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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Tamas
Hickish
tamas.hickish@iQHealthTech.com
Sarah
Savage
sarah.savage@uhd.nhs.uk
More information about this study, what is involved and how to take part can be found on the study website.
Diabetes mellitus
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Device;
You can take part if:
You may not be able to take part if:
1. Un-willing or un-able to provide free informed consent; 2. Un-willing or un-able to comply with all protocol requirements including study assessments; 3. Bilateral foot ulcers
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Sarah
Savage
sarah.savage@uhd.nhs.uk
Tamas
Hickish
tamas.hickish@iQHealthTech.com
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by UNIVERSITY HOSPITALS DORSET NHS FOUNDATION TRUST and funded by NIHR Central Commissioning Facility (CCF) .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 55049
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
