Type 1 Diabetes TrialNet

Project: Research project

Description

DESCRIPTION (provided by applicant):
Type 1 diabetes mellitus arises in genetically predisposed individuals as a
consequence of immune mediated destruction of the pancreatic islet insulin
secreting beta cells. The onset of clinical symptoms of diabetes represents the
end point of a chronic progressive decline in beta-cell function and occurs
when the majority of beta-cells have been lost. The Diabetes Prevention Trial
for Type 1 Diabetes (DPT-1) has been conducting studies to determine whether
early intervention using antigen-based therapies (parenteral or oral insulin)
in nondiabetic relatives of persons with Type 1 diabetes can delay the
development of Type 1 diabetes as a clinical disease and to conduct long term
follow-up of subjects developing diabetes. It is recognized that it is likely
to be necessary to assess multiple intervention strategies in different cohorts
of individuals before the disease process leading to Type 1 diabetes can be
completely interrupted. To that end, Type 1 Diabetes TrialNet creates an
expanded national diabetes trial network of cooperative clinical research
groups and support facilities. It is envisioned that TrialNet will conduct
pilot and expanded studies to evaluate new approaches to prevent or ameliorate
Type 1 diabetes, natural history and genetics studies in populations screened
for or enrolled in these studies, and other studies that may result in an
improved understanding of Type 1 diabetes and the prevention of the disease.
This application seeks to provide the core support facilities and
infrastructure to complete the DPT-1 protocols and achieve their objectives and
to provide Type 1 Diabetes TrialNet appropriate experienced core support
facilities. The applicant has been the Operations Coordinating Center (OCC)
and, through a subcontract, the Data Monitoring Unit (DMU) for DPT-I since its
inception, providing administrative, statistical and operations support; and
coordinating other core facilities, including core laboratories (to assure
standardized, reliable methods), compounding and dispensing pharmacies, and
public relations support. That network developed for DPT-1 provides the
platform on which to build the enhanced infrastructure for Type 1 Diabetes
TrialNet. Thus, these core facilities provide the basic structure for an
ongoing series of clinical trials in TrialNet. This application describes an
experienced team that is expert in the design and conduct of
multi-institutional diabetes prevention trials, established policies and
procedures, and an outstanding working relationship with clinical centers to
meet the needs of TriaINet.
StatusFinished
Effective start/end date9/29/017/31/09

Funding

  • National Institutes of Health: $1,596,143.00
  • National Institutes of Health: $1,079,364.00
  • National Institutes of Health: $1,761,472.00
  • National Institutes of Health: $835,944.00
  • National Institutes of Health: $847,912.00

Fingerprint

Type 1 Diabetes Mellitus
Pharmacies
Natural History
Islets of Langerhans
Clinical Trials
Insulin
Antigens

ASJC

  • Medicine(all)