (PA) is a digital health tool composed of smart insoles and a Bluetooth-connected app, which remotely monitors users' DFU risk, reducing their reliance on institutionalised care. This project will use interdisciplinary approaches to assess PA's ability to strengthen primary and community care systems (Subtopic 1) in culturally and socioeconomically diverse settings. We will take an ecosystem approach, incorporating multiple stakeholders including end-user patients,healthcare professionals, policy makers and potential commercial partners, investigating PA through economic, social, and clinical lenses. The project will pilot PA in \>100 individuals across 3 different countries (Canada, Denmark, and Spain) over 18 months. This will allow us to carry out: * Implementation research: Mapping PA implementation in diverse care settings, identifying local barriers to PA's adoption and necessary changes to promote PA integration into community care. * Service and ICT research: End user-testing to facilitate iterative design improvements, ensuring PA is culturally appropriate. * Health economics and policy research: Investigate international policy impact on the health economics surrounding PA and inform PA's market plan for different health systems. * Pilots: Gather evidence on PA's effectiveness in preventing DFUs and investigate/tackle any potential efficacy differences between cultures. * Business development: Scale up PA production and map potential stakeholders in member sites. Overall, STRIDE-COM represents a significant step toward integrating innovative digital health solutions into primary care across Europe/Canada, establishing a replicable model for wearable technologies.
Official title: Smart Technology for Remote Intervention in Diabetic Foot ulcEr Prevention in COMmunity Settings
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2027-04-01
Completion Date
2030-12-20
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Path Active™, a smart insole system designed to reduce the risk of plantar ulceration in patients with diabetic foot disease
The investigational intervention is Path Active™, a smart insole system designed to reduce the risk of plantar ulceration in patients with diabetic foot disease by monitoring plantar temperature and plantar pressure patterns, and transmitting these data to a mobile application. Participants in both study arms will receive the Path Active™ insoles and the corresponding mobile application. The only difference between the study groups is whether the ulcer-risk alert functionality is enabled or disabled. In the intervention group, the system will generate alerts based on the assessed risk of developing plantar diabetic foot ulcers, whereas in the control group all ulcer-risk alerts will be disabled. All other device functionalities, including plantar pressure and temperature monitoring, will remain active in both groups.
Locations (3)
University of Quebec in Trois-Rivieres
Québec, Canada
Steno Diabetes Center
Aalborg, Denmark
Diabetic Foot Unit, Universidad Complutense Madrid
Madrid, Madrid, Spain