ODIN study, a long-term study to assess the presence and progress of diabetic neuropathy (impaired or lack of sensation in feet) using the Medipin pin-prick and monofilament devices
| ISRCTN | ISRCTN12860460 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12860460 |
| IRAS number | 342532 |
| Secondary identifying numbers | CPMS 65006 |
- Submission date
- 06/11/2024
- Registration date
- 07/11/2024
- Last edited
- 07/11/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Diabetic neuropathy (DN) is a complication of diabetes that causes nerve damage, leading to a loss of protective sensation (LOPS) and potentially resulting in foot ulcers. Current guidelines recommend yearly screening for DN, but the methods and reasons for this are not well-defined, leading to varied testing practices. Different devices test different types of nerves, with the NHS mainly using a monofilament for large nerve fibres. However, small nerve fibres may be damaged earlier. This study, called the ODIN trial, aims to use both the Medipin (for small fibres) and monofilament (for large fibres) to track DN development and progression in diabetes patients.
Who can participate?
The study will include at least 214 patients who do not have neuropathy at the start of the study.
What does the study involve?
Participants will be tested with both the Medipin and monofilament devices to check their nerve function. They will be followed up over three years to see if their nerve sensation changes, from normal to reduced or absent sensation.
What are the possible benefits and risks of participating?
The study checks for diabetic neuropathy over a period of three years and also compares the Medipin test to normal NHS practice (testing with monofilament). This will therefore give patients an overview of how the sensation in their feet may change over time. It is possible the Medipin test may detect diabetic neuropathy where monofilament testing has not. Some participants may also be tested for the first time with the monofilament device, if they have not had this done before by their regular care team. By taking part, patients may possibly get support and treatment for diabetic neuropathy when otherwise they would not have. However, patients’ GP and/or diabetes care team will continue to manage their diabetes, whether they take part in this study or not. Patients cannot claim payments, reimbursement of expenses or any other benefits or incentives for taking part in this research (we will try and see patients close to their home to minimise any inconvenience).
There are no major personal safety risks anticipated regarding taking part in this study. The Medipin device and monofilament press or touch the skin of the big toe for around 1 second at a time. This may cause slight discomfort, but is actually essential to the test. The tests are checking if nerves sense the pressure of the monofilament, or the pinprick of the Medipin. There should be no lasting discomfort, pain, or skin damage. The monofilament will be sanitised in-between patients, as per standard practice. The Medipin is single-use and will be thrown away after being used on one patient.
If patients decide to take part in the study, and the NHS Trust, GP, or the research team learns of important new information that might affect their willingness to remain in the study, they will tell participants as soon as possible. Appropriate precautions are in place to ensure medical and personal information is kept safe.
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?
May 2024 to August 2028
Who is funding the study?
Medipin Limited (UK)
Who is the main contact?
Leon Jonker, Leon.Jonker@ncic.nhs.uk
Contact information
Scientific
North Cumbria Integrated Care NHS FT, Penrith Hospital, New Bridge Lane
Penrith
CA11 8HX
United Kingdom
 ORCID ID |
0000-0001-5867-4663 |
|---|---|
| Phone | +44 1228 602173 |
| Leon.jonker@ncic.nhs.uk |
Study information
| Study design | Interventional non-randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | 46346 ODIN PIS v1.0 dd15Oct2024 - A4 format.pdf |
| Scientific title | ODIN (Observation of DIabetic Neuropathy) study: A prospective cohort study screening for presence and progress of diabetic neuropathy in type II diabetes mellitus patients, using MEDIPIN pinprick and monofilament devices |
| Study acronym | ODIN |
| Study hypothesis | In this ODIN trial the aim is to utilise both the Medipin and monofilament devices to describe the development and potential progression of DN in diabetes patients. The main objective is to see how many patients’ status may go from ‘no neuropathy’ (sharp sensation with Medipin) to ‘reduced sensation’ (dull sensation), and from ‘reduced sensation to no sensation’ (complete absence of sensation). |
| Ethics approval(s) |
Approved 17/10/2024, Yorkshire and the Humber – South Yorkshire Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 2071048184; southyorks.rec@hra.nhs.uk), ref: 24/YH/0233 |
| Condition | Diabetic neuropathy in type II diabetes mellitus patients |
| Intervention | 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 (1x 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. For this study patients are follow up for three years (36 months). They will have a follow-up appointment at month 18 and month 36. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Medipin |
| Primary outcome measure | 1. Patients’ sensation to Medipin pin-prick application (both ternary and visual analogue scale) will be measured at baseline (0 months), and at 18months and 36months follow-up 2. Patients’ sensation to 10g monofilament application (ternary scale) will be measured at baseline (0 months), and at 18months and 36months follow-up |
| Secondary outcome measures | 1. Patients’ quality of life will be measured using validated EQ-5D-5L scale, done at at baseline (0 months), and at 18months and 36months follow-up 2. Patients’ neuropathy related symptoms will be measured using validated Michigan Neuropathy Screening Instrument symptom questionnaire , done at at baseline (0 months), and at 18months and 36months follow-up 3. Patients’ blood glucose control will be measured using HbA1c test (if results obtained as part of standard care) , done at at baseline (0 months), and at 18months and 36months follow-up 4. Patients’ blood pressure will be measured using standard blood pressure measurement device (if results obtained as part of standard care) , done at at baseline (0 months), and at 18months and 36months follow-up |
| Overall study start date | 01/05/2024 |
| Overall study end date | 31/08/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 250; UK Sample Size: 250 |
| Participant inclusion criteria | 1. Adult patients aged >=18 years 2. Patients with type II diabetes mellitus (diagnosed in accordance with NICE guidelines, Oct 2023) |
| Participant exclusion criteria | 1. Aged < 18 years 2. Confirmed complete diabetic neuropathy (patients can be consented if this is not known beforehand, but will then not be included in diabetic neuropathy progression analysis) 3. 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). 3.1. 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, medical condition that contraindicates giving routine blood samples) 4. Amputation of hallux, foot, or complete lower limb (at baseline) 5. Confirmed and ongoing wound / ulcer located on the foot (at baseline). This may impede ability to conduct the DN tests (i.e., wound and dressing/bandage covering the hallux [big toe]) |
| Recruitment start date | 01/12/2024 |
| Recruitment end date | 31/08/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cumberland Infirmary
Infirmary Street
Carlisle
CA2 7HY
United Kingdom
Sponsor information
Hospital/treatment centre
Pillars Building, Cumberland Infirmary, Infirmary Street
CarlIsle
CA2 7HY
England
United Kingdom
| Phone | +44 1228608926 |
|---|---|
| research@ncic.nhs.uk | |
| Website | https://www.ncic.nhs.uk/ |
"ROR" |
https://ror.org/003hq9m95 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/11/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| 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? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.0 | 15/10/2024 | 06/11/2024 | No | Yes |
| Protocol file | version 1.0 | 15/10/2024 | 06/11/2024 | No | No |
Additional files
Editorial Notes
06/11/2024: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
