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

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。假设：这项多中心的横断面研究将评估各种T细胞检测方法区分1型糖尿病患者和非1型糖尿病患者的能力，并评估每种检测方法的可靠性。实验设计：该研究将在北美TrialNet网站招募新近发病的1型糖尿病患者，并在欧洲网站招募相同数量的参与者。北美和欧洲也将分别招募至少20到最多100名没有糖尿病的对照受试者。每个主题都将出现在两个获得收藏的场合。第二次收集将在首次收集后2天至28天内获得。在此协议中执行的所有测量都将以盲目的方式进行。基线访问(访问1)将评估一个人是否有资格参与研究。在填写知情同意书并满足资格要求后，可以进行血糖测量和抽血程序，或安排在另一时间进行。在收集样本之前，将在第二次考察访问(访问2)时重新评估资格。

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.