Understanding the Glycemic Profile of Pregnancy - Clinical Centers (U01 Clinical Trial Not Allowed) | RFA DK 18 018

Opportunity Information: Apply for RFA DK 18 018

The NIH, through NIDDK, offered this cooperative agreement (U01) funding opportunity to establish multiple U.S.-based Clinical Centers that can closely map how blood sugar levels normally change across the full span of pregnancy and how abnormal glucose regulation (dysglycemia) develops when it occurs. The central idea is to move beyond a single mid-pregnancy screening snapshot and instead capture a more complete, longitudinal picture of glycemia beginning early in pregnancy. Clinical Centers are expected to enroll pregnant participants in the first trimester and follow them at least through delivery, generating detailed, standardized data that can clarify typical glycemic trajectories as well as the timing, patterns, and progression of dysglycemia that may lead to gestational diabetes mellitus (GDM) or related complications.

A key feature of the program is that it is structured as a consortium under a cooperative agreement, meaning the awardees do not operate as isolated projects. Each funded Clinical Center would initially propose its own study design concept and, importantly, document concrete recruitment capacity (for example, access to prenatal populations, anticipated enrollment rates, retention strategies, and the clinical infrastructure needed for repeated measures through pregnancy). After awards are made, all Clinical Centers would work together with NIDDK to develop and carry out a uniform, consortium-wide protocol. In parallel, a separate companion FOA (RFA-DK-18-019) was intended to fund a Biostatistics Research Center that would support the overall study design, coordination, and analysis across sites.

The expected payoff of this work is practical and forward-looking. By understanding the full glycemic profile of pregnancy, the consortium aims to produce evidence that can improve how and when clinicians screen for GDM, potentially identifying risk earlier or distinguishing different dysglycemia patterns that matter for outcomes. The resulting data are also meant to guide the design and timing of future clinical trials (this FOA itself is "Clinical Trial Not Allowed") that test interventions to reduce adverse perinatal outcomes and to lower longer-term health consequences of pregnancy-related dysglycemia for both mothers and their children.

Administratively, the opportunity was issued as RFA-DK-18-018 in the discretionary category, using the cooperative agreement funding instrument (U01), within the Food and Nutrition/Health activity area (CFDA 93.847). The original closing date was March 26, 2019, and the listed award ceiling was $500,000. Eligibility was broad across U.S. entities, including state and local governments, tribal governments and tribal organizations, public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses, along with specific encouragement/eligibility for institutions serving Alaska Native and Native Hawaiian populations, AANAPISIs, Hispanic-serving institutions, HBCUs, TCCUs, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. Foreign institutions were explicitly not eligible to apply, and foreign components of U.S. organizations were not allowed under NIH policy definitions for this announcement.

• 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 - Clinical Centers (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 $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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