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

该项目的愿景是评估一种安全有效的1型糖尿病(T1D)筛查系统。Digostics正在与牛津大学和耶鲁大学合作，将其新的GTT@home产品纳入基于家庭的T1D筛查；GTT@home被视为向前迈出的一大步，用方便、易于使用的家庭测试取代了临床上的主要检测障碍--门诊口服葡萄糖耐量测试(OGTT)。C肽(胰岛素产生的指标)测试是T1D筛查的另一个重要元素；OGTT和C肽一起提供了重要的临床信息。牛津大学将很快评估两种用于实验室C肽检测的家庭样本采集方法，并将与GTT@home一起提供。样品将被邮寄到实验室进行检测。这种方法的潜在问题包括样本收集程序和邮寄样本进行实验室测试的需要，以及相关的复杂性和样本降解的风险。拟议的项目将评估修改用于临床测试的新的C肽横向流动测试设备(LFD)的使用。Digostics将用一款智能手机应用程序取代诊所台式LFD读取器，该应用程序可以使用智能手机摄像头对LFD测试进行成像，从而允许在家中收集测试数据，就像Digostics的GTT@home OGTT系统目前所做的那样。最终，可以使用改进的Digostics智能手机应用程序读取这两项测试。通过对LFD系统进行修改，使智能手机能够对LFD测试进行成像，并在云中对测试数据进行校准，将在斯旺西大学进行方法比较，将LFD护理点系统与LFD智能手机系统进行比较。如果智能手机C肽系统的性能在方法比较中是可接受的，它将被提交给牛津大学和耶鲁大学的T1D研究人员进行审查，以期确定后续计划的范围，以结合GTT@home评估家庭C肽LFD测试，两项测试都由Digostics移动应用程序读取，并将数据发送到Digostics Cloud进行处理。随着家用LFD测试和智能手机应用程序的相关使用现已被证明是可靠的，并被用户高度接受，在GTT@home的基础上实施C-肽应该是一项简单的任务。该项目的成功将是在T1D筛查方面向前迈出的重要一步，T1D筛查受到临床工作量和患者获得门诊检测的限制。

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.