ENABLE - Accessible testing of islet autoantibody may improve the clinical management of type 1 diabetes. We propose to validate the detection of islet autoantibodies for type 1 diabetes in self-collected capillary dried blood spot samples. Capillary blood spots do not require a visit to the doctor office and can be done without a phlebotomist, thereby lowering the testing barrier compared to venous blood draws. The assay performances will be compared to matching serum samples collected from the same individuals tested with FDA-cleared devices. The successful validation of the sample collection kit and assay may lead to the first regulatory-cleared assays for islet autoantibodies in self-collected sample types.
This study is currently enrolling.
Study Purpose: Clinical validation of islet autoantibody measurement in self-collected dried blood spot specimens. To be enrolled in this study, you must meet certain requirements. You may be eligible to participate if yo ...