ODIN study
Research type
Research Study
Full 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
IRAS ID
342532
Contact name
Stacey Fisher
Contact email
Sponsor organisation
North Cumbria Integrated Care NHS Foundation Trust
Clinicaltrials.gov Identifier
ODIN1, ODIN study
Duration of Study in the UK
4 years, 0 months, 31 days
Research summary
Diabetic neuropathy (DN) is a complication related to diabetes. This loss of protective sensation (LOPS) occurs because of nerve damage and can lead to further complications such as foot ulcers. The frequency of screening of patients for presence of DN is once yearly in clinical guidelines but the rationale and exact method for this is not clear; perhaps as a result of this, testing practices vary in clinical practice. DN diagnosis is complicated by the fact that different medical devices test for functioning of slightly different nerve types, either small or large fibre. Currently the NHS mainly uses a monofilament which checks predominantly large fibre function. However, there is evidence that small fibre nerves are damaged earlier in DN. A recent trial with a pinprick Medipin device – which targets mainly small fibres because it looks for a pain response – confirms this.
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). A minimum total of 214 patients with no neuropathy at baseline visit will be involved in the study. By using one group (cohort) of patients and following them up for three years, a clearer picture should emerge on the profile of DN and also if it is affected by other factors such as blood pressure and blood glucose control. The eventual results may inform how and when DN should be tested for, and may form foundation for future research into the potential treatment of DN.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
24/YH/0233
Date of REC Opinion
14 Oct 2024
REC opinion
Favourable Opinion