Evaluating Neurocognitive Complications of Pediatric Type 1 Diabetes (T1D) and Potential Risk and Protective Factors Biostatistics Research Center (U01 Clinical Trial Not Allowed)

Background
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is inviting applications for a Biostatistics Research Center (BRC) to participate in a clinical consortium to better understand the neurocognitive impact of new onset type 1 diabetes (T1D) in pre-pubertal children. The goal is to advance understanding of the impact of T1D on the developing brain and identify risk and protective factors associated with neurocognitive functioning to inform effective strategies to decrease adverse neurodevelopmental outcomes and long-term neurocognitive sequelae of T1D.

Grant Details
The BRC will collaborate with Clinical Centers (CCs) to develop and implement an observational study to better understand the neurocognitive impact of T1D in pre-pubertal children. The study aims to establish a diverse longitudinal cohort of pediatric patients newly diagnosed with T1D, evaluate potential risk and protective factors associated with T1D-related neurocognitive impact, and assess potential associations between use of newer diabetes management technologies and neurocognitive functioning among children with T1D.

The BRC will provide biostatistical and analytic expertise, coordinate study design and protocol development, oversee protocol implementation across the CCs, lead data analyses, ensure participant confidentiality and safety, conduct training and certification of study staff, oversee implementation of the study protocol, coordinate communication among CCs, manage activities related to the single Institutional Review Board (IRB), establish procedures for negotiation of third-party agreements, develop processes to administer and manage entities throughout the project, prepare detailed reports for the Steering Committee, NIDDK staff, and Observational Safety Monitoring Board (OSMB), identify fixed and variable costs, establish scientific collaborations for specialized outcomes, oversee creation and management of key study cores, coordinate interactions among individual CCs, standardize protocols, training of staff, reliability testing for any assessment proposed to ensure consistent administration across research sites.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits with 501(c)(3) IRS status or without 501(c)(3) IRS status, for-profit organizations including small businesses, local governments, state governments, county governments, city or township governments, special district governments, Indian/Native American Tribal Governments (Federally Recognized), Indian/Native American Tribal Governments (Other than Federally Recognized), federal agencies or eligible agencies of the Federal Government. Foreign institutions are not eligible to apply.

Period of Performance
The project period is up to 5 years. The first year will be devoted to planning with a budget not exceeding $1.2 million in direct costs. Subsequent years will have a budget not exceeding $2.2 million in direct costs per year.

Grant Value
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) intends to commit $5.3 million in FY 2024 to support this consortium in grant year 1. It is anticipated that awards will be made to one Biostatistics Research Center under this NOFO.