None listed
Conditions
Brief summary
This research project will test a new technology called the "Smart Footprint System" and aims to help people, with diabetes, to understand if they have differing foot temperatures to help with foot care. People with diabetes are at high risk of foot wounds, called ulcerations. This new technology can check foot temperature by standing on a mat called the "Smart Footprint" and then sending this information to an App, the "Smart Footprint" App. The mat measures skin temperature on both feet to see if there is a temperature difference between the two feet. If there is, it could mean an ulcer is forming. The aim of this research is to understand if people are willing and able to use the "Smart Footprint System" in their home and also, what worked well and what was challenging when using the system. Research participants need to be 18 or older with either type 1 or type 2 diabetes and with a diagnosis of peripheral neuropathy. For this study 12 participants will be recruited and these will come from two sites, one metro and one regional. This project will measure data from the system but also collect interview data from individuals. It is hoped that this project can show if this system works for people using it in their own home.
Interventions
The interventional device is a novel engineering solution designed to monitor foot temperature non-invasively through a mat, called the Smart Footprint. The device measures skin temperature on both feet using sensors and integrated circuits, that then process data to alert the user.
This study will use an explanatory sequential quantitative dominant (QUANT-qual) open label, single-group mixed-methods design. This study combines quantitative analysis of device performance and key participant-rela
The interventional device is a novel engineering solution designed to monitor foot temperature non-invasively through a mat, called the Smart Footprint. The device measures skin temperature on both feet using sensors and integrated circuits, that then process data to alert the user. This study will use an explanatory sequential quantitative dominant (QUANT-qual) open label, single-group mixed-methods design. This study combines quantitative analysis of device performance and key participant-related information such as intention to use technology and self-care behaviour history with individual interviews exploring the experiences of participants when using the device at multiple sites around Australia. As an overview participants will be involved in the following: -Provide consent: 30 minutes -Provide baseline data and assessment: 15 minutes -Filling in the first questionnaire: 15 minutes -Learning how to use the device: 30 minutes -Using the mat twice a day for 12 weeks: 5 minutes per day (total 420 minutes) -Final appointment after study: 30 minutes. -Final Interview: 60 minutes After consent is provided and baseline data collected (though a face-to-face assessment), participants will then be given a demonstration by the research assistant of how to use the device along with support to download the accompanying app (the Smart Footprint System). Based on the shoe size provided from the research assistant, the device will be configured to suit the individual and will be posted to the participant within two weeks of receiving consent and shoe size. When participants receive the device, the study begins from their first use of the device and will continue for a period of 12 weeks. Participants will have the ability to monitor their personal data on their app during the 12-week period, set-up notifications and reminders. Data from the app and prototype device will be uploaded to cloud storage where participation will be monitored by a CSIRO researcher monthly to ensure data fidelity and encourage adherence The digital research team (monitoring the temperature and app data) will contact participants once in the first week of the study, then halfway through the study and finally at the conclusion of the study. These calls are an opportunity to reiterate how to use the device (including sanitisation) in addition to reminding participants to maintain standard clinical care practices. Participants will be emailed with an alert if no data has been received from the prototype in seven days, and then again after ten days. Also, after not receiving data for seven days, the mobile app will provide a notification once a day as a reminder to use the device. A hotspot is detected from the prototype when last 2 consecutive readings of a threshold above or equal to 2.2 degrees with a minimum of 12 hours apart. If the prototype device detects a hot spot, participants will be provided with a notification from the device and mobile app and are instructed to follow the protocol of their standard clinical care. The digital research team (CSIRO) will also be alerted of “hot spots” and will contact participants via SMS and will also inform the clinical research site that will follow their clinical response pathway. On completion of the 12-week period, participants will be asked to attend the clinical site to return the device and complete two questionnaires to evaluate acceptance and usability. Participants will also undergo a skin integrity check completed by the clinical team, done face-to-face. Within a fortnight of finishing data collection, individual participant interviews (conducted by CSIRO through a phone number or online call through Microsoft Teams) will also be conducted to enable participants to provide context to the quantitative data (including mobile app analytics) and to provide an opportunity to explore their overall user experience. A CSIRO researcher will be available for technical support through phone/email once the participant receives the device (during work hours and weekdays). Participants will be offered a $100 gift voucher as a reimbursement of their time in the study. The vouchers are to be issued once the participant has completed the study, which will be at the post-study interview.
Sponsors
CSIRO
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
i. Age is 18 years and over. ii. Diagnosis of Type 1 or Type 2 Diabetes. iii. Peripheral neuropathy as determined by 10g monofilament and/or 128Hz graduated tuning fork. iv. Willing to use prototype device and smartphone app. Participants must have a compatible iOS or Android smartphone with Bluetooth and Internet Connection either through cellular network or WiFi home connection. v. No foreseeable extended travel away from home for the duration of study (no more than 4 cumulative weeks during the 3-month study period). vi. Capable of donning and doffing shoes independently. vii. An ability to carry and return mat device (3kg) to clinic.
Exclusion criteria
i. Active foot ulcerations or any foot ulcerations in the four weeks. ii. Previous transmetatarsal or more proximal foot amputations (must have two feet). iii. Cognitive or physical impairment that limits use of a smart footprint prototype device and smartphone app (as determined by clinical site). iv. Peripheral arterial disease with an Absolute Toe Pressure <60mmHg. v. Weighing over 135kg as per the mat’s manufacturer’s instruction. vi. A history of active or previous Charcot Neuropathy. vii. Allergy to Zinc Oxide viii. Shoe size greater than Australian Men’s Size 11 or Women’s Size 13.
Outcome results
None listed