Abstract

TrialNet's mission is to bring disease modifying therapy to clinical use in type 1 diabetes (T1D) with a primary focus on conducting clinical trials at early stages of disease to prevent or delay clinical onset. TrialNet is an international consortium of twenty-five Clinical Centers and hundreds of Affiliate sites in US, Canada, UK, Sweden, Finland, Germany, Italy, and Australia. These sites together with the TrialNet Coordinating Center (TNCC), the TrialNet Clinical Hub (HUB), and members of our Collaborative Mechanistic Studies Panel (CMSP), (a) conduct natural history studies to describe the progression of T1D and identify individuals for clinical trials, (b) conduct clinical trials of disease modifying therapy both prior to and after clinical diagnosis, and (c) increase the scientific value of trials through mechanistic studies involving investigators within and external to TrialNet. The mission of the Type 1 Diabetes TrialNet Hub is to increase the efficiency of critical Network activities by supporting collaborative and innovative approaches for screening, recruitment, retention, trial development and implementation, and dissemination of results. With considerable success during the previous grant period, this application describes our proposal to continue to serve as the Diabetes TrialNet Clinical HUB. We focus on three areas; activities to (a) enhance risk screening to identify at-risk individuals, (b) enhance enrollment and retention in clinical trials, and (c) enhance clinical administration to effectively implement TrialNet's goals.

Public Health Relevance

Diabetes TrialNet is an international clinical trial network aimed to delay or prevent the onset of type 1 diabetes. This is an application from Dr. Greenbaum and the Benaroya Research Institute to continue to serve as the Diabetes TrialNet Clinical Hub whose activities are designed to facilitate achieving this goal by increasing efficiencies for identifying at-risk individuals, enrollment, and retention in trials; and disseminating results. The Director of the Diabetes TrialNet Clinical Hub will be part of the TrialNet leadership team including representatives of the NIH, the TrialNet Coordinating Center, and TrialNet chairman.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
2U01DK103282-06
Application #
9899045
Study Section
Special Emphasis Panel (ZDK1)
Program Officer
Leschek, Ellen W
Project Start
2014-07-31
Project End
2024-06-30
Budget Start
2019-09-16
Budget End
2020-06-30
Support Year
6
Fiscal Year
2019
Total Cost
Indirect Cost

  Institution

Name
Benaroya Research Institute at Virginia Mason
Department
Type
DUNS #
076647908
City
Seattle
State
WA
Country
United States
Zip Code
98101

  Publications

Vecchio, Federica; Lo Buono, Nicola; Stabilini, Angela et al. (2018) Abnormal neutrophil signature in the blood and pancreas of presymptomatic and symptomatic type 1 diabetes. JCI Insight 3:
Redondo, Maria J; Steck, Andrea K; Sosenko, Jay et al. (2018) Transcription Factor 7-Like 2 (TCF7L2) Gene Polymorphism and Progression From Single to Multiple Autoantibody Positivity in Individuals at Risk for Type 1 Diabetes. Diabetes Care 41:2480-2486
Sanda, Srinath; Type 1 Diabetes TrialNet Study Group (2018) Increasing ICA512 autoantibody titers predict development of abnormal oral glucose tolerance tests. Pediatr Diabetes 19:271-276
Yeo, Lorraine; Woodwyk, Alyssa; Sood, Sanjana et al. (2018) Autoreactive T effector memory differentiation mirrors ? cell function in type 1 diabetes. J Clin Invest 128:3460-3474
Redondo, Maria J; Geyer, Susan; Steck, Andrea K et al. (2018) A Type 1 Diabetes Genetic Risk Score Predicts Progression of Islet Autoimmunity and Development of Type 1 Diabetes in Individuals at Risk. Diabetes Care 41:1887-1894
Greenbaum, Carla J; Speake, Cate; Krischer, Jeffrey et al. (2018) Strength in Numbers: Opportunities for Enhancing the Development of Effective Treatments for Type 1 Diabetes-The TrialNet Experience. Diabetes 67:1216-1225
Haller, Michael J; Schatz, Desmond A; Skyler, Jay S et al. (2018) Low-Dose Anti-Thymocyte Globulin (ATG) Preserves ?-Cell Function and Improves HbA1c in New-Onset Type 1 Diabetes. Diabetes Care 41:1917-1925
Redondo, Maria J; Geyer, Susan; Steck, Andrea K et al. (2018) TCF7L2 Genetic Variants Contribute to Phenotypic Heterogeneity of Type 1 Diabetes. Diabetes Care 41:311-317
Sosenko, Jay M; Geyer, Susan; Skyler, Jay S et al. (2018) The influence of body mass index and age on C-peptide at the diagnosis of type 1 diabetes in children who participated in the diabetes prevention trial-type 1. Pediatr Diabetes 19:403-409
Writing Committee for the Type 1 Diabetes TrialNet Oral Insulin Study Group; Krischer, Jeffrey P; Schatz, Desmond A et al. (2017) Effect of Oral Insulin on Prevention of Diabetes in Relatives of Patients With Type 1 Diabetes: A Randomized Clinical Trial. JAMA 318:1891-1902

Showing the most recent 10 out of 16 publications