NICE consults on new device to detect diabetic nerve damage

Feedback sought on clinical benefits of VibraTip probe

Professor Andy Levy is the inventor of VibraTip

The detection of nerve damage caused by diabetes is set to improve with the launch of a consultation on a new type of test.

The National Institute for Health and Care Excellence (NICE) has opened a consultation on its draft medical technology guidance, which notes that VibraTip shows potential to improve the diagnosis of diabetic peripheral neuropathy and to provide savings.

However, there currently is not enough evidence on its clinical effectiveness to support a case for routine adoption across the NHS.

The draft guidance, therefore, provisionally recommends that research is carried out to address uncertainties in the potential benefits to patients and the NHS.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.

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 go unnoticed and can develop into an open sore on the foot – 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 two million people with diabetes are at risk of nerve damage.

The Medical Technologies Advisory Committee thought that VibraTip showed 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

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, which was invented by Andy Levy, a professor of neuroendocrinology at the University of Bristol and a consultant at University Hospitals Bristol NHS Foundation Trust, 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.

Levy claims the benefits include the test being easy, speedy and reliable to use, more consistent than a tuning fork test, more portable and easy to clean.

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 showed 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.

Part of these draft recommendations are that NICE proposes to review this guidance when new and substantive evidence becomes available

“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.”

The consultation closes on 6 August 2014.

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