The NERVE Study
Research type
Research Study
Full title
NEuRopathy evaluation using the Vibration function of a mobile phonE
IRAS ID
322038
Contact name
Tamas Hickish
Contact email
Sponsor organisation
University Hospitals Dorset NHS Foundation Trust
Duration of Study in the UK
0 years, 3 months, 31 days
Research summary
There are approximately 4.7 million people in the UK living with diabetes. Diabetes can affect the functioning of the nerves, particularly in the hands and feet. This loss of sensitivity can mean that patients do not feel rubbing and pressure. If not treated properly this can lead to ulceration and for some patients this may progress and require amputation. Diabetes-related ulceration and amputation costs the NHS up to £1 billion a year, almost 1% of the total budget in England and can have a devastating impact on patients quality of life.
NICE guidelines (NG19) state that every person with diabetes should have an annual foot examination to determine their foot risk, however unfortunately in reality delivery of this is patchy. A potential solution is remote monitoring, this prompted the development of the NERVE device.
The NERVE study is a single centre validation study of the experimental NERVE device for the measurement of vibration perception threshold against the established ‘Neurothesiometer’ device, evaluating agreement and reliability. It will also include collecting feedback from patients, carers and clinicians on the usability of the device.
Anyone over 18 years of age who has been formally diagnosed with either type 1 or type 2 diabetes will be eligible to participate in the study. This will involve attending a single clinic visit that will last approximately one hour. During the clinic visit participants will undergo vibration perception threshold testing conducted by a healthcare professional using the experimental NERVE device and the standard Neurothesiometer. They will also conduct self-testing using the NERVE device and be provided an opportunity for a carer to conducted the test on them using the NERVE device if they would like. There are also the Mobile Phone Handset Ownership and Diabetes Digital Health Technology Usage and Usability questionnaires to complete.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
23/SC/0021
Date of REC Opinion
15 Mar 2023
REC opinion
Further Information Favourable Opinion