Diabetic neuropathy in type II diabetes mellitus patients Nervous System Diseases
Conditions
Interventions
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 patient
Sponsors
North Cumbria Integrated Care NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients aged >=18 years 2. Patients with type II diabetes mellitus (diagnosed in accordance with NICE guidelines, Oct 2023)
Exclusion criteria
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])
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed