Introduction: Diabetic foot ulcers (DFU) are a devastating complication of diabetes. There are numerous challenges with preventing diabetic foot complications and barriers to achieving the care processes suggested in established foot care guidelines. Multi-faceted digital health solutions, which combine multimodal sensing, patient-facing biofeedback, and remote patient monitoring (RPM), show promise in improving our ability to understand, prevent, and manage DFUs. Methods: Patients with a history of diabetic plantar foot ulcers were enrolled in a prospective cohort study and equipped with custom sensory insoles to track plantar pressure, plantar temperature, step count, and adherence data. Sensory insole data enabled patient-facing biofeedback to cue active plantar offloading in response to sustained high plantar pressures, and RPM assessments in response to data trends of concern in plantar pressure, plantar temperature, or sensory insole adherence. Three non-consecutive case participants that ultimately presented with pre-ulcerative lesions (a callus and/or erythematous area on the plantar surface of the foot) during the study were selected for this case series. Results: Across three illustrative patients, continuous plantar pressure monitoring demonstrated promise for empowering both the patient and provider with information for data-driven management of pressure offloading treatments. Conclusion: Multi-faceted digital health solutions can naturally enable and reinforce the integrative foot care guidelines. Multi-modal sensing across multiple physiologic domains supports the monitoring of foot health at various stages along the DFU pathogenesis pathway. Furthermore, digital health solutions equipped with remote patient monitoring unlock new opportunities for personalizing treatments, providing periodic self-care reinforcement, and encouraging patient engagement—key tools for improving patient adherence to their diabetic foot care plan.

Diabetes and its complications, particularly diabetic foot ulcers (DFUs), pose significant challenges to healthcare systems worldwide. DFUs result in severe consequences such as amputation, increased mortality rates, reduced mobility, and substantial healthcare costs. The majority of DFUs are preventable and treatable through early detection. Sensor-based remote patient monitoring (RPM) has been proposed as a possible solution to overcome limitations, and enhance the effectiveness, of existing foot care best practices. However, there are limited frameworks available on how to approach and act on data collected through sensor-based RPM in DFU prevention. This perspective article offers insights from deploying sensor-based RPM through digital DFU prevention regimens. We summarize the data domains and technical architecture that characterize existing commercially available solutions. We then highlight key elements for effective RPM integration based on these new data domains, including appropriate patient selection and the need for detailed clinical assessments to contextualize sensor data. Guidance on establishing escalation pathways for remotely monitored at-risk patients and the importance of predictive system management is provided. DFU prevention RPM should be integrated into a comprehensive disease management strategy to mitigate foot health concerns, reduce activity-associated risks, and thereby seek to be synergistic with other components of diabetes disease management. This integrated approach has the potential to enhance disease management in diabetes, positively impacting foot health and the healthspan of patients living with diabetes.

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Diabetic foot ulcers (DFUs) are a life-changing complication of diabetes. There is increasing evidence that plantar temperature monitoring can reduce the incidence and recurrence of DFUs. Once daily foot temperature monitoring is the current guideline for identifying early signs of foot inflammation and DFUs. However, single readings of physiological signals are known to increase the risk of misdiagnosis when there are fluctuations of the signal throughout the day. Objective: The purpose of this study was to evaluate whether intra-day temperature asymmetry signals were stable or varied as a function of time in individuals at risk of DFU. Methods: Sixty-four participants with diabetes (mean age = 68 ± 13.8 years) were provided with multi-modal sensory insoles (Orpyx® Sensory Insoles) to monitor continuous temperature data at five plantar locations with a frequency of once/minute during a 90-day study window. 1,080 data days, 5400 contralateral temperature asymmetry signals, were included. The Augmented Dickey-Fuller test was used to determine whether the temperature asymmetry signals were stationary (stable) or non-stationary (time-varying). Results: The majority (82%) of temperature asymmetry signals were time-varying, with intra-day fluctuations potentially driven by physiological and environmental factors. Nearly half (44%) of time-varying signals included a mix of concerning (>2.2°C) and non-concerning (≤2.2°C) measurements, indicating the limitations of single measurements in reliably identifying DFU risk. Statistical analysis revealed significant variability in stable versus time-varying patterns both within and across participants. Notably, days with time-varying signals and concerning asymmetry measurements showed dispersion of concerning periods across participants, time windows and days, rather than consistent daily patterns. Conclusions: Continuous monitoring could provide deeper insights into plantar temperature dynamics, uncovering associations with individual-specific factors such as vascular status, historical ulcer locations, activity, gait, and foot anatomy. These findings support the need for personalized monitoring protocols and leveraging continuous data to better inform clinical decision-making.