Assessing Remote Confirmation of Type 1 Diabetes (ARC-T1D)
Research type
Research Study
Full title
Evaluating the practicalities & potential benefits of remote C-peptide testing in clinical practice to confirm established Type 1 diabetes.
IRAS ID
338864
Contact name
Nicholas Thomas
Contact email
Sponsor organisation
Royal Devon University Healthcare NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
It is not always easy to diagnose Type 1 diabetes (T1D) in adults because the symptoms can overlap with Type 2 diabetes (T2D) and misclassification of diabetes type can occur. This matters as T2D cases misclassified as having T1D could potentially receive a lifetime of unnecessary insulin treatment.
Whether someone needs treating as T1D can be confirmed by measuring their insulin levels, using a blood test called C-peptide. That test should be done at least 3 years after diabetes diagnosis as closer to diagnosis, insulin levels in T1D and T2D can overlap.
A study in Scotland measured C-peptide in a clinic of patients treated as T1D showing around 1 in 15 of cases were misclassified. As a result, all patients in Scotland with a long –standing diagnosis of T1D now have C-peptide measured and that is likely to be recommended across the UK. In addition to the extra burden on clinical staff to collect those blood samples, not all UK laboratories are set up for C-peptide tests so testing all patients will be very challenging.
The team in Exeter have validated a method for measuring insulin levels (C-peptide test) in finger-prick samples which can be collected by patients at home and posted to a hospital laboratory. Clinic visits are not needed and testing can be done at a hospital laboratory where C-peptide testing is already routinely available.
This study will assess whether this approach is workable and useful by requesting & testing finger-prick blood samples from a general population of adult T1D patients at a hospital diabetes clinic. To properly assess this method, we will look at the number of samples returned, the number of patients choosing not to take part, the staff time required as well as the number of patients with a C-peptide result that indicates the type of diabetes is not T1D.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
24/NW/0277
Date of REC Opinion
24 Oct 2024
REC opinion
Further Information Favourable Opinion