Elucidating the heterogeneity of impaired awareness of hypoglycemia in Type 1 Diabetes (T1D) - Biostatistics Research Center (U01 Clinical Trial Not Allowed) | RFA DK 21 036

Opportunity Information: Apply for RFA DK 21 036

This funding opportunity, RFA-DK-21-036, is a National Institutes of Health (NIH) cooperative agreement (U01) focused on supporting a dedicated Biostatistics Research Center (BRC) within a larger, coordinated clinical consortium. The scientific problem it targets is impaired awareness of hypoglycemia (IAH) in adults with Type 1 Diabetes (T1D), a dangerous condition where people lose the ability to recognize early warning symptoms of low blood glucose. Because IAH substantially increases the risk of severe hypoglycemia, accidents, and emergency medical events, the program is built around a practical and clinically important question: why do some individuals regain hypoglycemia awareness and improved counter-regulatory (hormonal and physiological) defenses when hypoglycemia is reduced, while others do not? The central theme is heterogeneity, meaning the consortium is explicitly designed to understand the differences across participants in the likelihood, speed, and durability of recovery in awareness and counter-regulatory responses.

The BRC is intended to serve as the consortiums statistical and data science backbone rather than acting as a stand-alone clinical site. In a typical NIH cooperative agreement model, the BRC would be expected to work closely with NIH staff and the funded Clinical Centers to ensure harmonized study design, rigorous statistical planning, high-quality data capture, and reliable inference across multiple sites. The BRC role generally includes responsibilities such as developing and overseeing statistical analysis plans, building and managing integrated databases, coordinating data standards across centers, supporting interim monitoring and reporting, addressing missing data and protocol deviations, and leading or co-leading cross-site analyses that connect continuous glucose monitoring (CGM) metrics, technology use patterns, and physiologic testing outcomes to changes in IAH. The FOA is also positioned to support deeper analytic work aimed at uncovering predictors, subgroups, and mechanistic correlates that explain why restoration of awareness and counter-regulation varies from person to person.

This announcement is paired with a separate companion FOA for Clinical Centers (RFA-DK-21-020). The Clinical Centers are tasked with the hands-on clinical research, including deploying state-of-the-art diabetes technologies intended to optimize HbA1c while minimizing hypoglycemia, then evaluating whether that approach can restore hypoglycemia awareness and improve counter-regulatory responses in people with T1D and IAH. Those sites are also charged with identifying which CGM-derived exposure metrics (for example, time in range (TIR), time below range, and other CGM summaries) and what magnitude and duration of improved glycemic patterns are most associated with restoration of awareness. A third clinical goal is to validate commonly used self-report questionnaires and assessments of IAH by comparing them against physiologic measurements from advanced metabolic testing, helping determine how well subjective reporting aligns with objective biological responses. The BRC, by design, underpins these objectives by ensuring the statistical framework can connect technology exposure, CGM time-series features, questionnaire-based measures, and physiologic endpoints in a coherent, reproducible way.

Administratively, the award mechanism is a U01 cooperative agreement, and the FOA is explicitly labeled Clinical Trial Not Allowed, meaning the BRC application itself should not propose an independent clinical trial. Instead, it supports the consortium research through coordination, analysis, and related infrastructure in partnership with the clinical awardees. The opportunity is categorized under health-related federal assistance (CFDA 93.847) and falls within the broader activity area of food and nutrition/health, consistent with NIH institute missions in diabetes and metabolic disease research.

Eligibility is broad and includes many common U.S. applicant types: state, county, and city governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations; public housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education where relevant); for-profit organizations (other than small businesses); small businesses; and other organizations. The FOA also highlights inclusion of institutions that serve specific communities, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and eligible federal agencies. In terms of geography, non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply as the applicant organization, and non-U.S. components of U.S. organizations are not eligible. However, foreign components are allowed as defined by the NIH Grants Policy Statement, which typically means a U.S.-based applicant may include a justified, well-defined foreign collaboration component when permitted under NIH policy.

Key identifying details from the source record include the funding opportunity title and number (RFA-DK-21-036), the sponsoring agency (NIH), the instrument type (cooperative agreement), and the original closing date listed as 2022-03-31, with a creation date of 2022-01-04. An award ceiling is not specified in the provided excerpt, and expected awards are not listed in the captured fields, so prospective applicants would normally confirm budget limits, project period expectations, and consortium structure requirements in the full FOA text. Overall, the opportunity is best understood as a specialized, consortium-enabling grant aimed at delivering the statistical leadership and data infrastructure needed to explain patient-to-patient differences in recovery from impaired hypoglycemia awareness when modern diabetes technologies and carefully measured physiologic outcomes are brought together in a coordinated, multi-center research program.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Elucidating the heterogeneity of impaired awareness of hypoglycemia in Type 1 Diabetes (T1D) - Biostatistics Research Center (U01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2022-01-04.
• Applicants must submit their applications by 2022-03-31. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township 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.

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