RECENT ONSET TYPE-1 DIABETES MELLITUS STUDY OF USING FRESH BLOOD SAMPLES

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 假设： 这项多中心、横断面研究将评估各种T细胞测定区分1型糖尿病受试者与非1型糖尿病受试者的能力，并评估每种测定的可靠性。 实验设计： 本研究将在整个北美TrialNet研究中心招募近期发作的1型糖尿病受试者，并在欧洲研究中心招募相同数量的受试者。还将在北美和欧洲分别入组至少20例至最多100例无糖尿病的对照受试者。每个受试者将被观察两次。第二次采集将在首次采集后2至28天内进行。本方案中进行的所有测量均将以设盲方式进行。 基线访视（访视1）将评估受试者是否有资格参与研究。在完成知情同意书并满足合格性要求后，可进行血糖测量和抽血程序，或安排在另一时间进行。在第二次研究访视（访视2）时，将在采集样本前重新评估合格性。

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. The second collection will be obtained between 2 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.