The National Institute for Health and Clinical Excellence has concluded there is insufficient evidence to support the routine use of a device for detecting diabetic peripheral neuropathy.
Final medical technology guidance has been published on VibraTip, which aims to diagnose nerve damage caused by diabetes.
The VibraTip device, manufactured by McCallan Medical, has a list price of £9.95, excluding VAT.
“Vibratip shows promise…although the case for routinely adopting the device in the NHS couldn’t be supported at this point as there isn’t enough evidence”
NICE said the device showed potential to improve the detection of diabetic peripheral neuropathy, but there currently was not enough evidence on its clinical and economic benefits to support a case for routine adoption in the NHS.
As a result, it has recommended that research is carried out to address uncertainties regarding the potential benefits to patients and the NHS.
This includes assessing the diagnostic accuracy of VibraTip, and the costs involved, compared with standard methods of diagnosing the condition.
NICE said it would update its guidance if and when “substantive new evidence becomes available”.
The standard method of vibration perception for testing diabetic peripheral neuropathy in the foot is to strike a calibrated tuning fork then hold it against the foot and ask the person if they can feel the vibration from the fork.
If the patient cannot feel the vibration further investigation may be needed. An alternative method for testing sensitivity is the 10g monofilament which detects light touch sensation.
VibraTip 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 cannot feel the vibration further investigation may be needed.
Professor Carole Longson, director of the NICE centre for health technology evaluation, said: “Although 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 benefits, it is very important to note that this guidance doesn’t mean that the device should not be used.
“NICE will update this guidance when substantive new evidence becomes available,” she added.