| NCT ID | NCT06739135 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Manchester Metropolitan University |
| Condition | Diabetic Polyneuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 115 participants |
| Start Date | 2024-10-25 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 115 participants in total. It began in 2024-10-25 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a proof-of-concept randomised controlled trial (RCT). The goal of the study is to investigate the effectiveness of a feedback intervention to improve use of the accelerator pedal in patients driving with diabetes and peripheral neuropathy (DPN). The main (primary) question it aims to answer is: What is the effect of a visual feedback intervention (over 6 sessions a month apart), compared to no feedback, on accelerator pedal use by drivers with diabetic peripheral neuropathy? Our working hypothesis is that the visual feedback intervention will reduce the % of drive time with the accelerator pedal pushed down further than 9 degrees (about halfway down), the point at which the visual feedback (a warning signal) is triggered. Secondary research questions are: 1. What is the effect of the feedback intervention on drivers with diabetic peripheral neuropathy at the first visit, and at the third visit? When does the biggest improvement happen? Our working hypothesis is that the visual feedback intervention will reduce the % of drive time spent driving with the accelerator pedal pushed down further than 9 degrees, the point at which the feedback is triggered, in the first visit (ie with the first exposure to feedback) and by additional amounts in subsequent visits ie there will be an immediate benefit, and additional benefits that accrue gradually with repetition over the 6 monthly visits. 2. What is the effect of the feedback intervention on a second variable, % of drive time with the vehicle 'out of control'. Out of control is defined as extreme use of the steering wheel, large and rapid movements that reach the full range of motion of the steering wheel or large swings back and forth together with excursion out of lane which the driver fails to prevent. Our working hypothesis is that the visual feedback intervention will reduce the % of drive time with the vehicle out of control. Researchers will compare the group of drivers with neuropathy who receive the intervention with a control group who do not. In addition, a group of drivers who have diabetes but no diagnosed neuropathy will be studied. This is to seek confirmatory evidence (previously seen in a small sample in a previous study) that most drivers who have no diagnosed neuropathy do not push the accelerator pedal down more than 9 degrees and so do not need to improve their use of the accelerator pedal. Participants will have their driving assessed in a driving simulator. Participants with DPN who push the accelerator pedal down more than 9 degrees will then be randomly allocated to the intervention group or control group. Only drivers in the intervention group will go on to experience the visual feedback intervention (in 6 sessions a month apart). Drivers in the control group will have their driving assessed at their first visit, and then at two later visits timed to coincide with the 3rd and 6th visit by drivers in the intervention group. This is the minimum necessary to be able to compare their driving with the intervention group at the start, midpoint and end of the intervention.
Eligibility 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).
Contact & Investigator
Dilwyn Marple-Horvat, DPhil
PRINCIPAL INVESTIGATOR
Manchester Metropolitan University
Frequently Asked Questions
Who can join the NCT06739135 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 69 Years, studying Diabetic Polyneuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06739135 currently recruiting?
Yes, NCT06739135 is actively recruiting participants. Contact the research team at m.esselaar@mmu.ac.uk for enrollment information.
Where is the NCT06739135 trial being conducted?
This trial is being conducted at Manchester, United Kingdom.
Who is sponsoring the NCT06739135 clinical trial?
NCT06739135 is sponsored by Manchester Metropolitan University. The principal investigator is Dilwyn Marple-Horvat, DPhil at Manchester Metropolitan University. The trial plans to enroll 115 participants.