Assessment of bloodspot tests for insulin, c-peptide and glucose
Research type
Research Study
Full title
Development and Validation of Dried Bloodspot Assays for Insulin, C-peptide and Glucose, and a review of their clinical application in the investigation of disordered glucose metabolism, including their impact on the patient experience.
IRAS ID
337899
Contact name
Gwen Wark
Contact email
Sponsor organisation
Royal Surrey County Hospital
Duration of Study in the UK
2 years, 3 months, 27 days
Research summary
The aim of this project is to develop tests for insulin, c-peptide and glucose in dried bloodspot samples. These tests are already used in blood samples to help the diagnosis of type 1 and 2 diabetes, as well as in the investigation of low blood sugar. However, these blood samples are unstable so they need to reach the laboratory promptly after collection, limiting their use in the community. Furthermore, collecting blood samples while the patient is symptomatic is crucial for accurate interpretation when these tests are used to investigate low blood sugar. However, this can be very challenging as symptoms are often unpredictable. There is therefore a need for an easier alternative that can be collected anywhere and at any time, without the need for phlebotomy. Bloodspot samples should help with this issue as samples can be collected at home from a simple finger prick.
This project will develop these tests and compare the results to the current method in blood samples, to ensure that bloodspots give reliable results. To do this we will collect bloodspot samples from adult patients who are also having blood samples taken for these tests and compare the results. We will also use patient questionnaires to assess patient opinion on the new service.
Once the assays have been validated, we will assess the impact of the bloodspot service by completing a service evaluation. We aim to complete this second phase of the project at least 12 months after the new service has been introduced into routine practice. This will allow us to see whether the new service has improved time to diagnosis, and patient questionnaires will be used to assess the patient experience.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
24/WM/0112
Date of REC Opinion
17 Jun 2024
REC opinion
Further Information Favourable Opinion