An Observational Study to Assess Longitudinal Variation of Immune Biomarkers in Subjects at Risk for Development of Type 1 Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 4 - 40 |
| Updated: | 4/21/2016 |
| Start Date: | May 2013 |
| End Date: | September 2015 |
The Longitudinal Diabetes Biomarker Study: An Observational Study to Assess Longitudinal Variation of Immune Biomarkers in Subjects at Risk for Development of Type 1 Diabetes
This study is conducted in the United States of America (USA). The aim of the study is to
assess longitudinal variation of immune biomarkers in subjects at risk for development of
type 1 diabetes (T1D).
assess longitudinal variation of immune biomarkers in subjects at risk for development of
type 1 diabetes (T1D).
Inclusion Criteria:
- Subjects with general good health as judged by the investigator
- Participant tested positive at above or equal to 99th percentile for one or more of
three islet antibodies (GAD (glutamic acid decarboxylase), IA2 (islet antigen-2), IAA
(insulin autoantibody))
Exclusion Criteria:
- Any chronic disorder (diabetes at enrolment) or severe disease which, in the opinion
of the investigator, might jeopardize subject's safety or compliance with the
protocol
- Female of child-bearing potential who is pregnant, breast-feeding, or intends to
become pregnant
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