Key Dates
- April 26, 2023 - Notice of Intent to Publish a Funding Opportunity Announcement for Evaluating Neurocognitive Complications of Pediatric Type 1 Diabetes (T1D) and Potential Risk and Protective Factors – Biostatistics Research Center (U01 Clinical Trial Not Allowed). See Notice NOT-DK-23-017.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The purpose of this Notice is to inform the community that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) intends to publish a Notice of Funding Opportunity (NOFO) that will solicit applications to establish a clinical consortium to better understand the neurocognitive impact of new onset type 1 diabetes (T1D) in pre-pubertal children. Clinical Centers (CCs) will establish a diverse cohort of pre-pubertal children newly diagnosed with T1D and will evaluate disease-related perturbations in neurocognitive function, as well as identify potential clinical, developmental, and/or environmental factors associated with neurocognitive function in pre-pubertal children with T1D. A separate NOFO (see NOT-DK-23-017) will establish a Biostatistics Research Center (BRC) to oversee the development and coordination of a core protocol to be adopted by each CC awarded under the NOFO referenced in the current Notice.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
The NOFO is expected to be published in late Spring 2023 with an expected application due date in Fall 2023.
This NOFO will utilize the U01 activity code. Details of the planned NOFO are provided below.
There is growing evidence of neurocognitive complications of T1D, with approximately 28% of middle-aged adults with T1D and 48% of older adults with T1D meeting criteria for clinically significant cognitive impairment. Early age of onset of T1D, longer disease duration, greater frequency and severity of hyperglycemia and hypoglycemia, hypoglycemia unawareness, DKA, and clinical severity at the time of diagnosis may increase risk for impairments in neurocognitive function. However, age-related changes and vascular complications associated with T1D in adults make isolating mechanisms associated with neurocognitive perturbations more complex.
Research in modern and diverse cohorts of pediatric patients with T1D earlier in the developmental spectrum and prior to the development of complex disease (e.g., moderate to severe complications of T1D, cardiovascular disease, dementia) can inform mechanisms, critical periods for prevention and intervention, and strategies to mitigate the risk of neurocognitive complications of T1D in later life.
Furthermore, recent advances in neuroimaging, computerized cognitive assessment, and automated diabetes management systems provide researchers with a unique opportunity to improve the characterization of both neurocognitive and clinical aspects of pediatric T1D and identify critical risk or protective factors for common neurocognitive complications.
To address these needs, the planned NOFO will invite applications designed to identify and characterize neurocognitive complications of new-onset T1D. This Notice encourages investigators with expertise and insights into these areas to begin to consider applying for this new NOFO.
Collaborative teams combining expertise in type 1 diabetes, the developing brain, human neuroimaging, and automated diabetes management systems will be encouraged, and these investigators should consider establishing a collaborative team that could apply under the NOFO.
Up to 10 awardees from this NOFO and 1 awardee from the associated BRC NOFO (see NOT-DK-23-017) will form a clinical consortium that will collaborate in designing and implementing a uniform study protocol.
Findings from this observational study are expected to advance our understanding of the impact of T1D on the developing brain and identify risk and protective factors associated with neurocognitive functioning to ultimately inform on effective strategies to decrease adverse neurodevelopmental outcomes and long-term neurocognitive sequelae of T1D.
Funding Information
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 (see NOT-DK-23-017) and up to ten Clinical Centers (under the NOFO referenced in the current Notice).
10
Application budgets for the Clinical Centers need to reflect the actual needs of the proposed project and may not exceed $200,000 in direct costs for grant year 1 (planning year) and $400,000 in direct costs for each grant year 2 - 5.
93.847
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government
Applications are not being solicited at this time.
Inquiries
Please direct all inquiries to:
Maureen Monaghan Center, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-402-3269
Email: maureen.center@nih.gov
Theresa Teslovich Woo, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-480-1871
Email: theresa.woo@nih.gov
and Human Services (HHS)
