MANDARIN study
Research type
Research Study
Full title
Comparison of devices for the detection of diabetic neuropathy; an evaluative diagnostic study. (short title: ‘MANDARIN’ , Medipin Assessment for Neuropathy in Diabetes, A Real-world INvestigation)
IRAS ID
325532
Contact name
Stacey Fisher
Contact email
Sponsor organisation
North Cumbria Integrated Care NHS Foundation Trust
ISRCTN Number
ISRCTN85524728
Clinicaltrials.gov Identifier
MANDARIN1, MANDARIN study
Duration of Study in the UK
1 years, 0 months, 31 days
Research summary
Nerve damage and loss of protective sensation (LOPS) is a complication of diabetes. This diabetic neuropathy (DN) can subsequently lead to further complications such as diabetic foot ulcers and even amputation of toes and lower limbs. It is therefore essential to monitor for the development of DN in diabetic patients. In standard clinical practice DN is checked for using a monofilament, a piece of nylon on a stick that is pushed onto the patient’s foot; LOPS is the sign of DN having developed. Monofilament testing checks for damage to large nerve fibres. There is however evidence that small nerve fibres are damaged before the large nerves are affected. Using a practical, reliable, and simple tool to check for small nerve damage in a clinic setting may aid in detecting LOPS/DN earlier and optimising patient management. Medipin is a hygienic single-use device designed to check for small nerve fibre damage in feet. The main objective of this study is to determine how many patients have LOPS/DN when tested with the monofilament and Medipin device respectively and to what degree there is an overlap between the two tests. For this purpose a total of 139 patients will be assessed at a single clinic visit.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
23/WM/0095
Date of REC Opinion
25 Apr 2023
REC opinion
Further Information Favourable Opinion