Fr1da Insulin Intervention
Summary
Type 1 diabetes (T1D) results from an autoimmune destruction of the insulin-producing beta cells. The process of autoimmune destruction is identified by circulating islet autoantibodies to beta cell antigens, and is mediated by a lack of immunological self-tolerance. Self-tolerance is achieved by T cell exposure to antigen in the thymus or periphery in a manner that deletes autoreactive effector T cells or induces regulatory T cells. Immunological tolerance can be achieved by administration of antigen under appropriate conditions. Evidence is now emerging in humans that these approaches may be effective in chronic inflammatory diseases such as multiple sclerosis and allergy. Administration of oral insulin in multiple islet autoantibody-positive children offers the potential for inducing immunological tolerance to beta cells and thereby protect against further development progression to type 1 diabetes.
Timeline
- Start
- 2015-12-11
- Primary completion
- 2024-09-30
- Completion
- 2024-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin | Protein / enzyme biologic | 67.5 mg | Oral |