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BACKGROUND Diabetic foot ulcers (DFUs) are a devastating complication of diabetes and a leading cause of non-traumatic foot amputations. Traditional methods of monitoring and managing patients with diabetes, such as periodic in-person clinic visits, may not be sufficient for preventing DFUs and amputations. Continuous Remote Temperature Monitoring has the potential to capture the critical period before the foot ulcers develop and to improve outcomes by providing real-time data and early interventions. For the first time, the effectiveness of such a strategy to prevent DFUs and amputations among high-risk patients in a real-world commercial setting is reported. OBJECTIVE The aim of this study is to evaluate the effectiveness of a real-world continuous remote temperature monitoring program in preventing DFUs and amputations in patients with diabetes. METHODS In this retrospective analysis of a real-world continuous remote temperature monitoring program, 109 high risk patients identified by clinical providers from 15 geographically diverse private podiatry offices were analyzed. Patients received continuous remote monitoring socks as part of the program. The enrollment was based on medical necessity as decided by their managing physician. We evaluated data from up to 2 years before enrollment and up to 3 years during the program. Primary outcome was the rate of wound development. Secondary outcomes included amputation rate, severity of the foot ulcers, and the number of visits to an outpatient podiatry clinic after enrolling in the program. RESULTS We observed significantly lower rates of foot ulceration (relative risk reduction (RRR) 0.69; number needed to treat (NNT) 5.0; 95% CI 0.80, 0.53; p CONCLUSIONS Our findings suggested that a real-world continuous remote temperature monitoring program was an effective strategy to prevent DFU development and non-traumatic foot amputation among high-risk patients. CLINICALTRIAL WCG-IRB (1284366)

Elizabeth Brooks,1 Megan Burns,1 Ran Ma,2 Henk Jan Scholten,2 Shawn Becker3 1TTi Health Research and Economics, Westminster, MD, USA; 2Siren Care, Inc, San Francisco, CA, USA; 3Silvercat Advisors, LLC, Burlingame, CA, USACorrespondence: Megan BurnsTTi Health Research and Economics, 1231 Tech Ct Suite 201, Westminster, MD, 21157, USAEmail meganalexburns@gmail.comBackground: Foot temperature monitoring for the prevention and early detection of diabetic foot ulcers (DFU) is evidence-based and recommended in clinical practice. However, easy-to-use remote monitoring tools have been lacking, thereby preventing widespread adoption.Objective: To evaluate the cost-effectiveness of remote foot temperature monitoring (RFTM) (Siren’s Neurofabric™ Diabetic socks) in addition to standard of care (SoC) versus SoC alone for early detection of DFU with diabetic neuropathy and a moderate to high risk of DFU.Methods: A payer perspective decision-tree analysis was conducted to compare expected DFU occurrence and subsequent amputation rates and costs between treatment strategies over one year. Inputs in the model were sourced from publicly available literature and relevant health technology assessments. One-way sensitivity analyses were performed for each model variable.Results: In the base-case scenario, RFTM plus SoC was a dominant strategy compared to SoC alone. RFTM plus SoC was associated with cost savings of $38,593 per additional ulcer avoided versus SoC alone, and $8027 per patient per year on average compared to SoC alone. These results were highly robust to one-way sensitivity analysis; all scenarios remained dominant if compliance was ≥ 13%.Conclusion: RFTM is a cost-effective addition to SoC in patients with diabetic neuropathy at a moderate-to-high risk of DFU and subsequent amputation. Further, reduction in DFU and associated complications may result in improvements in the patient’s quality of life and mental health. Future studies are needed to evaluate the compliance and reduction of DFU occurrence in patients on RFTM.Keywords: diabetes mellitus, diabetic foot, technology assessment, biomedical, cost-benefit analysis, cost savings, decision trees

BACKGROUND Remote patient monitoring (RPM) devices are increasingly being used in caring for patients to reduce risks of complications. Temperature monitoring specifically has been shown in previous studies to provide a useful signal of inflammation that may help prevent foot ulcers. OBJECTIVE In this cross-sectional study, we evaluated utilization data for patients who were prescribed smart socks as remote temperature monitoring devices. METHODS This study evaluated data from a patient registry from January to July 2021. The utilization data, which were collected starting from the first full month since patients were prescribed the smart socks, were evaluated along with retention over time, the average time that the socks were worn, and the number of days that the socks were worn per month and per week. RESULTS A total of 160 patients wore the smart sock RPM device for 22 to 25 days per month on average. The retention rate was 91.9% (147/160) at the end of the 7-month period; a total of 13 patients were lost to follow-up during this period. The average number of days that the socks were worn per week was 5.8. The percentage of patients with a utilization rate of >15 days ranged from 79.7% (106/133) to 91.9% (125/136) each month. CONCLUSIONS This study shows a high level of utilization for a smart sock RPM device and a high compliance rate. A future prospective study on the clinical outcomes after the use of the smart socks may further solidify the idea of conducting temperature monitoring for foot ulcer prevention.

