Key Dates

Related Announcements

PA-18-935 - Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional

Issued by

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

Purpose

NIDDK is issuing this Notice of Special Interest (NOSI) to highlight the urgent need for epidemiologic studies of diabetes incidence and severity and its potential association with coronavirus disease 2019 (COVID-19) and the causative virus SARS-CoV-2.

Background

There is an urgent public health need to better understand the potential associations between COVID-19 caused by the SARS-CoV-2 virus and new-onset (incident) diabetes. While published data suggest an increase in new-onset diabetes following SARS-CoV-2 infection among children and adults in the U.S. and other countries, larger studies from more diverse populations in terms of race and ethnicity, socioeconomic status, and other social determinants of health (SDOH) are needed. Additionally, severity of diabetes at onset (e.g., diabetic ketoacidosis [DKA]) and diabetes type have not been well described. In addition, there is a need to further understand the significance of hyperglycemia presenting at the onset of COVID-19. Lastly, limited data are available to simultaneously assess potential changes in prevalence of known risk factors for hyperglycemia and type 2 diabetes such as glucocorticoid drugs used to treat COVID-19 and other health conditions, reduction in physical activity, and rising rates of obesity during the pandemic period that may account for some or all the increases in diabetes incidence observed in previous studies.

Research Objectives

Conduct an epidemiologic study of diabetes incidence and severity at onset and its potential association with COVID-19 and the causative virus SARS-CoV-2 among children and/or adults with appropriate comparison group(s) that takes into consideration other potential risk factors for the increase in diabetes incidence during this period.

• The primary focus of this study is diabetes incidence and severity and its potential association with COVID-19. Of particular interest is the timing of onset of diabetes following COVID-19 disease; severity of COVID-19 disease such as need for hospitalization, admission to intensive care, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO); significance of hyperglycemia at onset of COVID-19, period of the pandemic in terms of virus variants (alpha, delta, omicron, etc.); laboratory data on glucose and HbA1c; and medications used to treat COVID-19 and diabetes among identified cases.
• Of particular interest are datasets that allow for the distinction between types of diabetes (i.e., type 1, type 2, steroid induced) among incident diabetes cases using validated methods.
• Possible approaches to conducting this study include but are not limited to linking data sources and/or existing databases that incorporate EHRs and other forms of electronic health information and administrative data, clinical diabetes registries, and COVID-19 registries. We anticipate that this study will rely on linkages between diagnosis and procedure codes, laboratory test results, pharmacy records, clinical information such as height and weight to calculate body mass index (BMI), pre-existing health conditions, vaccination records, demographic information including gender, race and ethnicity, health insurance type, and indicators of SDOH.
• Individuals may be followed longitudinally (beyond the acute COVID-19 infection period) to assess severity, treatment, and/or remission of diabetes.
• Applicants are encouraged to consider the sample size needed to allow for calculation of differences in diabetes incidence between groups with and without COVID-19 and appropriate approaches to statistical modeling and testing. Of particular interest are other potential risk factors for diabetes such as reduced physical activity, increased BMI and use of glucocorticoid drugs to treat COVID-19 or other conditions, and other health conditions that may contribute to any observed differences in diabetes risk.
• This initiative will not support collection of new data such as those obtained through additional interviews or clinical visits and tests that will not be available at the time the application is submitted.

Applications that are not responsive to the above research areas will be withdrawn without review. The epidemiologic study in the proposed supplement does not need to be within the current scope of the active award.

Budget

NIDDK intends to make multiple awards based on this urgent competitive revision. The total budget for these epidemiologic studies is $3 million. Application budgets are limited to the current year direct cost budget, or $350,000 direct costs (whichever is less), exclusive of consortium FA costs. Budgets must reflect the actual needs of the proposed project.

Awardees may be asked to share preliminary findings with NIDDK program staff prior to the completion of the funding period and/or publication of their findings.

APPLICATION AND SUBMISSION INFORMATION

Applications in response to this initiative must be submitted using the following opportunity or subsequent reissued equivalent.

• PA-18-935 - Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)

This is intended to provide funds for NIH grantees applying to expand the scope of their active grant. The activity code will be the same as that of the parent award

When developing applications in response to this NOSI, all instructions in the SF424 (R&R) Application Guide and PA-18-935 must be followed, with the following additions:

Applications will be accepted until June 1, 2022, by 5:00 PM local time of the applicant organization. This NOSI expires on June 2, 2022. An application submitted in response to this NOSI that is received on/after the expiration date will be withdrawn.

• For funding consideration, all applicants must designate ”NOT-DK-22-017” (without quotation marks) in the Agency Routing Identifier field (Box 4b) of the SF424 (R&R) Form. Applications without this information in Box 4b will not be considered for this initiative.
• Requests may only be for one year (12 months) of support.
• The Research Strategy section of the application is limited to 6 pages.
• Only existing awardees of active NIDDK grants and cooperative agreements, excluding R03, R25, and all F, T and D series awards, are eligible to apply for this competitive revision.
• Applicants are strongly encouraged to notify the program contact at NIDDK that a request has been submitted in response to this FOA to facilitate efficient processing of the request.
• The urgent competitive revision budget is limited to no more than the amount of the current parent award and must reflect the actual needs of the proposed project.
• The parent award must be active when the application is submitted (e.g., within the originally reviewed and approved project period) and the work of this revision must be completed within the currently approved project period for the existing parent award.
• The earliest possible award date is August 1, 2022.
• For urgent competitive revisions to parent awards that include multiple PD/PIs, each PD/PI of the parent award must be listed as a PD/PI on the application, but another investigator or co-investigator team may lead the research project proposed in the competitive revision. Additional investigators may be funded through a subcontract to the award. The designated project leader(s) must be named as key personnel and have demonstrated prior epidemiologic experience relevant to the proposed research

REVIEW PROCESS

Applications will be evaluated for scientific and technical merit by an appropriate internal review panel comprised of NIDDK scientific staff in accordance with the review criteria specified in the FOA as well as these additional review criteria:

Significance of research:

• How will successful completion of the aims of the proposed study contribute to our understanding of the relationship between SARS-CoV-2 infection and incident diabetes including diabetes incidence rates and severity of diabetes at onset?

Feasibility of research:

• Is the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?
• Is the urgent time frame feasible for the proposed research?
• Are the PD/PIs, collaborators, and other researchers well suited and appropriate to carry out the project?
• Are the extant data sources such as existing cohorts, consortia with curated data and/or electronic health records and registries described in the application available to the researchers? Applicants are strongly encouraged to include a letter of agreement or support indicating that that the data are available and can be used for this supplement unless the data are currently in the public domain.
• Can important clinical and demographic characteristics of the population at risk such as BMI, race and ethnicity, gender, age, relevant co-morbidities and testing for COVID-19 be ascertained from the existing data?

Applications that are not responsive to terms of this NOSI will be withdrawn from consideration for this initiative.

Inquiries

Please direct all inquiries to the contacts in Section VII of the listed funding opportunity announcements with the following additions/substitutions:

Investigators planning to submit an application in response to this NOSI are encouraged to contact the program officer listed below to discuss the proposed project.

Please direct all inquiries to:

Jean M Lawrence, ScD, MPH, MSSA, FACE
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-435-6243
Email: jean.lawrence@nih.gov