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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。假设：这项多中心横断面研究将评估各种t细胞检测区分1型糖尿病患者和非1型糖尿病患者的能力，并评估每种检测的可靠性。实验设计：该研究将在北美试验网站点招募近期发病的1型糖尿病患者，并在欧洲站点招募相同数量的参与者。北美和欧洲将分别招募至少20至最多100名无糖尿病的对照受试者。每个主题将在获得藏品的两次场合出现。第二次收集将在首次收集后的2天至28天内进行。在本方案中进行的所有测量将以盲法进行。基线访问（访问1）将评估一个人是否有资格参加研究。在完成知情同意书并符合资格要求后，血糖测量和抽血程序可以进行或安排在其他时间进行。在收集样本之前，将在第二次研究访问（访问2）时重新评估入选资格。

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.