BLOOD SAMPLES FROM SUBJECTS WITH RECENT ONSET TYPE-1 DIABETES MELLITUS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Hypothesis: This multicenter, cross-sectional study will assess the ability of various T-cell assays to discriminate between subjects with Type-1 Diabetes versus those without, and to assess the reliability of each assay. Experimental Design: The study will enroll participants with Type-1 Diabetes of recent onset throughout the North American TrialNet sites, and the same number of participants in the European sites. A minimum of 20 to a maximum of 100 control subjects without diabetes will also be enrolled, separately in North America and in Europe. Each subject will be seen on two occasions at which a collection is obtained. The second collection will be obtained between 2 days and 28 days following the initial collection. All measurements performed in this protocol will be done in a blinded manner. The baseline visit (Visit 1) will assess whether or not a person is eligible to participate in the study. After completing the informed consent form and meeting eligibility requirements, the blood glucose measurement and the blood draw procedure may take place or be scheduled for another time. Eligibility will be reassessed at the second study visit (Visit 2) prior to collection of samples.