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.Apply for RFA DK 18 018
- 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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Frequently Asked Questions (FAQs)
What is this NIH/NIDDK funding opportunity trying to accomplish?
This cooperative agreement (U01) is intended to establish multiple U.S.-based Clinical Centers to closely map how blood sugar (glycemia) normally changes across the full span of pregnancy and how abnormal glucose regulation (dysglycemia) develops when it occurs. The emphasis is on building a detailed, longitudinal picture beginning early in pregnancy rather than relying on a single mid-pregnancy screening snapshot.
What is the main scientific focus of the proposed research?
The program focuses on characterizing typical glycemic trajectories throughout pregnancy and identifying the timing, patterns, and progression of dysglycemia that may lead to gestational diabetes mellitus (GDM) or related complications.
Why does the opportunity emphasize longitudinal data instead of one-time screening?
The central concept is to move beyond a single mid-pregnancy screening moment and instead capture repeated measures across pregnancy starting in the first trimester. This is meant to clarify how glycemia evolves over time and when dysglycemia begins and progresses.
What types of awardees are expected to be funded?
The announcement anticipates funding multiple U.S.-based Clinical Centers under a consortium structure, rather than independent stand-alone projects.
When are Clinical Centers expected to enroll participants?
Clinical Centers are expected to enroll pregnant participants in the first trimester.
How long must participants be followed?
Participants are expected to be followed at least through delivery.
What kinds of data are Clinical Centers expected to generate?
Clinical Centers are expected to generate detailed, standardized data from repeated measures across pregnancy. The intent is to produce data that clarify normal glycemic profiles as well as the development and progression of dysglycemia.
How is this program structured (individual projects vs. consortium)?
This is structured as a consortium under a cooperative agreement. Awardees are not expected to operate as isolated projects; instead, funded Clinical Centers will work together with NIDDK after awards are made.
What does it mean that this is a cooperative agreement (U01)?
Under a cooperative agreement, the project is carried out in collaboration with the funding Institute. Here, Clinical Centers are expected to work with NIDDK and with each other to develop and carry out a uniform, consortium-wide protocol after awards are made.
Do Clinical Centers propose their own study design?
Yes. Each funded Clinical Center would initially propose its own study design concept. After awards, all Clinical Centers would collaborate with NIDDK to develop and implement a uniform protocol across the consortium.
What must applicants document about recruitment and enrollment?
Applicants are expected to document concrete recruitment capacity, such as access to prenatal populations, anticipated enrollment rates, retention strategies, and the clinical infrastructure needed for repeated measures through pregnancy.
Is there a separate coordinating or analytics component mentioned?
Yes. A separate companion FOA (RFA-DK-18-019) was intended to fund a Biostatistics Research Center to support overall study design, coordination, and analysis across sites.
What practical outcomes is the consortium aiming to deliver?
The goal is to generate evidence that can improve how and when clinicians screen for GDM, including potentially identifying risk earlier and distinguishing dysglycemia patterns that may matter for outcomes. The data are also meant to guide the design and timing of future clinical trials to reduce adverse perinatal outcomes and longer-term health consequences for mothers and children.
Are clinical trials allowed under this funding opportunity?
No. The FOA is explicitly described as "Clinical Trial Not Allowed."
What is the FOA number and what agency component issued it?
The opportunity was issued as RFA-DK-18-018 by the NIH through NIDDK.
What is the funding mechanism/instrument for this opportunity?
The funding instrument is a cooperative agreement (U01).
What is the activity area and CFDA number listed?
The activity area is Food and Nutrition/Health, and the CFDA number listed is 93.847.
What was the application closing date?
The original closing date listed was March 26, 2019.
What was the listed award ceiling?
The listed award ceiling was $500,000.
Who was eligible to apply?
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), small businesses, and U.S. territories or possessions.
Were any specific institution types encouraged or explicitly included?
Yes. The announcement included 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.
Are foreign institutions eligible to apply?
No. Foreign institutions were explicitly not eligible to apply.
Are foreign components of U.S. organizations allowed?
No. Foreign components of U.S. organizations were not allowed under NIH policy definitions for this announcement.
Does this program focus only on gestational diabetes (GDM)?
The program focuses broadly on glycemic trajectories in pregnancy and the development of dysglycemia, including dysglycemia that may lead to GDM or related complications.
What stage of pregnancy is emphasized for starting data collection?
Data collection is intended to begin early in pregnancy, with enrollment expected in the first trimester.
How will consistency across multiple Clinical Centers be achieved?
After awards are made, the Clinical Centers are expected to work together with NIDDK to develop and carry out a uniform, consortium-wide protocol, enabling standardized data generation across sites.
