NICE seeks more info on nerve damage detector


A medical device that is used to detect the early stages of nerve damage in diabetics has shown some signs of effectiveness, but not enough to warrant its routine use in the UK National Health Service (NHS), says the National Institute for Health and Care Excellence (NICE).

Draft medical technology guidance from the cost-effectiveness watchdog suggests that the VibraTip device from McCallan Medical does, however, show potential in improving the diagnosis of diabetic neuropathy and saving costs by helping to prevent serious complications such as diabetic foot ulcers and amputations.

As a result, NICE recommends that additional research is carried out to assess the 'diagnostic accuracy' of VibraTip, and the cost of the device compared to other diagnostic methods.

At the moment doctors check for nerve damage in diabetics by seeing whether they can detect vibration using a tuning fork or light pressure from a microfilament applied to the foot, but these require a degree of skill and experience to use properly and achieve an accurate assessment.

VibraTip costs around £10 and looks a little like a key fob. It has a battery life of several months. When activated the device emits a regular, almost silent vibration. Testing involves holding the device against the patient's foot twice - once while it is vibrating and once when it is switched off - to see if they can detect the difference. Vibration sense is typically one of the first sensations to become impaired as neuropathy takes hold.

While NICE is unable to back use of VibraTip at the moment, it has not ruled out NHS-wide adoption of the device with more data and stressed that the draft guidance "doesn't mean that the device should not be used," according to Professor Carole Longson, Director of the agency's Centre for Health Technology Evaluation (CHTE).

"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," she added.

At the moment some 3.75 million people in the UK have diabetes, and nearly two-thirds of them will develop diabetic nerve damage. Figures from medical charity Diabetes UK indicate that the country spends £10 billion a year on the disease, which swallows up around 10 per cent of the total NHS budget.

Moreover, Diabetes UK notes that late diagnosis and intervention means that more patients go on to develop complications such as neuropathy and kidney damage, which can lead to extended hospital stays and escalating costs. In fact, managing complications accounts for 80 per cent of the total spend, while a quarter goes towards hospital in-patient care.

Given that the burden of managing diabetic nerve damage in the NHS is already sizeable - and only expected to increase as the incidence of diabetes rises - the bar for proving VibraTip's worth may not be set too high.

The consultation period on the draft guidance on VibraTip ends on 6 August and NICE is due to deliver a final verdict after a meeting in mid-October.

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Linda Banks

9 July, 2014