An evaluation of different devices to detect diabetic neuropathy in feet of diabetic patients
| ISRCTN | ISRCTN85524728 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85524728 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 325532 |
| Protocol serial number | CPMS 55937, IRAS 325532 |
| Sponsor | North Cumbria Integrated Care NHS Foundation Trust |
| Funder | Medipin Limited |
- Submission date
- 14/07/2023
- Registration date
- 24/08/2023
- Last edited
- 13/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
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.
Who can participate?
Adult patients aged 18 years or older with type 2 diabetes.
What does the study involve?
A single visit, at which the participant is assessed with the monofilament and Medipin devices.
What are the possible benefits and risks of participating?
The possible benefit for participants and patients in the future is that Medipin testing may identify DN that monofilament testing does not. There are no major personal safety risks anticipated regarding the tests. Both the Medipin device and monofilament press or touch the skin for around 1 second at a time, but do not pierce or damage the skin.
Where is the study run from?
North Cumbria Integrated Care NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
April 2023 to August 2024
Who is funding the study?
Medipin Limited (UK)
Who is the main contact?
Dr Leon Jonker, Leon.jonker@ncic.nhs.uk
Contact information
Scientific
R&D Department
North Cumbria Integrated Care NHS Foundation Trust
Penrith
CA11 8HX
United Kingdom
 ORCID ID |
0000-0001-5867-4663 |
|---|---|
| Phone | +44 1768 245975 |
| Leon.jonker@ncic.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional non-randomized study |
| Secondary study design | Non randomised study |
| Participant information sheet | 43955 MANDARIN PIS v1.1 20Apr2023.pdf |
| Scientific 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) |
| Study acronym | MANDARIN |
| Study objectives | The main objective of this study is to determine how many patients have diabetic neuropathy when tested, with the monofilament and Medipin device respectively, and to what degree there is an overlap between the two tests. |
| Ethics approval(s) |
Approved 25/04/2023, West Midlands - Coventry & Warwickshire Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, United Kingdom; +44 207 104 8379; coventryandwarwick.rec@hra.nhs.uk), ref: 23/WM/0095 |
| Health condition(s) or problem(s) studied | Diabetic neuropathy |
| Intervention | For this study, GP records will be screened to identify patients who have type II diabetes , and who meet the other inclusion criteria. Eligible patients will be invited to complete a postal survey. For those patients who respond positively with a completed reply slip expressing their interest, a researcher will then arrange a single study visit. During this visit, the study will be explained once more and patients can ask any questions they may have. Then written informed consent is obtained. Once done, the patient will have three different diabetic neuropathy screening tests (2x monofilament and 1x Medipin), plus they complete two questionnaires (one quality of life, one neuropathy screening). At the end, patients will be informed of the results and they will also receive an info leaflet on foot (self) care for diabetic patients. Their GP will also be notified of the results. There is no follow-up required for the study itself. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Medipin |
| Primary outcome measure(s) |
This study has only one study visit. At this visit, three primary outcome measures – all intended to screen for presence of diabetic neuropathy in the feet: |
| Key secondary outcome measure(s) |
Measured at a single time point: |
| Completion date | 31/08/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 139 |
| Total final enrolment | 389 |
| Key inclusion criteria | 1. Adult patients aged >=18 years 2. Patients with type II diabetes mellitus |
| Key exclusion criteria | 1. Aged <18 years 2. Any reasons for the patient being unable to follow the protocol, including lack of mental capacity to consent to taking part in the study (examples include dementia, severe learning disability). 3. The patient has concurrent (medical) conditions that in the opinion of the investigator may compromise patient safety or study objectives (examples include receiving palliative care, active cancer treatment, patient immobile) 4. Amputation of a lower limb 5. Confirmed and ongoing wound/ulcer located on the foot |
| Date of first enrolment | 01/05/2023 |
| Date of final enrolment | 20/08/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Carlisle
CA2 7HY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 19/10/2024 | 13/12/2024 | Yes | No | |
| HRA research summary | 20/09/2023 | No | No | ||
| Participant information sheet | version 1.1 | 20/04/2023 | 14/07/2023 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1.1 | 20/04/2023 | 14/07/2023 | No | No |
Additional files
- 43955 MANDARIN Protocol v1.1 20Apr2023.pdf
- Protocol file
- 43955 MANDARIN PIS v1.1 20Apr2023.pdf
- Participant information sheet
Editorial Notes
13/12/2024: The following changes were made to the study record:
1. Publication reference added.
2. The recruitment end date was changed from 31/12/2024 to 20/08/2024.
3. The overall study end date was changed from 31/12/2024 to 31/08/2024.
4. The intention to publish date was changed from 30/03/2025 to 19/10/2024.
5. Total final enrolment added.
09/01/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/01/2024 to 31/12/2024.
2. The overall study end date was changed from 30/03/2024 to 31/12/2024.
3. The intention to publish date was changed from 31/03/2024 to 30/03/2025.
20/09/2023: A link to the HRA research summary was added.
14/07/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
