Feasibility of a smartphone based c-peptide lateral flow test for use in home based screening for type 1 diabetes

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The vision of this project is to evaluate a safe and efficient screening system for type 1 diabetes (T1D). Digostics is working with Oxford and Yale universities to incorporate its novel GTT@home product into home-based T1D screening; GTT@home is seen as a major step forward, replacing in-clinic oral glucose tolerance test (OGTT), a major barrier to testing, with a convenient, easy to use home test.Testing for c-peptide (an indicator of insulin production), is another important element of T1D screening; OGTT and c-peptide together provide important clinical information. Oxford University will soon evaluate 2 methods of home sample collection for laboratory c-peptide testing, to be provided with GTT@home. The samples will be mailed to a lab for testing. Potential issues with this approach include the sample collection procedure and the need to mail the samples for laboratory testing, with the associated complexities and risk of sample degradation.The proposed project will evaluate modifying the use of a new lateral flow test device (LFD) for c-peptide that is intended for in-clinic testing. Digostics will replace the in-clinic benchtop LFD reading unit with a smartphone app that can image the LFD test using a smartphone camera, allowing the test data to be collected from home, as happens currently with Digostics' GTT@home OGTT system. Ultimately, the two tests could be read using a modified Digostics smartphone app.With the LFD system modified to enable imaging of the LFD test by smartphone, and with calibration of the test data performed in the Cloud, a method comparison will be undertaken at Swansea University, comparing the LFD point of care system to the LFD smartphone system. If the performance of the smartphone c-peptide system is acceptable in the method comparison, it will be presented to the T1D researchers at Oxford and Yale Universities for review, with a view to scoping a subsequent programme to evaluate home c-peptide LFD testing in combination with GTT@home, with both tests being read by a Digostics mobile app and data sent to the Digostics Cloud for processing. With home LFD testing and the associated use of smartphone apps now proven to be reliable and highly acceptable to users, implementing c-peptide alongside GTT@home should be a straightforward task. Success in this project would present a major step forward in T1D screening, which is constrained by clinic workload and patient accessibility to in-clinic testing.