Understanding the Glycemic Profile of Pregnancy - Biostatistics Research Center (U01 Clinical Trial Not Allowed) | RFA DK 18 019

Opportunity Information: Apply for RFA DK 18 019

The funding opportunity titled "Understanding the Glycemic Profile of Pregnancy - Biostatistics Research Center (U01 Clinical Trial Not Allowed)" (RFA-DK-18-019) is a National Institutes of Health (NIH) cooperative agreement aimed at building the central biostatistics and data-science backbone for a broader multi-site pregnancy glycemia research consortium. The core scientific goal of the overall consortium is to map and understand how blood glucose patterns change across the entire course of pregnancy, starting as early as the first trimester and continuing through at least delivery, with particular attention to how dysglycemia emerges and progresses when it occurs. Rather than funding a clinical trial, this announcement specifically supports a Biostatistics Research Center that will partner closely with the clinical sites and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to design, standardize, and run the analytic and data-coordination elements needed to produce reliable, comparable results across all participating locations.

This Biostatistics Research Center is intended to work hand-in-hand with separately funded Clinical Centers (solicited under a companion announcement, RFA-DK-18-018) that will actually recruit and follow pregnant participants. Together, all awardees and NIDDK will operate as a cooperative research consortium, meaning the work will be collaborative and coordinated, with shared responsibility for developing and implementing a uniform protocol. In practical terms, the biostatistics center would be expected to help shape the study design, define outcomes and analytic plans, support data quality and harmonization across sites, and ensure that the consortium can accurately characterize glycemic trajectories over time. Because pregnancy physiology changes rapidly and glycemia can shift subtly before overt gestational diabetes mellitus (GDM) is recognized, the emphasis on careful, longitudinal characterization suggests the study will rely on rigorous methods for repeated measurements and time-varying analyses rather than one-time screening snapshots.

The public health and clinical motivation behind the project is to generate evidence that can improve real-world approaches to screening for GDM. By understanding when and how dysglycemia develops during pregnancy, the consortium aims to inform better screening strategies (including potentially earlier or more personalized screening) and to guide the timing and design of future interventional studies. The expectation is that stronger descriptive and mechanistic knowledge of glycemic profiles in pregnancy will help the field plan smarter clinical trials later, ultimately aiming to reduce adverse perinatal outcomes and lessen long-term health consequences associated with dysglycemia in pregnancy for both the mother and the child. Even though the award mechanism is not for a clinical trial, the results are framed as foundational: they should clarify the natural history of glycemia in pregnancy and identify critical windows when prevention or treatment could be most effective in subsequent trials.

Administratively, this opportunity falls under the NIH assistance listing CFDA 93.847 and uses the U01 cooperative agreement mechanism, which typically involves substantial NIH programmatic involvement compared with standard investigator-initiated grants. The application deadline listed in the source information was March 26, 2019, and the stated award ceiling was $1,500,000. The opportunity category is discretionary, and the activity category is listed under food and nutrition and health, reflecting the metabolic and maternal-child health focus. While the number of expected awards is not specified in the provided text, the structure implies a single or limited number of biostatistics coordinating awards designed to serve the entire consortium.

Eligibility is broad across U.S.-based organizations and includes many government entities (state, county, city or township governments, special district governments), education entities (independent school districts, public and state-controlled institutions of higher education, private institutions of higher education), tribal governments and organizations (federally recognized Native American tribal governments and other tribal organizations), nonprofits (both 501(c)(3) and non-501(c)(3) organizations), public housing authorities/Indian housing authorities, for-profit organizations (including small businesses), and other eligible applicants. The announcement also explicitly highlights additional eligible applicant types 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 (AANAPISISs), as well as faith-based or community-based organizations and certain regional organizations and U.S. territories or possessions. At the same time, the FOA clearly restricts foreign involvement: non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components as defined by NIH policy are not allowed. This means the work and participating institutional infrastructure are intended to be fully U.S.-based.

In summary, RFA-DK-18-019 funds the biostatistical leadership and centralized analytic capacity for a national consortium studying glycemia throughout pregnancy. The big deliverable is a high-quality, standardized characterization of glycemic patterns and the development of dysglycemia, with the practical intent of improving GDM screening strategies and laying the groundwork for better-timed and better-designed future clinical trials to protect maternal and offspring health.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Understanding the Glycemic Profile of Pregnancy - 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 2018-10-11.
• Applicants must submit their applications by 2019-03-26. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $1,500,000.00 in funding.
• 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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