Addressing the Unmet Need in DiabeticNeuropathy: Insights from Experts andPatients on the Sensetic Device
Dynamis MedTech is advancing research into painful diabetic peripheral neuropathy (pDPN) with the Sensetic device, an innovative nonpharmacological treatment designed for patients who cannot tolerate or have exhausted standard therapeutics. The device delivers targeted electrical impulses intended to relieve symptoms to help patients regain quality of life.
Working with the NIHR HRC-DDR to conduct a preliminary expert review and a Public and Patient Involvement and Engagement (PPIE) session has been instrumental in consolidating and focusing the next steps of device innovation.
Unmet Need
pDPN is a debilitating diabetic complication, causing persistent burning or stabbing sensations, often in the feet (NICE, 2022). Of 589 million people with diabetes worldwide, about 147 million have pDPN, yet current treatments like duloxetine, pregabalin and TENS relieve pain in only half of diagnosed patients; leaving 74 million still affected (IDF Diabetes Atlas, 2025).
The Solution
The Sensetic device is designed to provide sustained pain relief for pDPN patients, potentially
improving sleep and overall well-being. Unlike many in-clinic treatments, the device is designed to be
used at-home, eliminating the need for daily hospital visits. The device’s core value proposition lies in
its promise of long-term relief – “10 days of treatment delivers 3 months of pain relief.” This would be
a major breakthrough compared to existing devices which only provide “in-the-moment” relief.
NIHR HRC-DDR Collaboration
The NIHR HRC-DDR has supported this project from its inception, guiding its development and
ensuring a patient-centric approach. This support was key in the delivery of a preliminary expert review
and PPIE sessions, providing valuable insights into the unmet need of the device and potential
challenges for consideration.
Expert Review Outcomes:
There is a clear critical unmet need, while highlighting the importance of demonstrating
a clear advantage over existing technology/therapeutics. There is a need to address practical factors such as cost, funding, maintenance and athome
usability.
Participants agreed the Sensetic device offers a promising non-drug, at-home alternative
for those with limited treatment options potentially improving patient quality of life.
PPIE Outcomes:
Patients valued the convenience of using devices at home, reducing the need for hospital visits, and expressed interest in understanding more about the research and usability of the device (e.g., how easy it is to press the buttons).
It was suggested that providing video instructions, alongside standard written materials, would better support to patients in learning to use the device independently.
Feedback Implementation
The expert review and PPIE feedback has been vital in shaping a clear path forward for the Sensetic
device. It confirmed the unmet need and validated the appeal of a non-pharmacological, at-home
treatment. Based upon the findings, the project team are now focused on:
Gathering robust clinical data: The feedback highlighted the critical need for evidence to support
the device’s claims, particularly the promise of long-term relief. This has solidified the decision to
prioritise and accelerate clinical trials to generate the necessary data.
Differentiation from existing devices: The panel’s concerns about how the Sensetic device
compares to TENS units have prompted a renewed focus on clearly demonstrating its added value.
Ongoing feedback from experts and patients continues to inform the development of a clearer
narrative and the need of data to highlight these differences.
Addressing usability and logistical concerns: The practical feedback on cost, maintenance and ease
of use (e.g., battery type, bulkiness) is directly informing the device’s final design and business
model. The team is exploring different power source options, engaging with healthcare system
administrators to understand potential funding and maintenance pathways, and planning future
usability studies to ensure the device meets patient needs in real-world settings.
Formative Usability Studies:
Early-stage testing with patients and clinicians to gather real-world
feedback on comfort, usability and functionality, feeding into design
refinements.
Summative Usability Study:
Comprehensive assessment of the finalised design to ensure it meets all user, regulatory and safety requirements before clinical rollout.
First-in-human clinical investigation:
Preparation to conduct a randomised controlled trial to generate robust clinical data proving the device’s effectiveness and long-term benefits compared to existing treatments.
Cost Analysis:
Develop a financial model outlining cost, maintenance and replacement plans to support
engagement with healthcare commissioning groups and demonstrate value.
Device Refinement:
Refine to be more user-friendly, comfortable and practical for at-home use. This includes selecting a reliable, easyto- manage power source and streamlining training for patients and clinicians.
HRC-DDR Collaboration – Next Steps
Building on the insights from PPIE session and expert review panel, the project will now focus on
targeted work packages to support device development and adoption. The application of an
upcoming NIHR I4i Product Development Award will enable a continued collaboration with the HRCDDR
and, if successful, will deliver the following work packages:
References
- National Institute for Health and Care Excellence (NICE). (2022). Diabetic foot problems: prevention and management (NICE guideline NG19). Available at: https://www.nice.org.uk/guidance/ng19 [Accessed 7 May 2025].
- IDF Diabetes Atlas. (2025). 11th Edition ed. [online] Belgium: International Diabetes Federation. Available at: diabetesatlas.org [Accessed 15 May 2025].
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