Notice of Intent to Publish a Funding Opportunity Announcement for Understanding the Pathophysiology and Clinical Course of New-Onset Diabetes Following COVID-19 (U01 Clinical Trial Not Allowed)
Notice Number:

Key Dates

Release Date:
March 23, 2022
Estimated Publication Date of Funding Opportunity Announcement:
July 01, 2022
First Estimated Application Due Date:
December 20, 2022
Earliest Estimated Award Date:
July 01, 2023
Earliest Estimated Start Date:
July 01, 2023
Related Announcements


Issued by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)


The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications to establish a longitudinal cohort of individuals who developed diabetes following SARS-CoV-2 infection for the purpose of characterizing individuals who develop diabetes post-infection and understanding their clinical course.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. 

The FOA is expected to be published in late spring 2022 with an expected application due date in late fall 2022.

This FOA will utilize the U01 activity code. Details of the planned FOA are provided below.

Research Initiative Details

Emerging epidemiologic evidence suggests increased incidence of diabetes following SARS-CoV-2 infection. In addition to direct viral-mediated mechanisms, other pandemic-related factors may be contributing to development of diabetes. For instance, adults and children have gained weight during the pandemic. Rates of poor mental health, including substance use, depression, and anxiety have increased. Elevated psychosocial stress is associated with metabolic disease potentially through direct (elevated systemic inflammation) and indirect mechanisms (suboptimal lifestyle habits such as sleep and physical activity). Additionally, individuals with post-COVID-19 incident diabetes may have been predisposed to developing diabetes prior to acute COVID-19 and other pandemic insults, and this increased incidence may reflect accelerated onset or an unmasking of pre-diabetes in individuals. Many of these indirect pandemic factors are also likely root contributors to racial and ethnic disparities in metabolic health surrounding COVID-19. Research is needed to comprehensively characterize the onset, clinical course, and physiology of new-onset diabetes after COVID-19, and the relationships among predisposing factors, SARS-CoV-2 infection, and diabetes.

To address this need, the planned FOA will invite investigator-initiated applications to establish a controlled longitudinal observational multi-center clinical study to characterize new onset diabetes and its clinical course following COVID-19. This study would recruit adults and children with new onset diabetes observed after SARS-CoV-2 infection and fully characterize the participants metabolically and clinically. Participants would be followed for 1-2 years to monitor the natural history and characterize the course of diabetes and glycemic response to therapy and assess any potential complications.

One award will be made for a multi-center clinical study. This Notice encourages investigators with expertise and insights into this clinical problem to begin to consider applying for this new FOA, including developing the study design with an appropriate comparator group, as well as assembling adequate numbers of collaborators and recruitment sites. Given the need to rapidly recruit individuals with new-onset diabetes in the context of waning SARS-CoV-2 infections, it is critical to expedite the launch of the study. Therefore, planning prior to application and award is essential, so the study can start quickly once an award is made. Since only one award will be made, each applicant will be expected to assemble a multi-center study with demographic and geographic diversity.

An important goal of the planned FOA is to establish and understand if there is a new form of diabetes associated with the SARS-CoV-2 virus, to allow future investigation into how these patients should be treated.

Funding Information
Estimated Total Funding


Expected Number of Awards


Estimated Award Ceiling


Primary Assistance Listing Number(s)


Anticipated Eligible Organizations
Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 


Please direct all inquiries to:

Barbara Linder, M.D., Ph.D.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

(301) 594-0021

Maren Laughlin, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: (301) 594-8802