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|---|
| Human Pancreas Analysis Program for Type-2 Diabetes (HPAP-T2D) (U01 Clinical Trial Not Allowed) Apply for RFA DK 18 016 Funding Number: RFA DK 18 016 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $2,000,000 |
| Human Pancreas Analysis Program (HPAP) (U01 Clinical Trial Not Allowed) Apply for RFA DK 18 015 Funding Number: RFA DK 18 015 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $30,000,000 |
| Understanding the Glycemic Profile of Pregnancy - Biostatistics Research Center (U01 Clinical Trial Not Allowed) Apply for RFA DK 18 019 Funding Number: RFA DK 18 019 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $1,500,000 |
| Diabetes Research Centers (P30) Apply for RFA DK 18 020 Funding Number: RFA DK 18 020 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| NIDDK Education Program Grants (R25 Clinical Trial Not Allowed) Apply for PAR 19 030 Funding Number: PAR 19 030 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $100,000 |
| Human Islet Research Network - Consortium on Targeting and Regeneration (HIRN-CTAR) (U01 Clinical Trial Not Allowed) Apply for RFA DK 18 014 Funding Number: RFA DK 18 014 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $550,000 |
| Medical Simulators for Practicing Patient Care Providers Skill Acquisition, Outcomes Assessment and Technology Development (R01 Clinical Trial Not Allowed) Apply for PA 19 065 Funding Number: PA 19 065 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Support for Small Business Innovation Research to Develop New Open and Closed-Loop Automated Technologies for Better Type 1 Diabetes Therapy and Monitoring (SBIR) (R43/R44 Clinical Trial Not Allowed) Apply for RFA DK 18 022 Funding Number: RFA DK 18 022 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $300,000 |
| HEAL Initiative: Integrated Approach to Pain and Opioid Use in Hemodialysis Patients: The Hemodialysis Opioid Prescription Effort (HOPE) Consortium - Clinical Centers (U01 Clinical Trial Required) Apply for RFA DK 18 030 Funding Number: RFA DK 18 030 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $500,000 |
| Stimulating Hematology Investigation: New Endeavors (SHINE) (R01 Clinical Trial Not Allowed) Apply for PAS 19 105 Funding Number: PAS 19 105 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Human Islet Research Network - Consortium on Modeling Autoimmune Interactions (HIRN-CMAI) (U01 Clinical Trial Not Allowed) Apply for RFA DK 18 013 Funding Number: RFA DK 18 013 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $600,000 |
| Development of New Technologies and Bioengineering Solutions for the Advancement of Cell Replacement Therapies for Type 1 Diabetes (R43/44 Clinical Trial Not Allowed) Apply for RFA DK 18 023 Funding Number: RFA DK 18 023 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Establishing a Cohort to Clarify Risk and Protective Factors for Neurocognitive Complications of Pediatric Type 1 Diabetes (T1D) - Planning Cooperative Agreements (U34 Clinical Trial Not Allowed) Apply for RFA DK 18 007 Funding Number: RFA DK 18 007 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $225,000 |
| Mass Spectrometric Assays for the Reliable and Reproducible Detection of Proteins/Peptides of Importance in Obesity Research (U01 Clinical Trial Not Allowed) Apply for RFA DK 19 001 Funding Number: RFA DK 19 001 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $1,000,000 |
| The KUH Predoctoral to Postdoctoral Fellow Transition Award (F99/K00 Clinical Trial Not Allowed) Apply for RFA DK 18 024 Funding Number: RFA DK 18 024 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Developmental Centers for Interdisciplinary Research in Benign Urology (P20 Clinical Trial Not Allowed) Apply for RFA DK 18 028 Funding Number: RFA DK 18 028 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $200,000 |
| George M. O'Brien Urology Cooperative Research Centers Program (U54 Clinical Trial Optional) Apply for RFA DK 18 029 Funding Number: RFA DK 18 029 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $1,000,000 |
| Multidisciplinary K12 Urologic Research (KURe) Career Development Program (K12 Clinical Trial Optional) Apply for RFA DK 18 027 Funding Number: RFA DK 18 027 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $600,000 |
| High impact, Interdisciplinary Science in NIDDK Research Areas (RC2 Clinical Trial Optional) Apply for PAR 19 202 Funding Number: PAR 19 202 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: Case Dependent |
| Limited Competition for the Continuation of the Chronic Kidney Disease Biomarkers Consortium (CKD BioCon) Data Coordinating Center (U01 Clinical Trial Not Allowed) Apply for RFA DK 19 501 Funding Number: RFA DK 19 501 Agency: National Institutes of Health Category: Food and Nutrition, Health Funding Amount: $500,000 |
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