Natural History Study of the Development of Type 1 Diabetes (IRB# 44868)

Status: Active



  • Principal Investigator: Ying Tai Chang, MD



Type 1 diabetes mellitus (T1D) is an immune-mediated disease in which insulin-producing  ß-cells are destroyed, resulting in life-long dependence on exogenous insulin. The incidence of T1D is increasing each year.  Despite clear evidence that genetic and immunologic factors play a key role in the development of T1D and the increasing characterization of the early metabolic abnormalities, the understanding of the natural history of T1D remains incomplete. The goals of the TrialNet Natural History Study of the Development of T1D are therefore to gain information about the pathogenesis and natural history of T1D.        



Inclusion Criteria:
1) 1-45 years of age and a sibling, offspring, or parent of an individual with T1D
2) 1-20 years of age and a niece, nephew, aunt, uncle, grandchild, cousin, or half sibling of an individual with T1D


Additional Study Details:

This study is divided into two parts: Screening and Monitoring.

Screening involves testing for the presence of biochemical autoantibodies associated with type 1 diabetes.



Participants who are positive for at least two autoantibodies on the same screening sample will enter semi-annual monitoring.

Participants with a single autoantibody will undergo a baseline monitoring visit consisting of the same measures described in the previous paragraph. 



Penn State Milton S. Hershey Medical Center



Pediatric Clinical Research Office




  • Endocrinology