Feasibility study assessing at-home infrared temperature monitoring
Research type
Research Study
Full title
A feasibility study assessing the impact of at-home infrared temperature monitoring (AITM) supported by telemedicine in the management of patients at high risk of diabetes related foot ulceration.
IRAS ID
312084
Contact name
Brian Kennon
Contact email
Sponsor organisation
NHS Greater Glasgow & Clyde
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
"Research Summary"
There is some evidence that before a diabetic foot ulcer (DFU) develops there are some changes in temperature indicating early damage to the tissues of the foot. This study aims to assess if using at home infra-red temperature monitoring (AITM) can detect this early damage and allow participants to make changes to prevent the development of (DFUs).
This is a feasibility study, designed to assess the acceptability of At Home Temperature Monitoring (AITM) by a patients at high risk of diabetes foot ulceration. The investigation hopes to identify any problems with the study design before progressing to a full-scale evaluation, and will assess the ease of use of the technology and if there are any barriers to using this.
Participants will be provided with an infrared camera and SMART phone and trained in how to use them. The participants will then be expected to capture images of both the plantar and dorsal aspects of their feet that will be sent to the research team for review. The two images will be captured once per day. The Intervention period will be 12 weeks.
If a raised temperature is identified, the participant will be offered a face to face review appointment where they will receive podiatry treatment (if required), ulcer prevention advice and more detailed thermal imaging.
Patient and health care professional questionnaires will be used at the start and end of the study period to assess quality of life impact and device ease of use.
"Summary of Results"
The study enrolled 11 participants (Cohort A: 8, Cohort B: 3), all classified as high risk of diabetes foot problems. There was a mean diabetes duration of 23 years and a mix of Type 1 and Type 2 diabetes. Baseline health metrics showed moderate glycaemic control (mean HbA1c 69.9 mmol/mol), preserved renal function (mean eGFR 53.4 ml/min/1.73m²), and no cardiovascular or cerebrovascular disease. Most participants were ambulatory using their own or bespoke footwear.Adherence to the imaging protocol declined over time, with only 45.5% attending the week 12 visit and just 9.1% completing the study. Common barriers included technical issues, lack of time, and loss of interest in device use. User feedback indicated the app was generally easy to access and visually appealing, but some found imaging difficult and required additional support. The most common reasons for not submitting images were:
o Lack of time (55.6% overall; 71.4% in Cohort A)
o Forgotten (33.3% overall)
o Camera issues (22.2% overall)
o No longer wishing to participate (22.2% overall)
o No longer wishing to use the device (33.3% overall)
o Image transfer issues (11.1% overall)
o Other reasons (33.3% overall)
A significant challenge for participants was taking images of the feet using the app with 40% reporting this as being difficult or very difficult. These reasons highlight both technical and motivational barriers.Image Quality
Only 1 participant (9.1%) had acceptable image quality on all submissions. The mean number of days with inadequate quality images was 10.8 (SD 7.9). The main reasons for inadequate quality were:
o Incomplete image capture (100% of those with poor quality)
o Out of focus (20%)
o Other reasons (30%)
The lack of good quality images presented problems with analysis. Despite additional support being provided to participants, the issue could not be fully resolved without significant changes being made to the application. This lead to early termination of the study.System Alerts and Clinical Actions
10 out of 11 participants (90.9%) received at least one temperature difference alert by week 4 with the mean number of alerts being 10.6 (SD 8.3). 4 out of 10 alerts (40%) were confirmed by the infrared (IR) cart device used in the diabetes foot clinic, and 5 out of 10 (50%) were agreed with by the podiatrist. All alerts led to a clinical action: 90% resulted in a telephone review, and 50% in a face-to-face review.
There was poor correlation between the participant devices, the IR cart and clinician judgement. This was deemed to be a result of image capture problems and was a significant factor in study termination.New Ulceration
Only 1 participant (9.1%) developed a new ulceration by week 4. They received early face to face review and appropriate podiatry care was implemented.Quality of life (EQ-5D-5L) scores were stable, with a slight decrease in health utility index at 12 weeks (mean change -0.1), and no major safety concerns were reported. Overall, while the technology was well-received by some, challenges with sustained engagement and technical usability highlight areas for improvement in future implementations.
Recommendations
Adherence: Early drop-off in image submission is notable, with technical (camera, transfer) and behavioural (time, forgetting, motivation) factors contributing.
Image Quality: Incomplete image capture is a major issue, suggesting a need for better user guidance or device design. These issues could not be resolved within the study timeframe and the study was terminated early to allow the manufacturer to make amendments to the device prior to resubmitting a further project Clinical Workflow: The system generated frequent alerts, most of which prompted clinical action, demonstrating the potential for early intervention but also the need to manage alert burden.
Safety: New ulceration was rare at this stage, but ongoing monitoring is essential. There is potential for daily thermography monitoring to highlight ulceration at an earlier stageREC name
Wales REC 7
REC reference
22/WA/0154
Date of REC Opinion
30 May 2022
REC opinion
Favourable Opinion