The guidance recognises that VibraTip shows potential to improve the detection of the nerve damage (diabetic peripheral neuropathy) and to provide savings – but there currently isn’t enough evidence on its clinical and economic benefits to support a case for routine adoption in the NHS. 

The guidance therefore 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.  NICE will update this guidance when substantive new evidence becomes available.

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 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.

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 looks like a small key ring fob and it 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.

Professor Carole Longson, director of the NICE centre for health technology evaluation, said: “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.

“The Medical Technologies Advisory Committee concluded 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. 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.”

ENDS

For more information call Dr Tonya Gillis at the NICE press office on 0300 323 0142, or out of hours on 07775 583 813.

Notes to Editors

About the NICE guidance

1. The medical technologies guidance, “VibraTip for testing vibration perception to detect diabetic peripheral neuropathy”, is available at http://www.nice.org.uk/guidance/mtg22.

2. VibraTip is manufactured by McCallan Medical.

3. The list price stated in the sponsor’s submission is £9.95 (excluding VAT) per device.

4. The peripheral nervous system covers three main groups of nerve systems. These are nerves that:
• control the body’s muscles to enable movement
• help regulate the body’s automatic functions such as bladder control
• allow the brain to register sensations such as pain, heat and cold.

5. 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 can’t feel the vibration further investigation may be needed. An alternative method for testing sensitivity is the 10 g monofilament which detects light touch sensation.

About the Medical Technologies Evaluation Programme

6. Established by NICE in 2009, the focus of this area of work is specifically on the evaluation of innovative medical technologies, including devices and diagnostics. The types of products which might be included are medical devices that deliver treatment such as those implanted during surgical procedures, technologies that give greater independence to patients, and diagnostic devices or tests used to detect or monitor medical conditions. The independent Medical Technology Advisory Committee has two core remits: selecting medical technologies for evaluation by NICE guidance programmes and also developing medical technologies guidance itself. The guidance applies to the NHS in England, and is not mandatory.
More information is available at http://www.nice.org.uk/MT.