Background Lower extremity complications of diabetes represent major health care complications both in terms of cost and impact to quality of life for patients with diabetic peripheral neuropathy. Temperature monitoring has been shown in previous studies to provide a useful signal of inflammation that may indicate the early presence of a foot injury. Objective In this study, we evaluated the temperature data for patients that presented with a diabetic foot injury while using a sock-based remote temperature monitoring device. Methods The study abstracted data from patients who were enrolled in a remote temperature monitoring program (2020-2021) using a smart sock (Siren Care). In the study cohort, a total of 5 participants with a diabetes-related lower extremity injury during the study period were identified. In the second comparison cohort, a total of 26 patients met the criteria for monitoring by the same methods but did not present with a diabetes-related podiatric lower extremity injury during the same period. The 15-day temperature differential between 6 defined locations on each foot was the primary outcome measure among subjects who presented with a diagnosed foot injury. Paired t tests were used to compare the differences between the two groups. Results A significant difference in temperature differential (temperature measured in °F) was observed in the group that presented with a podiatric injury over the course of evaluation versus the comparator group that did not present with a podiatric injury. The average difference from all 6 measured points was 1.4 °F between the injury group (mean 3.6, SD 3.0) and the comparator group (mean 2.2, SD 2.5, t=–71.4, df=39; P Conclusions The results of this study suggest temperature monitoring in a sock form factor could be used to predict a developing foot injury. The continuous temperature monitoring system employed has implications for further algorithm development to enable early detection. The study was limited by a nonrandomized, observational design with limited injuries present in the study period. We look forward to further studies that will refine the predictive potential and confirm or refute the current promising data.

BACKGROUND Lower extremity complications of diabetes represent major health care complications both in terms of cost and impact to quality of life for patients with diabetic peripheral neuropathy. Temperature monitoring has been shown in previous studies to provide a useful signal of inflammation that may indicate the early presence of a foot injury. OBJECTIVE In this study, we evaluated the temperature data for patients that presented with a diabetic foot injury while using a sock-based remote temperature monitoring device. METHODS The study abstracted data from patients who were enrolled in a remote temperature monitoring program (2020-2021) using a smart sock (Siren Care). In the study cohort, a total of 5 participants with a diabetes-related lower extremity injury during the study period were identified. In the second comparison cohort, a total of 26 patients met the criteria for monitoring by the same methods but did not present with a diabetes-related podiatric lower extremity injury during the same period. The 15-day temperature differential between 6 defined locations on each foot was the primary outcome measure among subjects who presented with a diagnosed foot injury. Paired t tests were used to compare the differences between the two groups. RESULTS A significant difference in temperature differential (temperature measured in °F) was observed in the group that presented with a podiatric injury over the course of evaluation versus the comparator group that did not present with a podiatric injury. The average difference from all 6 measured points was 1.4 °F between the injury group (mean 3.6, SD 3.0) and the comparator group (mean 2.2, SD 2.5, t=–71.4, df=39; P CONCLUSIONS The results of this study suggest temperature monitoring in a sock form factor could be used to predict a developing foot injury. The continuous temperature monitoring system employed has implications for further algorithm development to enable early detection. The study was limited by a nonrandomized, observational design with limited injuries present in the study period. We look forward to further studies that will refine the predictive potential and confirm or refute the current promising data.

BACKGROUND Over 30 million people in the United States (over 9%) have been diagnosed with diabetes. About 25% of people with diabetes will experience a diabetic foot ulcer (DFU) in their lifetime. Unresolved DFUs may lead to sepsis and are the leading cause of lower-limb amputations. DFU rates can be reduced by screening patients with diabetes to enable risk-based interventions. Skin temperature assessment has been shown to reduce the risk of foot ulceration. While several tools have been developed to measure plantar temperatures, they only measure temperature once a day or are designed for clinic use only. In this report, wireless sensor-embedded socks designed for daily wear are introduced, which perform continuous temperature monitoring of the feet of persons with diabetes in the home environment. Combined with a mobile app, this wearable device informs the wearer about temperature increases in one foot relative to the other, to facilitate early detection of ulcers and timely intervention. OBJECTIVE A pilot study was conducted to assess the accuracy of sensors used in daily wear socks, obtain user feedback on how comfortable sensor-embedded socks were for home use, and examine whether observed temperatures correlated with clinical observations. METHODS Temperature accuracy of sensors was assessed both prior to incorporation in the socks, as well as in the completed design. The measured temperatures were compared to the reference standard, a high-precision thermostatic water bath in the range 20°C-40°C. A total of 35 patients, 18 years of age and older, with diabetic peripheral neuropathy were enrolled in a single-site study conducted under an Institutional Review Board–approved protocol. This study evaluated the usability of the sensor-embedded socks and correlated the observed temperatures with clinical findings. RESULTS The temperatures measured by the stand-alone sensors were within 0.2°C of the reference standard. In the sensor-embedded socks, across multiple measurements for each of the six sensors, a high agreement (R2=1) between temperatures measured and the reference standard was observed. Patients reported that the socks were easy to use and comfortable, ranking them at a median score of 9 or 10 for comfort and ease of use on a 10-point scale. Case studies are presented showing that the temperature differences observed between the feet were consistent with clinical observations. CONCLUSIONS We report the first use of wireless continuous temperature monitoring for daily wear and home use in patients with diabetes and neuropathy. The wearers found the socks to be no different from standard socks. The temperature studies conducted show that the sensors used in the socks are reliable and accurate at detecting temperature and the findings matched clinical observations. Continuous temperature monitoring is a promising approach as an early warning system for foot ulcers, Charcot foot, and reulceration.

