The UK’s National Institute for Health and Care Excellence (NICE) has commenced a consultation on its draft medical technology guidance on a device which aims to diagnose nerve damage that is caused by diabetes.
Damage to the peripheral nerves can cause numbness and tingling in the feet and hands, shooting pains, muscle weakness and loss of co-ordination in the affected body parts. The nerve damage can mean that injuries like cuts are unnoticed and can develop into a diabetic foot ulcer. There is a risk that if the ulcer becomes infected that the foot tissue may die, and the foot might have to be amputated. Diabetes is the most common cause of peripheral neuropathy in England, as the high blood sugar levels associated with diabetes can damage the nerves. In the UK, over 2 million people with diabetes are at risk of nerve damage.
To test for loss of sensation in the foot of a person with diabetes, standard practice involves checking if the person can detect either a vibration (from a tuning fork) or light pressure (using a 10g monofilament) on their foot. VibraTip seeks to add a little standardisation to this test. It looks like a small key ring fob and provides a consistent, near-silent vibration. The device probe is held against the patient’s foot twice: once while not vibrating and once while vibrating. The patient is asked to say when they can feel the vibration. If the patient can’t feel the vibration further investigation may be needed.
The device manufacturer claims that the benefits of VibraTip include the test being easy, speedy and reliable to use, more consistent than a tuning fork test, more portable and easy to clean.
The draft medical technology guidance recognises that VibraTip shows potential to improve the diagnosis of diabetic peripheral neuropathy and to provide savings – but there currently isn’t enough evidence on its clinical effectiveness to support a case for routine adoption in the NHS, hence this consultation, which closes on August 6th.
The draft guidance provisionally recommends that research is carried out to address uncertainties in the potential benefits to patients and the NHS. This would include assessing the diagnostic accuracy of VibraTip, and the costs involved, compared with standard methods of diagnosing the condition.
More information on the medical technology draft guidance consultation for VibraTip is available here.
Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “Diabetes affects an estimated 3.75 million people in the UK, and around 60% of people with diabetes are susceptible to nerve damage caused by their condition.
“The Medical Technologies Advisory Committee thought that VibraTip shows promise in detecting diabetic nerve damage, so they have recommended that further research is carried out which will potentially allow definitive recommendations for clinical use to be made in the future. The case for routinely adopting the device in the NHS couldn’t be supported at this point as there isn’t enough evidence on its clinical effectiveness – but it is very important to note that this draft outcome doesn’t mean that the device should not be used. Part of these draft recommendations are that NICE proposes to review this guidance when new and substantive evidence becomes available.
“We look forward to receiving comments on our provisional recommendations from health professionals, industry and patient groups to help inform the development of this guidance on VibraTip.”