Rigor and Reproducibility for Biomarkers in Type 1 Diabetes Clinical Research

Key Facts

Status: Open

Posted date: February 4, 2026

Opportunity ID: 361235

Opportunity number: RFA-DK-27-140

Opportunity category: Discretionary

Agency name: National Institutes of Health

Agency code: HHS-NIH11

Award floor: $0

Award ceiling: $0

Cost sharing required: No

Funding Instrument Types
  • Grant
Category of Funding Activity
  • Health
Eligible Applicants
  • County governments
  • For-profit organizations other than small businesses
  • Independent school districts
  • Native American tribal governments (Federally recognized)
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education
  • Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education
  • Others
  • Private institutions of higher education
  • Public and State controlled institutions of higher education
  • Public housing authorities/Indian housing authorities
  • Small businesses
  • Special district governments
  • State governments
Tools
Categories (use these for quoted searches)
  • agency_code:hhs_nih11
  • category_of_funding_activity:health
  • cost_sharing_or_matching_requirement:false
  • eligible_applicants:county_governments
  • eligible_applicants:for_profit_organizations_other_than_small_businesses
  • eligible_applicants:independent_school_districts
  • eligible_applicants:native_american_tribal_governments_federally_recognized
  • eligible_applicants:native_american_tribal_organizations_other_than_federally_recognized_tribal_governments
  • eligible_applicants:nonprofits_having_a_501_c_3_status_with_the_irs_other_than_institutions_of_higher_education
  • eligible_applicants:nonprofits_that_do_not_have_a_501_c_3_status_with_the_irs_other_than_institutions_of_higher_education
  • eligible_applicants:others
  • eligible_applicants:private_institutions_of_higher_education
  • eligible_applicants:public_and_state_controlled_institutions_of_higher_education
  • eligible_applicants:public_housing_authoritiesindian_housing_authorities
  • eligible_applicants:small_businesses
  • eligible_applicants:special_district_governments
  • eligible_applicants:state_governments
  • funding_instrument_type:grant
  • opportunity_category:discretionary
  • status:open
Description

The main goal of this initiative is to establish a consortium with the overarching goal to advance the systematic identification, rigorous evaluation, validation, and assays harmonization of biomarkers that are critical to the prevention, diagnosis, and clinical management of Type 1 Diabetes (T1D). Despite significant advances in T1D research, there remains an urgent need for reliable and reproducible biomarkers that can capture the complexity of autoimmune processes, metabolic dysregulation, and individual patient variability. This initiative will leverage state-of-the-art methodologies in clinical chemistry, genomics, proteomics, metabolomics, immunophenotyping, and imaging, coupled with longitudinal patient cohorts and mining of Electronic Health Records (EHR). Within this consortium major efforts will be devoted to: 1) Harmonize established assays for biomarkers such as HbA1c and c-peptide, making sure that these assays are performed in a rigorous and reproducible manner in the clinical research community and in clinical practice. For this purpose, reference methods and materials will use a metrology approach and will be made available to the community; 2) Identify and validate other biomarkers that can be used for the prevention, diagnosis, and clinical management of T1D. It has been reported that the assays for several biomarkers routinely used in clinical research such as glucagon, amylin, chromogranin, insulin, pro-insulin and other pro-hormones are not reproducible across platforms or laboratories. For this purpose, this consortium will ensure that all assays for biomarkers routinely used in clinical research and for newly identified biomarkers are rigorously validated and assessed for reproducibility across several laboratories following a metrology approach.

Rigor and Reproducibility for Biomarkers in Type 1 Diabetes Clinical Research
The main goal of this initiative is to establish a consortium with the overarching goal to advance the systematic identification, rigorous evaluation, validation, and assays harmonization of biomarkers that are critical to the prevention, diagnosis, and clinical management of Type 1 Diabetes (T1D). Despite significant advances in T1D research, there remains an urgent need for reliable and reproducible biomarkers that can capture the complexity of autoimmune processes, metabolic dysregulation, and individual patient variability. This initiative will leverage state-of-the-art methodologies in clinical chemistry, genomics, proteomics, metabolomics, immunophenotyping, and imaging, coupled with longitudinal patient cohorts and mining of Electronic Health Records (EHR). Within this consortium major efforts will be devoted to: 1) Harmonize established assays for biomarkers such as HbA1c and c-peptide, making sure that these assays are performed in a rigorous and reproducible manner in the clinical research community and in clinical practice. For this purpose, reference methods and materials will use a metrology approach and will be made available to the community; 2) Identify and validate other biomarkers that can be used for the prevention, diagnosis, and clinical management of T1D. It has been reported that the assays for several biomarkers routinely used in clinical research such as glucagon, amylin, chromogranin, insulin, pro-insulin and other pro-hormones are not reproducible across platforms or laboratories. For this purpose, this consortium will ensure that all assays for biomarkers routinely used in clinical research and for newly identified biomarkers are rigorously validated and assessed for reproducibility across several laboratories following a metrology approach.
Rigor and Reproducibility for Biomarkers in Type 1 Diabetes Clinical Research
Open
National Institutes of Health
Health
Grant
State governments
County governments
Special district governments
Independent school districts
Public and State controlled institutions of higher education
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education
Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education
Private institutions of higher education
For-profit organizations other than small businesses
Small businesses
Others
2026-02-04