This paper presents the outlines of a new EU-fundedresearch program for the long-term history, present-daymanagement and further development of the Europeanlandscapes, including their natural and cultural heritage:HERCULES. One of the subprojects of this program(Work Package 2) links archaeological, historical andhistorical ecological data to the analysis of geo-informationin order to develop models of long-term landscape changein three carefully chosen study regions in the Netherlands,Sweden and Estonia. This is framed theoretically byintegrating insights from landscape biography, historicalecology and complex systems theory. The linking andanalysis of data will be done using a Spatial DataInfrastructure and by means of dynamic modelling.

The metropolitan landscape consists of green, open areas adjacent to and enclosed by the urban environment. Changes in this landscape are a delicate matter, because they affect sustainability, the environment and the scenic quality, as we see in processes like urban sprawl, intensive outdoor recreation, city expansion and additional investments in infrastructure. More precisely, changes in the supply of open space, both in absolute terms (acreage) and its accessibility are a major concern around metropolitan areas. The lack of a clear monetary value makes green, open areas vulnerable to construction activities and infrastructure. Such use of open space entails the imposition of externalities of certain actors on others, but since the market value of open space does not fully reflect the societal value of open space, these externalities are market failures that call for corrective measures by the public sector in the form of land use interventions or pricing measures. However, as it turns out, failure of the governmental correction impedes effective market co-ordination. Unfortunately, attempts to value open space are virtually non-existent to date. Partly because the valuation of severance and visual intrusion is hampered by many complications, especially difficulties in objective quantification, uncertainties on the impacts on human and ecological communities, and collinearity with other pressures on the metropolitan open space (for example noise disturbance from infrastructure). The development of a research method for the valuation of open space will therefore be an important objective of the project. Incorporation of the public interest in open space in metropolitan planning requires quantitative valuation of this asset. The difficulty with such a valuation is of course that environmental and general societal values are normally not traded on real world markets, and hence no market prices can be observed that would reflect or approximate marginal costs or benefits. An environmental-economic framework will be used to quantify the ecological, economic and societal values of open space in a coherent way. Two complementary methods will be used: revealed preference and stated preference valuation. As it will not be possible to estimate economic values for all different dimensions of open space, the program focuses on those aspects that can be related to the appreciation of individual residents of the metropolitan landscape. These are the so-called ‘use values’ that humans attach to open space on the basis of their own, direct interest. This focus means that for instance so-called ‘intrinsic’ environmental values (referring for example to habitat fragmentation and indirectly biodiversity) will be postponed to future research. The program will more specifically concentrate on the added value of the availability of open space on residential property and the valuation of cultural and recreational characteristics of open space by potential visitors.

The Netherlands is one of the most densely populated countries in the world and urban functions are constantly claiming more space. This continuing urbanisation has lead to a growing concern for the preservation of open space. A loss of open space does not only mean a fragmentation of ecosystems or (potential) animal habitat but also affects the geographical, historical and cultural qualities of the landscape. The preservation of open space is an important theme in the spatial planning of the Netherlands. The Dutch government strives to keep the total volume of open space at a reasonable high level and tries to avoid the fragmentation of open space. The present research deals with the modelling of future land use and will focus more specifically on the fragmentation of open space. A GIS-oriented land use model will be used to study this subject. Assessing the impact of land use change on open space calls for a thorough definition of open space that takes into account the shape and size characteristics of various land use functions. This definition is strongly related to the policy context that introduces the concept of open space. In the Dutch, anthropocentric practice open space does not necessarily refer to large natural areas with high ecological values, but it rather relates to large areas with relatively few buildings. This might for example exclude wooded areas that do not offer panoramic views. Single objects (high voltage or television masts) can also severely affect the individual experience of open space. GIS-technology allows for a quantitative implementation of the concept of open space. It furthermore facilitates the spatial analysis of the impact of land use changes. Different simulations from land use models will be assessed both in terms of a total loss in the volume of open space and the localised impact in terms of fragmentation. To study the latter impact a methodology will be developed that will adopt experiences from spatial ecological research on habitat fragmentation.