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.
Lay summary of study results:
What was the research study that I was involved in?
The research study was called the MANDARIN study (Medipin Assessment for Neuropathy in Diabetes, A Real-world Investigation). The aim of the study was to find out if a pin-prick device called Medipin is useful to identify if a patient has (signs of) diabetes-related neuropathy. The symptoms of this condition are reduced or no sensation to the foot being touched, and in some cases foot pain without being touched. The standard test in GP practices in the NHS is the use of a so-called monofilament; this device only applies gentle pressure to the foot and is not a sharp pin-prick method. In the past the pin-prick was used, but with unhygienic and unsafe tools such as a blackboard pin or a needle.
In the last year, we invited patients with type two diabetes and results were obtained for 399 patients in North Cumbria. Because of insufficient numbers, we could not evaluate results for a few control and type one diabetes patients.
What did we find?
There are three main things we found out:
1. Both the Medipin pin-prick and monofilament device can detect neuropathy. There is a considerable similarity in terms of the patients they identify neuropathy in. Apart from diabetes itself, only patient height was the other factor linked to higher chance of having (early signs of) neuropathy. Patient sex, age, or any heart/diabetes medication taken, were not linked to the test outcomes.
2. Of the two monofilament tests done on each patient, the one testing just the large toe is more effective than the one where the soles of the feet are tested.
3. (Early signs of) Neuropathy are picked up more often with Medipin pin-prick compared to monofilament testing.
Medipin: 59% of patients had no signs of neuropathy (sharp sensation),
38% of patients had impaired sensation (dull sensation), 3% of patients had complete neuropathy (no sensation at all).
For the best monofilament method, the figures were 79% no neuropathy, 14% elevated risk, and 7% neuropathy respectively.
In conclusion, the Medipin pin-prick test appears to detect (early signs) of diabetic neuropathy sooner than the currently used monofilament device. This may be explained by the types of nerves that each device targets. Medipin mainly tests for small fibre nerves and monofilament mainly tests for large fibre nerves. Since small fibre nerves are involved in a person’s pain response, this may be useful to test for. Patients can then make changes to reduce the risk of foot issues (for example by wearing suitable footwear and checking feet regularly for any damage)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