Improving driving safety for patients with diabetic neuropathy
Enabling People with Diabetic Neuropathy to Drive Safely: a Proof of Concept Randomised Controlled Trial
This study is testing a new visual feedback tool to help people with diabetic neuropathy drive more safely by improving how they use the accelerator pedal.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 115 (estimated) |
| Ages | 25 Years to 69 Years |
| Sex | All |
| Sponsor | Manchester Metropolitan University Academic / other |
| Locations | 1 site (Manchester) |
| Trial ID | NCT06739135 on ClinicalTrials.gov |
What this trial studies
This proof-of-concept randomized controlled trial investigates the effectiveness of a visual feedback intervention aimed at improving accelerator pedal use in drivers with diabetic peripheral neuropathy (DPN). Participants will undergo a baseline driving assessment in a simulator, after which those who exceed a specific accelerator pedal threshold will be randomly assigned to either an intervention group receiving visual feedback or a control group with minimal intervention. The study will assess changes in driving behavior over six sessions spaced a month apart, focusing on reducing the percentage of time the accelerator pedal is pushed down beyond a critical angle. The primary goal is to enhance driving safety for individuals with DPN.
Who should consider this trial
Good fit: Ideal candidates are individuals with type 2 diabetes and diabetic peripheral neuropathy who hold a full UK driving license and drive regularly.
Not a fit: Patients with active foot ulcers, significant lower limb amputations, or cognitive impairments such as dementia may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve driving safety for patients with diabetic neuropathy.
How similar studies have performed: While this approach is innovative, similar studies focusing on driving safety interventions for patients with chronic conditions have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to understand English and all of the study requirements, including ability to provide informed consent * Current full UK driving licence held, and for a minimum of 5 years (experienced drivers) * Drives a car at least once per week on average (current drivers) * Diagnosed with type 2 diabetes and diabetic peripheral neuropathy * Diagnosed with type 2 diabetes only (no diagnosed diabetic peripheral neuropathy) Exclusion Criteria: * Active foot ulcer on either foot * Lower limb amputation involving more than two toes on the right foot * Dementia * Current participation in another research study that would compromise safety, or scientific integrity of either study (for example, a pharmaceutical trial that may affect ability to drive safely).
Where this trial is running
Manchester
- Manchester Metropolitan University — Manchester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Dilwyn Marple-Horvat, DPhil — Manchester Metropolitan University
- Study coordinator: Maaike Esselaar, PhD
- Email: m.esselaar@mmu.ac.uk
- Phone: +44 787 310 9658
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.